WO2019022646A2 - Gilet pour examen électrophysiologique non invasif du coeur - Google Patents

Gilet pour examen électrophysiologique non invasif du coeur Download PDF

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Publication number
WO2019022646A2
WO2019022646A2 PCT/RU2018/000504 RU2018000504W WO2019022646A2 WO 2019022646 A2 WO2019022646 A2 WO 2019022646A2 RU 2018000504 W RU2018000504 W RU 2018000504W WO 2019022646 A2 WO2019022646 A2 WO 2019022646A2
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WO
WIPO (PCT)
Prior art keywords
vest
electrodes
layer
composite material
corset
Prior art date
Application number
PCT/RU2018/000504
Other languages
English (en)
Russian (ru)
Other versions
WO2019022646A3 (fr
Inventor
Леонид Антонович БОКЕРИЯ
Ольга Леонидовна БОКЕРИЯ
Натела Теймуразовна САЛИЯ
Ольга Викторовна МЕТЕЛЕВА
Зураб Константинович ЦИРГИЛАДЗЕ
Original Assignee
Леонид Антонович БОКЕРИЯ
Ольга Леонидовна БОКЕРИЯ
Натела Теймуразовна САЛИЯ
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 Леонид Антонович БОКЕРИЯ, Ольга Леонидовна БОКЕРИЯ, Натела Теймуразовна САЛИЯ filed Critical Леонид Антонович БОКЕРИЯ
Publication of WO2019022646A2 publication Critical patent/WO2019022646A2/fr
Publication of WO2019022646A3 publication Critical patent/WO2019022646A3/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, 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
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/6804Garments; Clothes
    • A61B5/6805Vests

Definitions

  • the invention relates to medical equipment, namely, the technique for cardiovascular surgery and cardiology, and can be used for diagnostics and complex treatment due to exposure of the patient to low-intensity electromagnetic radiation in cardiovascular diseases, including in the online mode remotely .
  • the principle of non-invasive activation cardiac mapping is based on the principle of the inverse problem of electrocardiography in the form of computational potentials reconstruction potential of the electric field on the myocardial surface according to the measured potential using a system of electrodes placed on the body surface.
  • the reconstruction of the atrial and ventricular myocardial excitation sequence, the determination of the sources of ectopic myocardial excitation and other electrophysiological data is further performed using automated analysis of reconstructed electrograms (RU patents N ° 2435518, 2417051, N2 2468742, application US LL 20160331263, US patent JV ° 8175674).
  • Non-invasive activation cardiac mapping has the following advantages over invasive mapping. It can be used for simultaneous mapping of all four chambers of the heart, simultaneous mapping on the endocardium and epicardium of the heart, mapping for one cardiac cycle, mapping of arrhythmias, characterized by aperiodic electrophysiological processes.
  • Non-invasive activation mapping can be used for the purpose of preoperative diagnosis of complex heart rhythm disorders prior to surgical or interventional treatment; for carrying out postoperative control, for the purpose of diagnostics of recurrent and incisional arrhythmias after surgical or interventional treatment; if necessary, electrophysiological and topical diagnosis of rhythm disorders characterized by aperiodic or rarely repeated electrophysiological processes.
  • cardiac mapping in patients with contraindications for cardiac catheterization during cardiac resynchronization therapy.
  • a device for non-invasive electrophysiological study of the heart is known (patent RU JVs> 2417051, 2008, ⁇ 61 ⁇ 5/0402), in which to conduct a non-invasive electrophysiological study of the heart, designed to reconstruct the dynamics of the electric field of the heart in the internal points of the chest, mapping using a system of recording electrodes placed on a special vest that is put on the patient during the examination of the chest, then processing dissolved ECG signals in real time using hardware and software.
  • the vest includes disposable electrodes, glued to the surface of the chest in the form of horizontal five to eight belts located at equal distances along the vertical and circumference of the chest.
  • the recording electrodes are fixed using a vest on the surface of the chest, they reconstruct the dynamics of the electric field of the heart in the inner points of the chest in real time and carry out activation epicardial mapping to obtain epicardial isopotential and isochronous maps (myocardial activation patterns) in a non-invasive way.
  • Performing a system of electrodes in the form of a regular grid (structure) allows for the diagnosis of coronary heart disease in patients with a complete blockade of the left or right bundle of His, a two-beam blockade and the possibility of multiple re-conducting without the use of a radiopharmaceutical.
  • the closest solution is a device for cardiomonitoring (patent RU ⁇ "168748, 2016, ⁇ 61 ⁇ 5/0432), which uses a detachable corset-vest that includes 5 electrodes, a recorder module, an independent memory module, with a registration program, recording and transmission ECG, wireless communication module from electrodes to
  • All electrodes are integrated into a detachable corset (vest), made of elastic belts of the same width - two shoulder straps and a chest strap. All belts are made of two parts, connected by clasps of any known type, for example, Velcro. The fit of the corset to the patient's figure is made by changing the length of the belts with the help of a fastener.
  • the design of the corset (vest) has an increased manufacturability and versatility of use for patients of different constitutions. Shoulder straps provide a clamp when applying the electrodes of the right and left side.
  • the proposed construction of a detachable corset is made of elastic belts of the same width, which ensures high-quality contact of the electrodes with the patient's body.
  • the nodes of the device are made wireless and integrated into a detachable corset.
  • the disadvantages of the known construction are a small number of electrodes, which does not allow to obtain a high-quality electrocardiogram, which affects the accuracy of diagnosis, as well as an insufficient amount of the pectoralis.
  • the objective of the proposed execution of the vest is to increase the reliability of diagnosing the state of the human heart system and versatility for patients of different constitutions by ensuring quality contact of the electrodes with the patient's body.
  • a vest containing a shoulder part of two belts of the same width and a detachable corset part, including electrodes made wireless, integrated into a corset part, having a front and backrest of the same size, connected by the shoulder and side plates, with the possibility of being completed with a set of additional paired parts having respectively discretely increasing width, a signal measuring unit made wireless, while the corset part is conformal made of composite material, the first layer of composite material has openings for accommodating electrodes in it and a signal measuring unit, while the sets of electrodes are made in the form of regular sections, each electrode in the section is connected with a microcontro by means of conductors
  • the second layer of composite materials contains a flexible printed circuit board to which microcontrollers are connected, the output of the flexible printed circuit board is connected to the signal measuring unit, the third layer of composite material is protective.
  • holes for wireless sensors such as photo-plezmitograms (FIGs), temperature sensors, etc. can be additionally provided in the corset part of the vest in the first layer.
  • FOGs photo-plezmitograms
  • temperature sensors etc.
  • a magnetic inductor can be attached on top of the electrode if necessary by electromagnetic effects.
  • FIG. 1 shows the equipment of the vest, where:
  • FIG. 2 shows the location of the electrodes and their numbering on the back of the vest.
  • FIG. 3 shows the implementation of the second layer of the vest with the connection diagram of the electrodes, where: front 1 and back 2, side plates 5 and 6, electrodes 13, conductors 14, microcontroller 15, flexible printed circuit 16, signal measuring unit 17.
  • the vest adjacent to the surface of the human body, is made of a thin lightweight flexible composite material (for example, silicone, woven base, etc.), ensuring the stability of its geometric parameters in length and width.
  • the vest has in front of 1 and back 2 of the same size, connected by shoulder 3, 4 and side plates 5 and 6 using a wide elastic band 7 and fasteners 8 and 9, which allow to jointly adjust the parameters of the vest to ensure its precise and tight fit to the torso surface figures, which is achieved conformality.
  • the vest is completed with a set of additional paired etals 11 and 12, each having a discretely increasing width, after connecting to the vest, ensuring the appropriate size of the product along the chest line.
  • the vest has on the sides in front of it, attached halves of fasteners 8 and 9 (detachable zipper tape), to which additional parts 11 and 12 can be added or removed by fastening.
  • the first layer of the composite material of the vest has holes for accommodating an electrode system 13i, where i is from 1 to n (n is the number of electrodes).
  • FIG. 2 shows the placement of up to 83 electrodes - from 131 to 13g 3 , connected by conductors to microcontrollers. The numbering of the electrodes is necessary for accurate coordination of the location of the electrodes with the intercostal space of the chest in a non-invasive study and diagnosis of the heart.
  • the second layer contains a conductive structure in the form b flexible printed circuit boards to the sections of the electrodes 13j, connected to the microcontroller, the third layer is protective.
  • Electrodes 13 Over the entire surface of the first layer of the vest, at an equal distance from each other (2.5x2.5 cm) silver-silver electrodes 13 are inserted, with a gel coating, tightly adjacent to the surface of the body. The exact location of the electrodes 131 relative to each other allows you to more accurately process the received signals. Every 6-10 (no more than) electrodes with the help of conductors are combined into sections connected by one microcontroller. Microcontrollers are interconnected by a flat flexible printed circuit board (HPP). Each cable can conduct up to 10 electrical signals, that is, it can serve 10 ECG electrodes. The upper section is serviced by one microcontroller (10 lines), the second one together with the first section (20 lines), the lower section is connected by the previous two sections of the main switchboard (30 lines).
  • HPP flat flexible printed circuit board
  • each block can be made inclined through cuts with a length commensurate with the dimensions of the input sensors, for example, 25 mm and 5 mm wide, to accommodate sensor plates: photoplethysmogram (FIG), temperature sensors And others. If necessary, electromagnetic exposure on the ECG electrode can be attached magnetic inductor.
  • FOG photoplethysmogram
  • the wires from the vertical data acquisition lines and FPG electrodes are in working condition on the outer side of the vest and are directed down to the signal measuring unit.
  • the microcontrollers are connected via the GPP with a signal measuring unit.
  • each vertical row of sections of electrodes with a microcontroller (line 14-16) is integral, each has its own position based on the vest due to the different number of contacts for the electrodes and the number of microcontrollers.
  • cardiovascular diseases anterior and posterior parts of the interventricular septum (MLS), right ventricle, apex, anterior, lateral and posterior walls of the left ventricle
  • MLS interventricular septum
  • apex anterior, lateral and posterior walls of the left ventricle
  • the proposed solution allows to simplify the process of putting on and taking off products, which means that the entire measuring complex completely, which reduces the length of time to prepare for the measurement; it is possible to adapt the product based on the size of the torso of the human body, provided repeated use of the product, tight fit, ease of construction through the use of wireless sensors.

Abstract

Le modèle d'utilité concerne les équipements médicaux et notamment un équipement pour la chirurgie cardiovasculaire et la cardiologie, et peut être utilisée pour le diagnostic et le traitement complexe par l'action sur le patient avec un rayonnement électromagnétique basse intensité lors de maladies cardiovasculaires, y compris en ligne et à distance. L'objectif visé par la réalisation du modèle présenté du gilet consiste à augmenter l'authenticité de la diagnostique de l'état du système cardiaque du patient et atteindre un degré d'universalité pour des patients de constitutions différentes grâce à un contact de qualité des électrodes avec le corps du patient. Pour mettre en oeuvre l'objectif visé le gilet comprend une partie d'épaule constituée de deux sangles de largeur égale et une partie corsage amovible qui comprend des électrodes, une unité de mesure de signaux sans fil, les électrodes étang intégrées dans la partie corsage, qui possède un dossier et un devant reliés en suivant des éléments superposés d'épaule et de flanc qui peuvent être complétés par un ensemble de pièces paires supplémentaires, qui possèdent une largeur pouvant être augmentée de façon discrète, la partie corsage étant conforme et réalisée à partir d'un matériau composite ; une première couche de matériau composite comporte des orifices pour accueillir les électrodes et l'unité de mesure de signaux, les ensembles d'électrodes se présentant comme des sections régulières, chaque électrode dans la section étant reliée au moyen de conducteurs à un microcontrôleur, une deuxième couche de matériau composite comprend une carte imprimée souple à laquelle sont branchés les microcontrôleurs, la sortie de la carte imprimée souple est reliée à l'unité de mesure de signaux, et une troisième couche de matériau composite est une couche de protection. La partie corsage du gilet peut en outre comporter dans la première couche des orifices pour capteurs sans fil tel que des photopléthysmogramme (PPG), des capteurs de température, etc. Lorsque l'application d'une action électromagnétique est nécessaire, une inductance magnétique peut se fixer par-dessus l'électrode.
PCT/RU2018/000504 2017-07-28 2018-07-27 Gilet pour examen électrophysiologique non invasif du coeur WO2019022646A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2017127215 2017-07-28
RU2017127215 2017-07-28

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WO2019022646A2 true WO2019022646A2 (fr) 2019-01-31
WO2019022646A3 WO2019022646A3 (fr) 2019-03-28

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2594335A (en) * 2020-04-20 2021-10-27 Prevayl Ltd Wearable article and method of making the same

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4608987A (en) * 1982-12-03 1986-09-02 Physioventures, Inc. Apparatus for transmitting ECG data
US5072458A (en) * 1987-05-07 1991-12-17 Capintec, Inc. Vest for use in an ambulatory physiological evaluation system including cardiac monitoring
AU2006235722A1 (en) * 2005-04-14 2006-10-19 Hidalgo Limited Apparatus and system for monitoring
GB2546065A (en) * 2015-11-27 2017-07-12 Mutant Craft Battle Wardrobe Ltd A garment

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2594335A (en) * 2020-04-20 2021-10-27 Prevayl Ltd Wearable article and method of making the same
GB2594335B (en) * 2020-04-20 2022-07-20 Prevayl Innovations Ltd Wearable article and method of making the same
US11937942B2 (en) 2020-04-20 2024-03-26 Prevayl Innovations Limited Wearable article and method of making the same

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