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WO2025212282A1 - Plot d'électrode multifonction à acquisition d'ecg à 12 dérivations intégrée - Google Patents

Plot d'électrode multifonction à acquisition d'ecg à 12 dérivations intégrée

Info

Publication number
WO2025212282A1
WO2025212282A1 PCT/US2025/020732 US2025020732W WO2025212282A1 WO 2025212282 A1 WO2025212282 A1 WO 2025212282A1 US 2025020732 W US2025020732 W US 2025020732W WO 2025212282 A1 WO2025212282 A1 WO 2025212282A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrode
pad
apex
sternum
defibrillation
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.)
Pending
Application number
PCT/US2025/020732
Other languages
English (en)
Inventor
Stephen Dunphy
Christian Mcclung
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.)
Cb Innovation LLC
Original Assignee
Cb Innovation LLC
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 Cb Innovation LLC filed Critical Cb Innovation LLC
Publication of WO2025212282A1 publication Critical patent/WO2025212282A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/046—Specially adapted for shock therapy, e.g. defibrillation
    • 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
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A61B5/259—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3904—External heart defibrillators [EHD]

Definitions

  • the present invention generally relates to ECG devices.
  • Defibrillation pads are an essential component of defibrillators and are used to deliver a shock to the heart in case of sudden cardiac arrest. Given the aging population, increase in comorbidities including but not limited to obesity, hypertension and diabetes, and an increase in the incidence of sudden cardiac death as well as atrial fibrillation is expected. The increase in atrial fibrillation incidence in the US population is being felt in the emergency department as well. The inventors note an increased personal experience in performing electrical cardioversion for atrial fibrillation. The use of disposable defibrillation pads is directly related to the incidence of sudden cardiac death/arrest and risk of arrythmia, such as atrial fibrillation, that are often treated with electrical cardioversion.
  • the device 20 is a multifunction electrode pad with integrated 12-lead ECG acquisition comprising of a sternum pad 18 and an apex pad 16.
  • the sternum pad 18 comprises a body 110 with a first defibrillation pad 30a and a first elongation section 25a.
  • the elongation section 25a comprises a first electrode member 27a with a first electrode 115a (VI), a second electrode member 27b with a second electrode 115b (V2), an expansion section 26a between the first electrode member 27a and the second electrode member 27b, and a third electrode 115c (RL).
  • the sternum pad 18 also has a right arm member 27c with a fourth electrode 115d (RA) and a line 28a to the body.
  • RA fourth electrode 115d
  • the apex pad 16 comprises a body 110 with a second defibrillation pad 30b and a second elongation section 25b.
  • the elongation section 25b comprises a third electrode member 27d with a fifth electrode 115e (V3), a fourth electrode member 27e with a sixth electrode 115f (V4), an expansion section 26b between the third electrode member 27d and the fourth electrode member 27e, a fifth electrode member 27f with a seventh electrode 115g (V5), another expansion section 26c between the fourth electrode member 27e and the fifth electrode member 27f, a sixth electrode member 27g with an eighth electrode 115h (V6), and another expansion section 26d between the fifth electrode member 27f and the sixth electrode member 27g.
  • the RA 115d, LA 115i, and LL 115j electrodes are on the back of the liner 32 (shown in FIGS. 17A, 20A), detaches from the pads 16, 18, and are applied to the proper locations (shown in FIGS 13-15).
  • the limb lead wire 28a-28c length is preferably 33 cm edge to edge (38 cm total including strips).
  • the device 20 is preferably composed of hydrogel, metal composites, an adhesive foam body, a release liner, lead wires, connector cables, a 12-lead EKG molded connector, and a defibrillation molded connector.
  • the molded connectors are preferably, clearly labeled.
  • the device 20 is preferably shielded and insulated.
  • the ECG electrodes are preferably 8-10 mm in diameter of silver chloride, AgCl.
  • the ECG electrodes are covered with hydrogel in diameter of 10-25 mm with a preferred thickness.
  • the ECG electrodes are preferably surrounded by adhesive material in a foam, or other soft substrate typical of defibrillation pads and other ECG electrodes.
  • the ECG electrodes are isolated from the defibrillation electrode pads 16, 18 physically by insulating material, preventing inadvertent conduction of defibrillation.
  • the ECG printed circuits are preferably 1-2 mm in width.
  • the ECG electrodes and circuits are made of flexible conductive inks that prevent fracture during chest compressions.
  • the ECG printed circuits have resistance of less than 2 ohms.
  • the device 20 in one embodiment comprises of placement markers 9, a polyester layer, wired circuits (printed silver tracing) 5, carbon contacts 4, an unwoven fabric layer, an AgCl components layer, an adhesive layer, a hydrogel components layer, and a backing liner layer.
  • a dielectric layer is not shown.
  • a 3-lead component 10 shown in FIGS. 23-24, allows for the 12-Lead ECG device to expand to a 15-lead ECG device.
  • the 3-lead component 10 comprises of a polyester layer 7, wired circuits (printed silver tracing) 5, carbon contacts, an AgCl components layer 2, an unwoven fabric layer 8, an adhesive layer 1, a hydrogel components layer 6, and a backing liner layer 3.
  • a dielectric layer is not shown.
  • An electrode allows for the acquisition of superficial electrical activity.
  • a wireless electrode interface carries the electrical activity to a transmitter or device directly.
  • a direct wired connector is a wire to an ECG machine interface, a multi-pin connector with or without amplification.
  • a conductive elastic rubber material is disclosed in U.S. Patent Number 8491884, which pertinent parts are hereby incorporated by reference.
  • a stretchable graphene film material is disclosed in Chen et al., U.S. Patent Publication Number 20150273737, which pertinent parts are hereby incorporated by reference.
  • the product is intended to be used by trained medical personnel (paramedics, nurses, doctors, etc.) and, if connected to automated external defibrillators (AEDs), by untrained laypersons.
  • the device is intended for single patient use, is disposable, is sold non-sterile, and is packaged in a hermetically sealed pouch.
  • the device is available in 3 forms: Adult Composite 12-lead MultiFunction Defibrillation Electrode Pad; Pediatric Composite 12-lead MultiFunction Defibrillation Electrode Pad; and Infant Composite 12-lead MultiFunction Defibrillation Electrode Pad.
  • the device preferably adheres to a patient for at least 8 hours.
  • the device packaging will be marked with specific tear-open locations.
  • the device labeling will clearly demonstrate proper positioning of the multifunction pads and proper positioning of the cardiac ECG electrodes.
  • the device labeling preferably includes a marker for V4 with mid clavicular notation, a marker for V6 with mid axillary notation, and markers for placement of VI and V2.
  • the device preferably clearly labels the extremity locations with RA for right upper extremity, LA for left upper extremity, and LL for left lower extremity.
  • the device shall clearly label the extremity locations with RUE for right upper extremity, LUE for left upper extremity, and LLE for left lower extremity.
  • the device can remain in place during cardiopulmonary resuscitation (CPR)/chest compressions for up to 30 minutes.
  • CPR cardiopulmonary resuscitation
  • the device electrode cables and printed wires preferably can tolerate chest compressions/CPR for up to 30 minutes.
  • the adult device preferably accommodates 5 ⁇ percentile to 95 ⁇ percentile sized adult patients.
  • the infant device is intended for infants and children under 1 years of age.
  • the pediatric device is intended for pediatric patients.
  • the device is preferably compliant with ANSI AAMI ECU, EC12, EC53 and IEC 60601-2-4.
  • the device is preferably compliant to ISO 10993 biocompatibility standards and ISTA2 standards.
  • the device can preferably be stored at 15-35 degrees Celsius and have an unopened shelflife of 24 months.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un plot d'électrode multifonction avec un dispositif d'acquisition d'ECG à 12 dérivations intégré (20). Les électrodes (115) sont incorporées dans les deux plots d'électrode de défibrillation (16 et 18). Chacun du plot de défibrillation de sternum (18) et du plot de défibrillation d'apex (16) est composé d'une plaque conductrice électrique dans un substrat en ruban de mousse avec une couche d'hydrogel. Chacun du plot de sternum (18) et du plot d'apex (16) a une surface conductrice de plot d'électrode de défibrillation qui a une surface dont la superficie varie de 80cm3 à 90cm3.
PCT/US2025/020732 2024-04-03 2025-03-20 Plot d'électrode multifonction à acquisition d'ecg à 12 dérivations intégrée Pending WO2025212282A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463573462P 2024-04-03 2024-04-03
US63/573,462 2024-04-03

Publications (1)

Publication Number Publication Date
WO2025212282A1 true WO2025212282A1 (fr) 2025-10-09

Family

ID=97268021

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/020732 Pending WO2025212282A1 (fr) 2024-04-03 2025-03-20 Plot d'électrode multifonction à acquisition d'ecg à 12 dérivations intégrée

Country Status (1)

Country Link
WO (1) WO2025212282A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040176674A1 (en) * 2003-03-04 2004-09-09 Alireza Nazeri EKG recording accessory system (EKG RAS)
US6847836B1 (en) * 2002-02-08 2005-01-25 Lenny Sujdak Emergency ECG electrode chest pad
WO2008120154A2 (fr) * 2007-03-30 2008-10-09 Hendrik Lambert Koekemoer Dispositif précordial
US20100324612A1 (en) * 2003-06-11 2010-12-23 Matos Jeffrey A System for cardiac resuscitation
US20140364918A1 (en) * 1997-03-07 2014-12-11 Cardiac Science Corporation Defibrillation system
US20170056682A1 (en) * 2014-02-24 2017-03-02 Element Science, Inc. External defibrillator
US11864858B1 (en) * 2017-03-01 2024-01-09 CB Innovations, LLC Emergency cardiac and electrocardiogram electrode system with wireless electrodes
US20240057918A1 (en) * 2017-03-01 2024-02-22 CB Innovations, LLC Electrocardiogram Apparatus

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140364918A1 (en) * 1997-03-07 2014-12-11 Cardiac Science Corporation Defibrillation system
US6847836B1 (en) * 2002-02-08 2005-01-25 Lenny Sujdak Emergency ECG electrode chest pad
US20040176674A1 (en) * 2003-03-04 2004-09-09 Alireza Nazeri EKG recording accessory system (EKG RAS)
US20100324612A1 (en) * 2003-06-11 2010-12-23 Matos Jeffrey A System for cardiac resuscitation
WO2008120154A2 (fr) * 2007-03-30 2008-10-09 Hendrik Lambert Koekemoer Dispositif précordial
US20170056682A1 (en) * 2014-02-24 2017-03-02 Element Science, Inc. External defibrillator
US11864858B1 (en) * 2017-03-01 2024-01-09 CB Innovations, LLC Emergency cardiac and electrocardiogram electrode system with wireless electrodes
US20240057918A1 (en) * 2017-03-01 2024-02-22 CB Innovations, LLC Electrocardiogram Apparatus

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