EP3154418A2 - Dispositif pour vérifier le statut d'intégrité d'une cavité d'un patient - Google Patents

Dispositif pour vérifier le statut d'intégrité d'une cavité d'un patient

Info

Publication number
EP3154418A2
EP3154418A2 EP15798550.8A EP15798550A EP3154418A2 EP 3154418 A2 EP3154418 A2 EP 3154418A2 EP 15798550 A EP15798550 A EP 15798550A EP 3154418 A2 EP3154418 A2 EP 3154418A2
Authority
EP
European Patent Office
Prior art keywords
electrodes
current
long
cavity
shaped element
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP15798550.8A
Other languages
German (de)
English (en)
Inventor
Antonio Talluri
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AKERN Srl
Original Assignee
AKERN Srl
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 AKERN Srl filed Critical AKERN Srl
Publication of EP3154418A2 publication Critical patent/EP3154418A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0537—Measuring body composition by impedance, e.g. tissue hydration or fat content
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
    • A61B5/4542—Evaluating the mouth, e.g. the jaw
    • A61B5/4552—Evaluating soft tissue within the mouth, e.g. gums or tongue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4869—Determining body composition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive

Definitions

  • the present invention concerns the technical field relative to medical instruments.
  • the invention refers to an instrument that allows the monitoring and check of anatomical cavities such as the oral, vaginal and rectal cavities, in order to identify, in an efficient manner, eventual injuries and alterations of the tissues in general and of the mucous membranes in ⁇ articular ⁇
  • anatomical cavities such as the oral, vaginal and rectal ones, as known, is at the basis of the prevention of many pathologies, some of which are particularly serious, such as neoplasia.
  • a common injury that for the patient can be interpreted as a surface scratch or a simple swelling of the mouth can instead be a sign of . a rather serious infection, if not even an injury of the neoplastic type.
  • an obstetrical forceps device is described which is configured to make an exploration in the vaginal cavity, in particular a state of dilatation thereof in case of childbirth.
  • an obstetrical forceps element is configured either for grasping or for divaricating an end and remaining fixed in a pre-established position, therefore allowing a local monitoring in a pre-determined point (in this case, precisely, a monitoring of an increase or decrease of volume or area) .
  • the obstetrical forceps element in a further embodiment, is substituted with an element having a sort of adhesive surface on which the electrodes are found and also this, therefore, is configured to be applied and remain fixed in a specific point. .. . ...
  • WO2010/060152 describes the use of a siluride configuration system, for example suppository or cigar.
  • Such conformations are ideal fo the vaginal or rectal cavities but not, by virtue of the conformation thereof, for oral cavities since they cannot reach or detect efficiently zones such as the under-tongue , or the intra- jaw internal angles at least without causing annoyance or excoriations. Further, their shape impedes the tonometric exploration of small segments of the mucous membranes present inside cavities with very irregular morphologies, such as the oral ones.
  • Such a device (1) comprises a generally long-shaped element (2, 5) suitable for being ' inserted in the oral cavity to be inspected,
  • said element (2, 5) is provided with at least two electrodes (a, a', b, b' ) to detect a voltage drop following an input current (II) that is injected in the person.
  • such a device in use, is inserted in the oral cavity with such electrodes in contact with one or more internal zones of the cavity.
  • a current is injected in the person and, circulating in the body of the person, is withdrawn from said two electrodes of the device in question.
  • the device is also further configured to transmit such an intercepted voltage to an apparatus (10) , for example a voltmeter and/or a phasemeter, programmed to process the values in indexes of resistance and of reactance .
  • an apparatus for example a voltmeter and/or a phasemeter, programmed to process the values in indexes of resistance and of reactance .
  • said long-shaped element comprises .a handle (5) and a head (2) on which the electrodes are positioned, said head being T-shaped, or fork-shaped, and configured to be moved, in use, insid ⁇ the oral cavity with the electrodes in scraping contact with the walls of the ' Oral cavity.
  • T, O or fork-shaped solution is optimal for an oral inspection, allowing to reach zones that are not easily reached in another way, such as the under-tongue section .
  • FIG. 1 shows a prospective view of a prototype of the apparatus in accordance with a first embodiment of the invention and particularly suitable for the inspection of the oral cavity;
  • FIG. 2 shows just the part of the device that is inserted in the oral cavity and provided with handle to grasp it and manecute it;
  • FIG. 3 shows just the head in which two electrodes injecting current ' and two receiving electrodes are arranged
  • Figure 5 shows the entire device that comprises also a processor and the current generator; .
  • FIG. 6 and 7 show some graphics (nomograms with tolerance zones and confidence regions) on ' which the • measurements detected are plotted .in order ⁇ to verify if the specific measurement made falls within a scope of normality or is indicative of an anomaly;
  • FIG. 8 shows a variant in which the head is provided with just receiving electrodes, while the electrodes that inject the current are arranged on an external device, such as transcutaneous electrodes of the pre-gelatine and adhesive type;
  • Figures 9 and 10 show constructive solutions of the receiving electrodes, and applicable also to all the other solutions described
  • FIG. 11 and figure 12 show an example of crossing of the current in the tissues in accordance with the solution relative to the head that comprises also the injecting electrodes;
  • figure 1 . 3 shows a constructive variant suitable for inspecting anal and vaginal cavities
  • FIG. 14 is a further variant that allows the check of delimited and even point parts of area of cavity.
  • the knowledge of electrical parameters can help to interpret the normality or not of pre-determined physiological status.
  • the reactance Xc and the resistance R have long been used in order to obtain the status of body hydration, while the phase angle is an excellent predictor of survival in different pathologies.
  • a generator was foreseen capable of generating a reference signal of alternate voltage at SOKhz or at two frequencies (5Khz and lOOKhz) that was injected in a section of the body of the patient through pairs of plates or electrodes. In the case of plates, these were grasped by the hand of the patient through thumb and fingertip of the remaining fingers. In that manner, the electrical signal was injected from a plate and crossed the body that functioned as conductor to reach the opposite plate.
  • a discriminator calculated the deviation of the input signal (the one injected in a plate) with respect to the output signal (current that supervened to the opposed plate) after crossing such a part of the body.
  • the deviation is, in fact, the non-synchrony between the current and, the voltage that an electronic circuit is capable of quantifying visualizing it on the "display" as reactance and using an implementa ion of formulas already known .
  • the instrument described in _ ITFI20050202 is not in fact structured to result to be intertable in the oral cavity, or in other cavities, and therefore it is not suitable for being used for obtaining measurements in the cavities of the patient. Moreover, though doing some electrical measurements, these are not interpolated in order to identify alterations of the bioelect ical parameters in zones or sections of the oral cavity or of the cavities where inserted.
  • Figure 1 shows in an axonometric view a device 1 in accordance with a first embodiment of the invention.
  • the device described in the figures from 1 to 4 is particularly suitable for an inspection of the oral cavity.
  • the device 1 comprises a head 2 that is connected to a handle 5.
  • the handle terminates with an electrical wire 3 of connection to an electrical press 4 which, as better clarified below, is connected to a further instrument 10, such as a processor.
  • figure 3 shows a solution of a T-shaped head at whose end are placed four metallic electrodes (or of other conducting material) in the shape of spheres of small diameter.
  • the spheres are connected each one to an electrical wire and the assembly of such wires runs along the handle to terminate on the press 4.
  • I current
  • V voltage
  • FIG. 4 A further constructive solution is shown in figure 4 in which the head can be fork-shaped and foresees at its ends four electrodes (a, b, b' , a' ) through which to inject the current and detect the measurement thereof in volts and/or phase.
  • the head foresees four conducting elements (a, b, b' , a' ) , preferably cros sbow-like, and that terminate preferably with four spheres (a, b, b' , a' ) of small diameter or with four small plates of a shape ldoneous to rest internally on different points of the oral mucous membranes or on the tongue.
  • each conducting element terminates and is connected with an electrical wire and the assembly of such electrical wires terminate in the press .
  • the head 2 has such a size as to be inserted in the mouth in such a way as to be able to inspect it. It can have the size of a fork or of dental instruments of common use in such a way that the doctor can insert it in the oral cavity without creating big encumbrances to the patient and bringing the electrodes in contact with all the parts to be inspected such as the palate, tongue, under- ongue, gums, cheek, etc., by. simply moving the head 2 inside the oral cavity.
  • FIG. 5 shows the wire 3 that connects to an electronic processor 10, for example a PC 10 or anyway a device idoneous to the tetra-polar technique, through which the current injection can be controlled a d the voltage or phase can be analyzed.
  • the injection of current can take place through a specific generator that can be included in the structure of the processor or can be an independent external apparatus and that is connected to the handle of the instrument to send the current to the two pre-placed electrodes.
  • a voltmeter or systems sensitive to the phase allow to determine the measurements of impedance, resistance and reactance ⁇
  • the handle can comprise inside it a generator of current.
  • the wire 3 as explained above, although indicated with a single wire, foresees two output wires to inject the current from the generator to the two electrodes (a, a' ) and two return wires to obtain the reading of the voltage from the electrodes (b, b' ) to the processo .
  • the return signal is then interpreted as described below .
  • the current (Ii) in exit from the electrodes (a, a' ) arrives in contact with the mucous membrane that conducts current.
  • the status of conduction varies obviously on the basis of the physiological status of the mucous membrane, inflammatory status or other and re-enters displaced of a predetermined quantity ( ⁇ ) to the electrodes (b, b' ) in the shape of current ( 12 ) .
  • the displacement ( ⁇ ) depends on the physiological status of the mucous membrane or of the tissues in general.
  • a pre-detormined pathology such as an in lammation, alters the tissues and their content of liquid and therefore the electrical conductivity.
  • the values of R and Xc deriving from the voltage and the asynchrony versus current arrive to the PC, which is programmed according to known formulas to calculate the regions of confidence and zones of tolerance, exactly as described in the known art with the denomination of measurement technique of the bio-impedance with 4 -wire vector analysis tetra-polar system (BIVA) .
  • the voltage drop is detected from which a voltmeter detects the impedance Z, while systems sensitive to the phase allow to determine its components.
  • the processor calculates reactance Xa , resistance R and displacement of current ( ⁇ p ) once the current injected and the current in return are known, in particular the voltage drop.
  • a graph can therefore be interpolated experimentally, as that of figure 6 (bi-variate statistical analysis) in which the area Al represents an area obtained through experimental measurements of reactance Xc and resistance R on a specimen of population used as healthy checks with measurementa of the anatomical cavities (oral, vaginal, rectal) .
  • the measurements obtained are plotted and a graphic is obtained that delimits an area hi of normality ⁇ fiftieth percentile of the healthy checks)
  • the area A2 represents a zone of deviation from the norm (that can al$o be delimited in ellipses that englobe the seventieth and ninetieth percentile) .
  • the graphic can be created just once initially as a fixed datum and can be memorized and used by the processor .
  • the resistance and reactance values obtained through a distance between the constant electrodes, and therefore expression of specific resistivity (Ohm/cm) are positioned in said graphic, verifying a position inside the area of normality or not. In this manner, in an immediate way, it is verified on the screen if the patient examined falls within a condition of normality (area of the 50%) or not and it can be verified exactly the point in which there is an anomaly zone indicative of a possible injury.
  • the doctor can pass the instrument in contact in the various parts of the cavity under exam and verify on the display if each point that he examines (and of which the processor obtains reactance and resistance) falls within the area of the graphic Al or not.
  • figure 13 or 14 which is identical to the preceding one except for its shape, which is particularly idoneous for the insertion in cavities such as the vagina or rectum.
  • a cigar-shaped or suppository-shaped body can be selected, particularly extracted and with round ends .
  • Electrodes as usual, are foreseen arranged in circular form around the perimeter of the body, or semi- perimetral electrodes or simply at small “spots" for rendering them idoneous to observe just a side or a minimum portion of the cavity.
  • the interpolable graphic can be created on the basis of the phase ( ⁇ ) as per figure 7 and that defines always an area of normality Al and an area of non-normality ⁇ 2.
  • the instrument is inserted in the oral cavity to detect measurements of punctual reactance, resistance and phase which are plotted on the memorized statistical graphic to show in video if all the values measured fall within an area of normality or no .
  • said variant differs from the preceding ones in that the injection of current does not take place through two electrodes arranged in the body of the instrument but through an external, apparatus.
  • figure 8 shows schematically a patient in which the current is injected through an external generator provided with two electrodes that can be comfortably applied to the cheeks and therefore are not integrated in the head 2 (in the case of check of the oral cavity) .
  • the input current (II) circulates among the tissues of the oral cavity and is measured in voltage and phase (current 12) displaced of the value detected by the two single electrodes present in the head 202.
  • the electrodes (b, b' ) present on the head 202 can be of different shapes.
  • figure 9 shows a solution in which the electrodes can be compared to buttons ("spot” solution) .
  • the solution of figure 10 instead shows a conducting ring obtained on a part (semi-ring) or the entire perimeter of the head (entire ring) .
  • the solution in which the head foresees two single receiving electrodes has the advantage of allowing to obtain a head of reduced size.
  • the head includes both the electrodes injecting the current and the receiving electrodes
  • the modality of injection changes locally on the basis of the position in which the head is inserted in contact with the mucous membranes.
  • the angulation of insertion of the electrodes these can result to be parallel to the tissues, or with respect to them, orthogonal or inclined.
  • Figure 11 and figure 12 schematize two possible opposed situations.
  • the figures show a section of tissue in which the strips in black represent the muscular fibers.
  • the current runs parallelly to the muscular tissues (band) and is however possible to observe it transversally by means of the positioning of the fork and this modifies signif cantly the capacitive measurement (reactance).
  • the current generator In the case of injecting electrodes placed on an external device, device connected to the current generator as per figure 8, its positioning is substantially always the same and therefore the modality of crossing of the current in the tissues Is always the same.
  • the head and the handle can be integral in a single piece and in a sterilizable and low cost material (for example plastic, PVC, etc) .
  • the wire 4 can, for example, be detachable from the electrodes in such a way that the head and handle can be inserted in . a sterilization apparatus.
  • the head can be detachable from the handle in such a way that the handle is, for example, sterilizable and the head is single-use.
  • the solution of figure 13 can be in the shape of a handle that is connected to a head of an idoneous shape, for instance, detachable and/or sterilizable as described.

Abstract

La présente invention concerne un appareil innovant (1, 10) pour la vérification d'une cavité d'un être humain, par exemple la cavité orale, rectale ou vaginale. Un tel appareil comprend : - un générateur permettant de générer et d'injecter un courant d'entrée pré-déterminé (I1) dans une personne ; - un élément de forme allongée (2, 5) approprié pour être inséré dans la cavité à inspecter et pourvu d'au moins deux électrodes (a, a ', b, b') pour recevoir un courant de retour (I2) à la suite du courant d'entrée (I1) injecté dans la personne lorsque ledit élément de forme allongée se retrouve inséré dans la cavité avec lesdites électrodes en contact avec une ou plusieurs zones de la cavité à inspecter ; - un appareil (10) étant en outre prévu avec lequel l'élément de forme allongée est placé en communication de manière à transmettre ledit courant (I2) intercepté par les électrodes vers ledit appareil (10), l'appareil étant programmé pour traiter les valeurs de courant injecté (I1) et celles détectées en retour (I2).
EP15798550.8A 2014-06-11 2015-05-18 Dispositif pour vérifier le statut d'intégrité d'une cavité d'un patient Withdrawn EP3154418A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITFI20140145 2014-06-11
PCT/IB2015/053646 WO2015189727A2 (fr) 2014-06-11 2015-05-18 Dispositif pour vérifier le statut d'intégrité d'une cavité d'un patient

Publications (1)

Publication Number Publication Date
EP3154418A2 true EP3154418A2 (fr) 2017-04-19

Family

ID=51229985

Family Applications (1)

Application Number Title Priority Date Filing Date
EP15798550.8A Withdrawn EP3154418A2 (fr) 2014-06-11 2015-05-18 Dispositif pour vérifier le statut d'intégrité d'une cavité d'un patient

Country Status (2)

Country Link
EP (1) EP3154418A2 (fr)
WO (1) WO2015189727A2 (fr)

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Publication number Priority date Publication date Assignee Title
ITUB20155964A1 (it) * 2015-11-27 2017-05-27 Sbi S R L Un dispositivo, ad esempio in forma di un bracciale o cinturino, in grado di monitorare le variazioni dello stato di idratazione corporea, in particolare durante lo svolgimento di attivita? sportiva
ITUA20161403A1 (it) 2016-03-07 2017-09-07 Akern S R L Un guanto provvisto di elettrodi per un controllo a display della prostata.

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CA2246292A1 (fr) * 1996-02-16 1997-08-21 Smithkline Beecham Consumer Healthcare Gmbh Brosse a dents
US6174290B1 (en) * 1998-04-10 2001-01-16 Leader Technics Co., Ltd. Ovulation period detecting apparatus and ovulation period detecting method for mammals
GB0421884D0 (en) * 2004-10-01 2004-11-03 Idmos Plc Method and apparatus for monitoring the structure of a tooth
US7155269B2 (en) * 2005-03-11 2006-12-26 Tanita Corporation Stress evaluation apparatus
ITFI20050202A1 (it) 2005-09-29 2007-03-30 Akern S R L Un procedimento ed un dispositivo domiciliare di misura per l'autocontrollo del grado di idratazione di un soggetto
US20090137925A1 (en) 2007-11-23 2009-05-28 Divya Cantor Impedance Spectroscopy Cervix Scanning Apparatus and Method
US8750978B2 (en) * 2007-12-31 2014-06-10 Covidien Lp System and sensor for early detection of shock or perfusion failure and technique for using the same
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US20130071807A1 (en) * 2011-09-20 2013-03-21 Alexander Franz Doll Iontophoretic oral care devices with automatic oral care implement detection and mode selection
CN103815903A (zh) * 2012-11-16 2014-05-28 张春雨 一种便携式前列腺癌筛选扫描设备

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Also Published As

Publication number Publication date
WO2015189727A2 (fr) 2015-12-17
WO2015189727A3 (fr) 2016-04-07

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