WO2007137887A1 - Système et procédé de commande du fonctionnement d'un appareil médical - Google Patents

Système et procédé de commande du fonctionnement d'un appareil médical Download PDF

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Publication number
WO2007137887A1
WO2007137887A1 PCT/EP2007/052273 EP2007052273W WO2007137887A1 WO 2007137887 A1 WO2007137887 A1 WO 2007137887A1 EP 2007052273 W EP2007052273 W EP 2007052273W WO 2007137887 A1 WO2007137887 A1 WO 2007137887A1
Authority
WO
WIPO (PCT)
Prior art keywords
index
values
patient
sequence
medical apparatus
Prior art date
Application number
PCT/EP2007/052273
Other languages
English (en)
Inventor
Franco Missoli
Original Assignee
Genesis Elettronica S.R.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Genesis Elettronica S.R.L. filed Critical Genesis Elettronica S.R.L.
Priority to EP07726786A priority Critical patent/EP2021076A1/fr
Publication of WO2007137887A1 publication Critical patent/WO2007137887A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/02—Magnetotherapy using magnetic fields produced by coils, including single turn loops or electromagnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/06—Magnetotherapy using magnetic fields produced by permanent magnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate

Definitions

  • This invention relates in general to a system and a method for controlling the functioning of a medical apparatus.
  • 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.
  • 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.
  • 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.
  • 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.
  • the emitting device is an electric/acoustic transducer which generally comprises a piezoelectric body in the form of a vibrating plate.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a further aim of the invention is to achieve the above-mentioned objective within the scope of a simple, rational and inexpensive solution.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • it can comprise an impedance meter or a signal receiver connectable to a chest-strap heart rate monitor, to an ECG, to an EEG
  • 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.
  • 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.
  • the interface means 3 comprise a display 4 and a keyboard 5.
  • the casing 2 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.
  • the generator 7 which supplies the electric/magnetic transducer
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the medical apparatus 1 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.
  • the processor extracts the patient's data and all the setting and functioning parameters of the apparatus 1.
  • 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.
  • 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.
  • 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 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.
  • the processor 22 commands the means for adjustment 23 to return the standard deviation value to within the interval.
  • 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.
  • 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.

Abstract

La présente invention concerne un procédé et un système pour commander le fonctionnement d'un appareil médical (1), lequel système comprend : un dispositif de détection (21) destiné à détecter une séquence chronologique de valeurs d'au moins un paramètre physiologique d'un patient, une unité logique (22) connectée au dispositif de détection (21) et prédisposée pour extraire un indice de la condition physiopathologique du patient à partir de la séquence de valeurs, et prédisposée pour comparer l'indice à une valeur de référence, et des moyens de réglage (23) pouvant être activés par l'unité logique (22) lorsque l'indice est en dehors d'un intervalle prédéfini autour de la valeur de référence, lesdits moyens (23) faisant varier les paramètres de fonctionnement de l'appareil médical (1) dans le but d'amener l'indice dans l'intervalle.
PCT/EP2007/052273 2006-05-26 2007-03-12 Système et procédé de commande du fonctionnement d'un appareil médical WO2007137887A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07726786A EP2021076A1 (fr) 2006-05-26 2007-03-12 Systéme et procédé de commande du fonctionnement d'un appareil mèdical

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITRE2006A000063 2006-05-26
IT000063A ITRE20060063A1 (it) 2006-05-26 2006-05-26 Sistema e metodo per il controllo del funzionamento di un apparecchio medicale

Publications (1)

Publication Number Publication Date
WO2007137887A1 true WO2007137887A1 (fr) 2007-12-06

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Application Number Title Priority Date Filing Date
PCT/EP2007/052273 WO2007137887A1 (fr) 2006-05-26 2007-03-12 Système et procédé de commande du fonctionnement d'un appareil médical

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Country Link
EP (1) EP2021076A1 (fr)
CN (1) CN101454047A (fr)
IT (1) ITRE20060063A1 (fr)
WO (1) WO2007137887A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009023432A2 (fr) * 2007-08-09 2009-02-19 Juvent Inc. Procédé et appareil pour thérapie par ultrasons
WO2014163020A1 (fr) * 2013-04-02 2014-10-09 帝人ファーマ株式会社 Dispositif de stimulation magnétique

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102014002173A1 (de) * 2014-02-19 2015-08-20 Dräger Medical GmbH Verfahren zur Signal- und Datenauswertung zur Bestimmung von Hinweissignalen für pathologische Zustände sowie entsprechende Vorrichtungen und Systeme

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004067090A1 (fr) * 2003-01-31 2004-08-12 Patex Group Ltd. Dispositif et procede pour mettre en oeuvre une magnetotherapie

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004067090A1 (fr) * 2003-01-31 2004-08-12 Patex Group Ltd. Dispositif et procede pour mettre en oeuvre une magnetotherapie

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009023432A2 (fr) * 2007-08-09 2009-02-19 Juvent Inc. Procédé et appareil pour thérapie par ultrasons
WO2009023432A3 (fr) * 2007-08-09 2009-04-30 Juvent Inc Procédé et appareil pour thérapie par ultrasons
WO2014163020A1 (fr) * 2013-04-02 2014-10-09 帝人ファーマ株式会社 Dispositif de stimulation magnétique
JPWO2014163020A1 (ja) * 2013-04-02 2017-02-16 帝人ファーマ株式会社 磁気刺激装置
US10342988B2 (en) 2013-04-02 2019-07-09 Teijin Pharma Limited Magnetic stimulation device

Also Published As

Publication number Publication date
EP2021076A1 (fr) 2009-02-11
ITRE20060063A1 (it) 2007-11-27
CN101454047A (zh) 2009-06-10

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