A SYSTEM AND A METHOD FOR CONTROLLING THE FUNCTIONING OF A MEDICAL APPARATUS

Technical Field

This invention relates in general to a system and a method for controlling the functioning of a medical apparatus.

Preferably the system and method are intended for controlling a medical apparatus of a type suitable for subjecting a patient to sound and/or magnetic therapy.

Background Art

Sound therapy, or sonophoresis, consists of subjecting a patient's biological tissues to sound waves of varying frequency and intensity according to the type of pathology to be treated. The propagation of sound waves in biological tissues produces mechanical, thermal and chemical effects, well known to experts in the field. In particular, the mechanical and thermal effects are of a macroscopic nature and produce respectively a massage action and endogenous heating of the area being treated, suitable for obtaining analgesic and anti-inflammatory results. The chemical effects are of a microscopic nature and caused by the significant forces of acceleration to which ependymal cells and the underlying astrocytes of the tissues are subjected upon the passage of the sound wave. Magnetic therapy, or magnetotherapy, consists in influencing the behaviour of certain types of cell by subjecting the cells to pulsating magnetic fields capable of inducing, especially at the membrane level, and to a lesser extent at the cytoplasmic level, small electric currents of a generally much lower intensity than that involved in natural stimulation of tissues. In this way, magnetotherapy can procure both analgesic and repair effects, for example more rapid calcification of bone fractures. Sonophoresis and magnetotherapy are usually carried out locally using particular application heads fitted with an appropriate emitting device

connected to an apparatus capable of supplying the device with the required electric current.

In the case of sonophoresis, the emitting device is an electric/acoustic transducer which generally comprises a piezoelectric body in the form of a vibrating plate.

In the case of magnetotherapy, the emitting device is an electric/magnetic transducer which normally comprises a coil wound around a core of ferromagnetic material, core which is supplied by a generator of pulsating electric current, A drawback of this type of therapy is that the sound and/or magnetic emissions passing through the biological tissues have a side-effect of generating a slight modification in the physiological condition of the patient.

In particular, if the characteristic parameters of the emissions, for example their intensity and/or their frequency fall within values tolerable for a patient's organism, the modification causes no problems of any kind. However, if the parameters exceed the values that the patient can tolerate, modification can cause the organism to enter into a state of suffering.

This state of suffering is often very slight, and produces no immediately perceptible effects, even by the patient; however it may worsen following prolonged exposure of the organism to emissions in excess of the patient's tolerance.

Further, since the values of the characteristic parameters of emissions that can be tolerated generally vary from one patient to another, it is impossible to determine these values univocally. For the foregoing reasons there is a greatly felt need at this time for medical apparatus that carry out sonophoresis and/or magnetotherapy to have a suitable control system, capable of regulating the apparatus' functioning according to the patient being treated.

In particular, the control system must be capable of adjusting the characteristic parameters of the emissions to which the patient is subjected in such a way that the emissions are sufficiently intense to produce effective

therapeutic effects yet at the same time always remain within the tolerance limits of the organism.

Recent medical research has shown that time-variation analysis of several physiological parameters enables rather reliable predictive indices of the physiopathological condition of the organism to be obtained.

Such research has in particular ascertained that heartbeat variability is an important indicator of the physiopathological condition of the cardiovascular and nervous apparatus of a patient. Heartbeat variability is intended to mean the variability of the interval of time between two successive heart contractions, usually referred to as the RR interval.

In particular, it has been demonstrated that heartbeat variability in a healthy and functional organism is highly accentuated, that is, the RR intervals differ greatly from each other. In contrast, in an ill or suffering organism, heart-beat variability is significantly reduced, that is, RR intervals tend to be very similar. A generally reliable index of heart-beat variability is the mean variability of a sequence of RR intervals recorded over a certain time period, measured from the standard deviation. It has in fact been observed that the standard deviation of RR intervals in a healthy organism is significantly higher that that in an ill or suffering organism, and that the standard deviation of RR intervals in an organism which progresses from a healthy state to a suffering state undergoes a significant reduction. Alternatively, the index of heartbeat variability can be measured effectively from the variance of the sequence of RR intervals.

The aim of this invention is to make available a system and a method for controlling the functioning of medical apparatus that satisfies the requirement mentioned above, i.e. that of subjecting patients to emissions that are sufficiently intense to produce efficacious therapeutic effects, while at the same time always remaining below the tolerance limit values of the individual's organism.

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A further aim of the invention is to achieve the above-mentioned objective within the scope of a simple, rational and inexpensive solution.

These aims are achieved by the invention as it is described in the claims that follow. In general terms, the invention makes available a method for controlling the functioning of a medical apparatus which includes the following phases: detecting a chronological sequence of values of an appropriate physiological parameter of the organism, by means of instrumental analysis performable on a patient under treatment; obtaining from this sequence of values a predictive index of the physiopathological condition of the patient's biological system, such as for example the cardiovascular system, the respiratory system, the nervous system or the muscular system; comparing the predictive index with a reference value that corresponds to the normal physiopathological condition of the biological system in question and, if the index is outside a preset interval around the reference value, adjusting the medical apparatus' functioning parameters in order to bring the predictive index within the interval. In this way, the control system of the present invention allows the medical apparatus to be adapted time-by-time to the characteristics of the patient undergoing the treatment, thus ensuring the patient is always subjected to emission values that make the treatment effective and are at the same time tolerable for the patient's organism. In a preferred embodiment of the invention, the present method includes systematically monitoring the above-mentioned physiopathological parameter, so as to obtain a sequence of values of the predictive index that illustrate the condition over time of the biological system to which the index refers.

More in particular, the method includes repeating the monitoring of the sequence of values of the physiopathological parameter a number of times and calculating the relative predictive parameter for each sequence.

Naturally, the values are detected at regular intervals at successive times, and each reading will last for the time required to acquire the sequence of values of the physiological parameter being examined.

In this context, the method includes comparing time-by-time the most recent index obtained with the above-mentioned reference value, and consequently suitably adjusting the apparatus' functioning parameters, This reference value is preferably calculated by processing a set of predictive index values, obtained prior to the most recently obtained index. For example, it can be calculated as the arithmetical mean of the said set of prior values, or as the weighted mean of these same values.

Thanks to these solutions, the comparison provides a measure of the variation over time of the predictive index, making it possible to estimate whether the response of the patient's organism to treatment is tending to procure a physiopathological improvement, i.e. whether the treatment is obtaining efficacious therapeutic effects without inducing a condition of suffering in the organism. Further, this comparison is performed in relation to a characteristic reference value of the actual patient being treated, so application of the method adapts automatically to the characteristics of each individual patient and is effective for all patients.

Disclosure of Invention By applying the present method, the invention makes available a control system of the functioning of a medical apparatus comprising: a sensor device that detects a chronological sequence of the values of a patient's physiological parameter; a logic unit predisposed to obtain from the chronological sequence of values a predictive index of the physio-pathological condition of a patient's

biological system, and predisposed to compare the predictive index with a reference value; and means for adjusting, activatable by the logic unit when the predictive index is outside a preset interval around the reference value, which means are capable of varying the medical apparatus' functioning parameters in such a way as to return the index within the interval.

In a preferred embodiment of the invention, the control system in question comprises a memory unit capable of storing a sequence of values of the predictive index, obtained by detecting at successive times various sequence of values of the physiological parameter and by processing each sequence of values.

Preferably, the sensor device comprises a fingertip blood flow monitor applied to a finger of the patient, which blood flow monitor is predisposed to detect sequence of RR intervals of the patient. Alternatively, it can comprise an impedance meter or a signal receiver connectable to a chest-strap heart rate monitor, to an ECG, to an EEG

(electroencephalograph) or to an MCG (magnetocardiograph).

Brief description of the Drawings

Further characteristics and advantages of the invention will emerge from the following description provided purely by way of non-limiting example, with the aid of the figures in the attached tables, wherein:

Figure 1 is a schematic view of a medical apparatus in accordance with the invention;

Figure 2 is a block diagram of the apparatus in Figure 1 ; - Figure 3 is a sectioned view of the operating head with which the apparatus in figure 1 is provided.

Best Mode for Carrying Out the Invention

The figures illustrate a medical apparatus 1 , which includes an external casing 2 upon which interface means 3 are positioned to allow the user to use the apparatus 1.

In the embodiment shown, the interface means 3 comprise a display 4 and a keyboard 5.

Within the casing 2 are housed two generators of electricity, 6 and 7, suitable respectively for supplying an electric/magnetic transducer 8 capable of generating sound waves, and an electric/magnetic transducer 9 capable of generating pulsating magnetic fields.

In particular, the generator 7 which supplies the electric/magnetic transducer

9 generates pulsating current.

In the illustrated embodiment, the electric/acoustic transducer 8 and the electric/magnetic transducer 9 are both housed within an operating head 10, which is destined to be applied to the skin of the patient at the tissues to be treated, and to be moved about within an area surrounding the point of application.

In this way, the sound waves and/or pulsating magnetic fields emitted by the operating head 10 are propagated locally within the tissues, subjecting the tissues to sonophoresis and/or magnetotherapy treatment.

Obviously, the effects obtainable from the abovementioned treatments depend essentially on the characteristic parameters of the emissions generated, for example on wave amplitude, frequency and shape: these characteristic parameters depend in turn on the functioning parameters of the medical apparatus 1 , such as for example the intensity of the current supplied by the generators 6 and 7.

In particular, whenever the sound and magnetic emissions are generated simultaneously and/or successively and/or alternately, the synergic action thereby produced has the effect of drastically reducing treatment time, and of significantly increasing the depth of penetration of any pharmaceutical substances previously spread on the skin in the form of creams or unguents.

As shown in figure 3, the operating head 10 comprises a beaker-shaped external body 1 1 , internally of which an electronic card is housed that manages the functioning of the transducers 8 and 9, respectively of sound waves and of pulsating magnetic fields.

In greater detail, the magnetic transducer 9 is housed internally of the body 11 and comprises a coil 13 wound on a reel 14 exhibiting a hole 15, which hole 15 is is a through-hole, central of the reel 14 and stretching from one end to the other thereof. The hole 15 houses the ferromagnetic core of the coil 13, which comprises a cylindhca permanent magnet 16, also provided with a central through-hole 17 extending from one end to the other of the magnet 16.

The electric/acoustic transducer 8 is positioned below the magnetic transducer 9 at the mouth of the body 11. In the illustrated embodiment, the electric/acoustic transducer 8 includes a piezoelectric plate connected to the electronic card 12 by means of a stem 18 which is inserted into the hole 17 of the permanent magnet 16.

Further, a cooling fan 19 is positioned within the body 1 1 , which fan expels the heat generated by the coil 13 through ventilation holes 20 which place the internal volume in communication with the outside.

In accordance with the invention, the medical apparatus 1 is provided with a control system predisposed to manage the functioning thereof in such a way that the sound and/or magnetic emissions produce effective therapeutic effects, without causing the patient troublesome side-effects. As schematically illustrated in figure 2, the control system comprises a sensor device 21 which is applied to the patient undergoing the treatment to detect a sequence of RR intervals of the patient's heart over a preset time interval. Preferably, the sensor device 21 comprises a fingertip blood flow monitor which is applied to the finger of the patient; however it could alternatively comprise an impedance meter or a device for receiving signals from a chest- strap heart rate monitor, or from an ECG, EEG or MCG. The sensor device 21 is connected to a processor 22 capable of processing the sequence of RR intervals detected, and capable of controlling usual means for adjustment 23.

In particular, the means for adjustment 23 are capable of acting on functional devices of the apparatus 1 , for example the generators of electricity 6 and 7, in such a way as to adjust the functioning parameters of the apparatus 1 and thus the characteristic parameters of the sound and/or magnetic emissions generated.

A first and a second memory unit, respectively 24 and 25, are associated to the processor 22.

In the first memory unit 24 the data processed by the processor 22 are stored, so that the data are subsequently available to the processor 22 itself. The first memory unit 24 can alternatively be incorporated into the processor 22.

The parameter settings of the medical apparatus 1 relating to the pathology to be treated are stored in the second memory unit 25. The setting parameters comprise the essential data of the patient, the type of treatment the patient is undergoing, together with the number of treatments and the wave frequency, amplitude and shape, of both the sound emissions and the magnetic emissions.

In particular, the second memory unit 25 can alternatively be incorporated into the processor 22, into the first memory unit 24, or as in the embodiment shown, be associated with a second processor 26 situated on a removable support, such as for example a smart card 27.

In the latter case, use of the medical apparatus 1 is provided with a reader 28 of the smart card 27, connected to the processor 22. The functioning modality of the medical apparatus 1 requires the user to insert the suitably programmed smart card 27 into the reader 28. Upon insertion of the smart card 27, the processor extracts the patient's data and all the setting and functioning parameters of the apparatus 1. In this way, the treatment can be advantageously performed without a professional operator being present, since once the smart card 27 has been programmed the user needs only to insert the card 27 into the appropriate reader 28.

According to the treatment that the patient is undergoing, the processor 22 activates, in succession and/or alternately, the electric/acoustic transducer 8 and the electric/magnetic transducer 9, for the preset treatment time. During treatment, the control system systematically repeats, in accordance with a regular temporal pattern, the succession of phases described below. The sensor device 21 registers a sequence of RR intervals of the patient's heart.

The sequence of RR intervals is made available to the processor 22, which is predisposed to extract from the sequence a predictive index of the physiopathological condition of the patient's cardiovascular system, measured from the standard deviation.

The processor 22 then compares the standard deviation with a reference value that corresponds to a normal physiopathological condition of the cardiovascular system, and finally stores the value of the standard deviation in the first memory unit 24.

If comparison evidences that the standard deviation is outside a preset interval around the reference value, the processor 22 commands the means for adjustment 23 to return the standard deviation value to within the interval. In particular, the processor 22 calculates the reference value time-by-time by calculating the arithmetical mean of a discrete set of values of the standard deviation which, stored in the memory unit 24, were obtained prior to the most recent value which is to be compared.

It should be noted that in accordance with an alternative embodiment of the invention, the predictive index of the cardiovascular system of the patient can also be measured from the variance of the sequence of RR intervals detected by the sensor 21.