WO2023166533A1 - Système de surveillance d'ecg pouvant être porté intelligent et procédé associé - Google Patents

Système de surveillance d'ecg pouvant être porté intelligent et procédé associé Download PDF

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Publication number
WO2023166533A1
WO2023166533A1 PCT/IN2023/050208 IN2023050208W WO2023166533A1 WO 2023166533 A1 WO2023166533 A1 WO 2023166533A1 IN 2023050208 W IN2023050208 W IN 2023050208W WO 2023166533 A1 WO2023166533 A1 WO 2023166533A1
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WO
WIPO (PCT)
Prior art keywords
belt
ecg
electrodes
user
wearable
Prior art date
Application number
PCT/IN2023/050208
Other languages
English (en)
Inventor
Srushti Vora ADANI
Ankit VYAS
Original Assignee
Adani Srushti Vora
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 Adani Srushti Vora filed Critical Adani Srushti Vora
Publication of WO2023166533A1 publication Critical patent/WO2023166533A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/332—Portable devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/256—Wearable electrodes, e.g. having straps or bands
    • 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
    • A61B5/6801—Arrangements 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
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses

Definitions

  • the present invention relates to a smart wearable ECG monitoring system and method thereof.
  • the invention relates to a smart wearable ECG monitoring system and method that includes a self-administrable ECG-belt which can be utilized even at home-level.
  • a medical-grade 12-lead ECG is measured using 10-Leads i.e. VI, V2, V3, V4, V5, V6, RA, LA, RL, LL.
  • a general ECG measuring system is illustrated in Figure la. It has various electrodes placed on the body of the user.
  • ten electrodes in a 12-lead ECG may comprise RA (101) on the right arm, avoiding thick muscle; LA(102) in the same location where RA is placed on upper side of the left arm in a traditional case; RL(103) on the upper side of the right leg, the lower end of medial aspect of calf muscle; LL (104) in the same location where RL is placed, but on the left leg; VI (105) in the fourth intercostal space just to the right of the sternum (breastbone); V2 (106) in the fourth intercostal space just to the left of the sternum.
  • a US granted patent US8954129B1 provides an electrode wearable or harness permits for easy, quick, and unsupervised administration or self-administration of a resting 12-or-more-lead ECG.
  • the disclosure claims various advantageous features of the electrode wearable or harness include: inflatable or padded cushions at the lateral sides of the torso that function to press LA and RA electrodes mounted on the cushions against the downward-resting arms of the subject, permitting good electrode abutment with distal electrode placement without the need for adhesives, straps, bands, bracelets, or gloves on the arms; padding over the sternum to avoid tenting in the VI, V2, V3 and V3R electrodes whenever present, easy-to-don, one-piece design with an adjustable single point of connection and an adjustable shoulder strap; Lund or modified Lund placement; dry electrodes; and various other features.
  • Methods of use are also described. However, the belt and the method may be cumbersome and not allow user an accurate indication of electrode misplacement. Also the ruggedness of the system may be insufficient.
  • the wearable or garment includes at least one substantially non-electrically conductive stretch-recovery yarn and at least three conductive electrodes of, for example, stretch-recovery electrically conductive yarns integrated with the wearable device.
  • Also included in the wearable systems is at least one means for conducting electrical signals associated with at least one physiological event or physiological characteristic of the wearer from the garment to an external means.
  • the external means can, for example, be used to signal pre-process, preamplify, amplify, process, display, filter, analyze, alarm and/or store electrical signals associated with at least one physiological event or physiological characteristic of the wearer.
  • use by various body shapes and ease and indication of correct placement of various electrodes may not be accurately provided.
  • the present invention provides a wearable ECG belt comprising: a. a belt to be worn around chest of a user housing VI, V2, V3, V4, V5, V6 and RL electrodes; b. an arm portion of said belt comprising two electrodes RA (210) and LA (211); c. a neck strap configured to worn behind the neck and attach with the said arm portion of said belt in the front of the chest of the user.
  • the present invention provides the wearable ECG belt the RA and LA electrodes are in close proximity to clavical or manubrium portion of the chest, measuring a 12 lead medical grade ECG data using 10 lead.
  • the present invention provides that the wearable ECG belt further comprising a fastening arrangement configured to lock the said belt around the chest of a user and allow for adjustment of tightness thereof; a size adjusting mechanism attached to said neck strap.
  • the present invention provides that the wearable ECG belt the stretchable material of the belt is configured to comport to a user's physical shape when the fastening arrangement is tightened. Further, in another embodiment, the wearable ECG belt, the material of the belt is one or more of Neoprene, Lycra, Silicon, Rubber Sheet, and Elastic.
  • the wearable ECG belt further comprising, an electronic assembly attached to the said belt in close proximity to the chest region of the user; an Electronic ECG monitoring unit configured to intermittently check for correct placement of all electrodes; an Electronic communication unit configured to communicate the measured values to a user interface.
  • the present invention provides for a method for measuring a 12 lead medical grade ECG data using 10 lead comprising the steps of: a. Checking 501 of correct placement of the belt using an onboard electronic assembly attached to said electrodes; b. providing 503 an indication to the user of the correct or incorrect placement of the various electrodes; c. prompting for corrective action until correct placement is achieved; d. fetching 505 of, the ECG data; e. displaying user ECG data.
  • the method comprises the step of providing an indication for correct or incorrect placement of an electrode RA and an electrode LA.
  • An embodiment further comprising the step of providing 503b a separate indication for correct placement of LL electrode 213.
  • the present invention provides the method as further comprising the step of sending the captured ECG data to a smart device.
  • the present invention provides for the method comprising, displaying an indication of identified illness.
  • the main objective of the invention is to provide a smart wearable ECG monitoring system comprising a plurality of units and modules and the method includes a plurality of steps.
  • Another objective of the invention is to provide a smart wearable ECG monitoring system including a self-administrable ECG-belt which has a self-wearable design and can be utilized at the home level.
  • Another objective of the invention is to provide a smart wearable ECG monitoring system including a self-administrable ECG-belt which has a universal size.
  • Another objective of the invention is to provide a smart wearable ECG monitoring system that includes a belt having electrodes i.e. VI, V2, V3, V4, V5, V6, RA, LA, and RL at specific locations to avoid any misplacement.
  • Another objective of the invention is to provide a wearable neck portion of the belt wherein two electrodes are positioned.
  • Yet another objective of the invention is to provide a LL electrode, which is attached to the ECG monitoring belt using a wire.
  • Another objective of the invention is to provide a method of monitoring that includes a plurality of steps to monitor medical-grade 12-Lead ECG data which can be shared with the correspondent doctor via a smartphone app, SMS, email, etc.
  • Figure la illustrates the general ECG measuring system having various electrodes placed on the body of the user.
  • Figure lb illustrates schematically the ECG measuring system having various electrodes placed on the body of the user as per an embodiment herein.
  • Figure lc illustrates a representative block diagram of the ECG measuring system as per an embodiment herein.
  • Figure 2 illustrates the top view of a smart wearable ECG monitoring system includes a belt having electrodes as per an embodiment herein.
  • Figure 3 illustrates the bottom view of the smart wearable ECG monitoring system includes a belt having a plurality of electrodes as per an embodiment herein.
  • Figure 4a and 4b illustrates a smart wearable ECG monitoring system that includes a neck belt strap, which may be attached to the belt as per an embodiment herein worn by a male and female user respectively.
  • Figure 5 illustrates a method of smart ECG monitoring that includes a plurality of steps to capture and transmit the ECG data to the display device as per an embodiment herein.
  • the referral numerals in the figures refer to: in the backgroud Figure la, (101)- RA; (102) - LA; (103) - RL; (104) - LL; (105) - VI; (106) - V2; (107) - V3; (108) - V4; (109) - V5; (110) - V6;Rest of the figures: (200) - smart ECG monitoring system; (200A) - ECG monitoring belt; 201 -supporting strap; 202, 203, 204, 205 -fastening arrangement; (206) - Electronic assembly; (207) - a wire; (208) - user; (209) - ECG data; (210)- RA; (211) - LA; (212) - RL; (213) - LL; (214) - VI; (215) - V2; (216) - V3; (217) - V4; (218) - V5; (219) - V6; (2
  • references in the specification to “one embodiment” or “an embodiment” means that a particular feature, structure, characteristic, or function described in connection with the embodiment is included in at least one embodiment of the invention.
  • the appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.
  • the headings and subheadings used in the document are not intended to limit the content therein to the respective heading or subheading. Rather, they are used to help readers navigate and prevent obscuring the invention.
  • Figure lb illustrates schematically the ECG measuring system having various electrodes placed on the body of the user as per an embodiment herein.
  • the ground electrode placed on the right leg by convention, may be positioned anywhere on the body without affecting the ECG waveforms. However, if it is erroneously positioned on an arm and if an arm electrode is therefore positioned on the right leg, a characteristic alteration of the electrocardiogram occurs.
  • RL may be placed anywhere on the body without affecting waveform.
  • FIG. lc illustrates a representative block diagram of the ECG measuring system as per an embodiment herein.
  • the system may comprise 10 electrodes 211a, 212a, 213a, 214a, 215a, 216a, 217a, 218a, 219a.
  • the 10 electrodes may be communicatively coupled to an Electronic ECG monitoring unit EEMU 220 also referred to as EEMU.
  • EEMU Electronic ECG monitoring unit
  • the EEMU may be present in a belt portion of the system, while in another embodiment the EEMU may be made present as a standalone unit.
  • EEMU may form part of a mobile or tablet or another computing system that may house the EEMU.
  • the EEMU may be configured to check for correct placement of the belt. This checking may be done by sending test pulses and analyzing said results with pre stored data therein.
  • the EEMU may be part of the electronic assembly 206.
  • a communication unit 221 also referred to as Electronic communication unit or an ECU may be provided coupled to the EEMU 220. This connection may be wired or wireless.
  • the ECU may be made available in a belt portion of the system.
  • the ECU may be made available as a standalone unit, where the EEMU is made available as well.
  • this may form part of a mobile or tablet or another computing system that may house the EEMU as well.
  • the ECU may be configured to communicate the measured ECG values to a user interface.
  • This interface 280 may be provided on a remote computing or mobile device.
  • the smart wearable ECG monitoring system (200) includes a belt (200A). As illustrated in Figure 2, said belt (200A) is wearable on the chest and neck portion of the user's (208) body as per an embodiment herein.
  • the belt (200A) has a fastening arrangement 202, 203, 204, 205. This may allow the user (208) to adjust the belt (200A) size according to the size suitable for the user (208).
  • the fastening arrangement may be in the form of a Velcro arrangement, a buckle, and a strap, or the like. All electrodes other than the RA, LA and LL electrodes may be provided in the main portion of the belt.
  • a neck strap (201) comprising two electrodes RA (210) and LA (211) may be provided to be worn so as to go behind the neck and attach with the arm portion of the belt, comprising the RA and LA electrodes 210 and 211. These RA and LA electrodes may be close to clavical or manubrium portion of the chest.
  • the neck strap (201) may be worn around the neck and connected to the belt (200A)at the electronic assembly 206.
  • the material used for the belt may be stretchable. Materials such as for example Neoprene, Lycra, Silicon, Rubber Sheet, Elastic may be used. The stretchability of the material further allows the belt to comport to a user's physical shape when the fastening arrangement is tightened.
  • a size adjusting mechanism may be provided in the said neck portion. Since the material of the belt is stretchable it allows for increasing the distance between various electrodes. For example when the neck portion of the belt is tightened the distance between the 215 electrode and the 210 electrode increases. Further, if the buckle pair 202 and 203 is locked and tightened the distances between various electrodes 217, 218, 219, 212 may increase. In one embodiment the material used in the protion of the neck strap 201 that houses 210, 211, (RA and LA) may be different than that used in the portion that goes behind the neck. In one embodiment the neck portion of the strap may be of a stretchable fabric material while that housing the electrodes 210 and 211 (RA and LA) may be PVC or silicone/neoprene.
  • the electronic assembly (206) may provide a plurality of electrodes.
  • the EEMU is part of the belt assembly.
  • the EEMU (220) may also provide a slot for charging cable such as for example USB.
  • a power button may also be provided.
  • a smart wearable ECG monitoring system (200) includes belt (200A) having electrodes i.e. VI (214), V2 (215), V3 (216), V4 (217), V5 (218), V6 (219), RA (210), LA (211) and RL (212) at specific locations.
  • Two electrodes are positioned on the wearable neck portion of the belt.
  • a LL (213) electrode is attached to the ECG monitoring belt (200 A) using an LL electrode wire (207). This wire may be flexible and stretchable as well. All the electrodes are connected to an ECG monitoring electronic system (200) may be powered by an internal battery or external source.
  • RL(212) can be anywhere on the body as it is acting like a ground electrode. In one embodiment the same is placed on the right side below the chest on the belt design (Can be compared with Figure- 1 212).
  • Figure 4a and 4b illustrates a smart wearable ECG monitoring system that includes a neck belt strap, which may be attached to the belt as per an embodiment herein worn by a male and female user respectively.
  • the user (208) may wear the ECG belt (200A) and place the loosely placed LL (213) electrode anywhere on the Left-Leg.
  • a method of smart ECG monitoring including a plurality of steps that includes the first smart ECG bet (200A) is worn by the user (208).
  • Checking 501 of correct placement of the belt may take place. This checking may be done by sending test pulses and analyzing said results with pre stored data.
  • providing 503a an indication separately for electrodes 210 and 211 (RA and LA) may take place.
  • Providing 503b a separate indication for correct placement of LL electrode 213 may take place.
  • Fetching 505 of the the ECG data may take place through the electronic assembly (206) comprising EEMU (220) and communication unit (221). Further step may comprise sending the captured ECG data (209) using a communication unit (221) over the network to the mobile or other smart device. Finally data is visible on the display of the connecting device. The analysis of the data at a mobile/computing unit may then take place. The historical data along with current data may be provided in form of a report. Also, exemplary indications of illnesses may be provided.
  • An embodiment provides a system (200) including a belt (200A) comprising electronic assembly (206), as illustrated in Figure 2.
  • the belt (200A) has an electronic ECG data monitoring unit EEMU (220) and communication unit (221).
  • the electrodes that help in capturing ECG data (209) and one communication unit (221) that helps in sending the captured ECG data (209) to the mobile or computer using Bluetooth or WIFI.
  • the invention provides a belt (200A) having electrodes i.e. VI (214), V2 (215), V3 (216), V4 (217), V5 (218), V6 (219), RA (210), LA (211) and RL (212) at specific locations to avoid any misplacement as illustrated in Figure 3.
  • two electrodes are positioned on the wearable neck portion of the belt.
  • a LL (213) electrode is attached to the ECG monitoring belt (200A) using an LL electrode wire (207).
  • the invention also provides a supporting neck strap (201) comprising two electrodes RA (210) and LA (211). Wherein, the strap (201) is worn around the neck and connected to the belt (200A).
  • RL(212) can be anywhere on the body as it is acting like a ground electrode. In one embodiment the same is placed on the right side below the chest on the belt design (Can be compared with Figure-1 212).
  • the invention provides a belt (200A), as illustrated in Figure 4a and 4b.
  • Said belt (201) is wearable on the chest and neck portion of the user (208) body.
  • the belt (200 A) has fastening arrangement 202, 203, 204, 205. This may allow the user (208) to adjust the belt (200A) size according to the size suitable for the user (208).
  • the fastening arrangement may be in the form of a Velcro arrangement, a buckle, and a strap or the like. More specirfically, in an embodiment, the 202 and 203 may form the buckle pair.
  • the shape of the belt (200A) is comfortable and easily wearable and provides all electrodes a particular position to capture the ECG data. The user (208) can operate it in an easy way.
  • the invention provides a system (200) that may comprise various ECG electrodes that are in contact with various ECG points of the body using a belt (200A).
  • the belt (200A) has an electronic assembly (206) comprising a signal capture module, an amplifier, an analog to digital converter (ADC) are the part of electronic ECG data monitoring unit EEMU (220) and ECG data interpretation module and indicative output module are part of electronic communication unit (221).
  • a signal capture module captures the data sent by the ECG electrodes.
  • An amplifier may be provided to amplify the signal.
  • An analog to digital converter (ADC) may be provided for the conversion of the amplified signal into digital ECG data.
  • Said digital ECG data may be interpreted at a central server system that may be in interaction with a database that houses historic as well as current data for data interpretation.
  • the ECG data interpretation module may be present that directly receives the digital ECG data for local interpretation of data.
  • An indicative output module may be present that receives data from the ECG data interpretation service module for providing indicative outputs to the user including the normality/abnormality noted in the ECG.
  • Said ECG data may be in the form of a report available on the display of the screen of the data receiving device.
  • the invention may also solve problems (but not limited to) such as correct placement of ECG, also may add on easy access to an ECG due to portability and ease of use and therefore, reducing symptom to needle time in emergency cardiac events. Furthermore, applicability of the same belt to various body types is further enhanced by use of stretchable material in the belt.
  • the system (200) includes medical grade 12-Lead ECG Belt (200A) and has applications at Homes, Offices, Factories, School, Universities, Clinics, Hospitals, and every single place where there is a possibility of cardiac emergency.
  • the belt design is self-wearable. The user can easily wear it.
  • the belt design has a universal size that changes through the sliding belt mechanism as the user's body. As per the belt assembly design, the electrode misplacement is avoided.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Cardiology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne un système de surveillance d'ECG pouvant être porté intelligent et un procédé associé, un système de surveillance d'ECG pouvant être porté intelligent (200) comprenant une ceinture ECG auto-administrable (200A) qui a une conception auto-portable et peut être utilisée au niveau domestique. Le système (200) comprend une ceinture ECG auto-administrable (200A) qui a une taille universelle. Ladite ceinture (200A) a une unité de surveillance de données d'ECG électronique (220) et une unité de communication (221). Les électrodes qui aident à capturer des données ECG (209) et une unité de communication (221) aide à envoyer les données ECG capturées (209) au mobile ou à l'ordinateur en utilisant Bluetooth ou WIFI. Ladite ceinture (200A) comporte également une partie col pouvant être portée, deux électrodes étant positionnées. L'invention concerne également un procédé de surveillance qui comprend une pluralité d'étapes pour surveiller des données d'ECG à 12 dérivations de qualité médicale (209) qui peuvent être partagées avec le médecin concerné par l'intermédiaire d'une application de téléphone intelligent, SMS, courrier électronique, etc.
PCT/IN2023/050208 2022-03-04 2023-03-06 Système de surveillance d'ecg pouvant être porté intelligent et procédé associé WO2023166533A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202121041039 2022-03-04
IN202121041039 2022-03-04

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WO2023166533A1 true WO2023166533A1 (fr) 2023-09-07

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8527028B2 (en) * 2007-05-16 2013-09-03 Medicomp, Inc. Harness with sensors
JP6114501B2 (ja) * 2011-03-31 2017-04-12 アディダス アーゲー センサ衣服

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8527028B2 (en) * 2007-05-16 2013-09-03 Medicomp, Inc. Harness with sensors
JP6114501B2 (ja) * 2011-03-31 2017-04-12 アディダス アーゲー センサ衣服

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