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WO2016052777A1 - Dispositif de mesure de signaux bioélectriques - Google Patents

Dispositif de mesure de signaux bioélectriques Download PDF

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Publication number
WO2016052777A1
WO2016052777A1 PCT/KR2014/009253 KR2014009253W WO2016052777A1 WO 2016052777 A1 WO2016052777 A1 WO 2016052777A1 KR 2014009253 W KR2014009253 W KR 2014009253W WO 2016052777 A1 WO2016052777 A1 WO 2016052777A1
Authority
WO
WIPO (PCT)
Prior art keywords
measuring device
signal measuring
transmitter
bioelectrical signal
human body
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.)
Ceased
Application number
PCT/KR2014/009253
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English (en)
Korean (ko)
Inventor
박경석
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.)
SNU R&DB Foundation
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SNU R&DB Foundation
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 SNU R&DB Foundation filed Critical SNU R&DB Foundation
Priority to PCT/KR2014/009253 priority Critical patent/WO2016052777A1/fr
Publication of WO2016052777A1 publication Critical patent/WO2016052777A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • 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
    • 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
    • A61B5/389—Electromyography [EMG]

Definitions

  • the present invention relates to a wireless bioelectric signal measuring apparatus capable of measuring a bioelectrical signal in contact with muscles or nerves in the human body, and in particular, an opening or cavity of the human body including the larynx for monitoring the nervous system during surgery.
  • the present invention relates to an apparatus for measuring and transmitting a bioelectrical signal of a wirelessly.
  • Intraoperative Neurophysiologic Monitoring is used extensively in neurological surgery to help detect early damage to the nervous system during surgery, reduce postoperative complications, and help to safely perform high-risk surgery.
  • Intraoperative nervous system monitoring is mainly a method of monitoring the abnormality of the nervous system during the operation using the electrophysiological method. Electrophysiological methods are using EEG, induced potential, and EMG. (Induced Potential Test in Surgery of the Nervous System During Surgery, Seo Dae-won, Korean Journal of Clinical Neurophysiology 9, 2, 2007).
  • Endotracheal tubes are used as a common method of airway management in most general anesthesia.
  • Endotracheal tube is a tube that is inserted into the airway for ventilation during surgery.
  • the purpose of endotracheal intubation to insert the endotracheal tube into the human body is low ventilation (a state in which carbon dioxide is not properly discharged through respiration), hypoxia, aspiration in the trachea (gastric or esophagus, or mouth discharge). To the respiratory tract).
  • Korean Patent Laid-Open Publication No. 2012-0087933 relates to an “endobronchial device”, wherein a bioelectric signal measuring device is integrally attached to an outer circumferential surface of the endotracheal tube, and the electrodes of the measuring device come into contact with the vocal cords of the patient during surgery. Almost measure bioelectrical signals.
  • an electrode When an electrode is placed in the patient's airway, it is configured to receive an EMG (Electromyography) signal from the Larygeal muscles.
  • EMG Electromyography
  • the conventional technique in which the bioelectrical signal measuring device is integrally connected to the endotracheal tube is a surface electrode of the bioelectrical signal measuring device mounted on the outer peripheral surface of the endotracheal tube through a long outer wire which extends from the endotracheal tube portion exposed to the patient's body during surgery. Record the bioelectrical signal by connecting the external receiver with the wire.
  • These prior art externally connected wires are limited in their length, which limits their use distance, and may prevent the wires from obstructing the doctor's field of view or obstructing the operation of the surgical instruments during operation. It may be dangerous.
  • the present application has been made to solve the above problems, by selecting the electrical signal detection unit of the bioelectrical signal measuring device as an electrode structure having a wireless transmitter, the detection unit of the internal tube (internal body catheter or human body conduit) and the By removing the wires between the display unit to receive and display the signal detected by the detection unit, to free the position of the bioelectrical signal display unit as well as to improve the disadvantages of the prior art, such as constraints on the field of view or obstruction of the operation of the surgical instruments due to the wire.
  • the present invention has been completed by allowing the bioelectrical signal measuring apparatus to be attachable to an internal human body apparatus and to have a wireless transmission function.
  • the insulating film attachable to the outer peripheral surface of the inner tube inserted into the opening of the human body; A plurality of thin film electrodes arranged to be in contact with a muscle or nerve part at which a portion of the human body tube is located; A transmitter for wirelessly transmitting a bioelectric signal detected by the thin film electrode; A conductive wire electrically connecting the thin film electrode and the transmitter; And a battery for operating the transmitter, wherein the electrode, the transmitter, the conducting wire, and the battery are disposed on the insulating film.
  • the present invention also provides a bioelectrical signal measuring apparatus, wherein the hole of the human body is trachea.
  • the present invention also provides a bioelectrical signal measuring apparatus, wherein the hole of the human body is the anus or urethra.
  • the present invention also provides a bioelectrical signal measuring apparatus having a plurality of thin film electrodes and printed with conductive ink.
  • the present invention also provides a bioelectrical signal measuring apparatus, wherein the insulating film is made of a flexible printed circuit board.
  • the present invention also provides a bioelectric signal measuring apparatus of which the material of the flexible printed circuit board is PET (Polyethylene Telephthalate), PEN (Polyethylene Naphthalate) or PI (Polyimide).
  • PET Polyethylene Telephthalate
  • PEN Polyethylene Naphthalate
  • PI Polyimide
  • the present invention also provides a bioelectric signal measuring apparatus, wherein the applied muscle of the measuring device is the larynx muscle (including the vocal cord muscle), the anal sphincter, or the urethral sphincter.
  • the present invention also provides a bioelectrical signal measuring device, wherein the applied nerve of the measuring device is a laryngeal nerve (including a reversing laryngeal nerve) or a genital nerve.
  • the applied nerve of the measuring device is a laryngeal nerve (including a reversing laryngeal nerve) or a genital nerve.
  • the present invention also provides a bioelectrical signal measuring apparatus, wherein the battery for operating the transmitter is a lithium battery.
  • the present invention also provides a bioelectrical signal measuring apparatus further comprising a receiving and displaying unit for receiving and displaying a bioelectrical signal from the transmitter.
  • the present invention also comprises an insulating film comprising a head having a wide area and a tail portion connected to the head and attachable along a length of an internal tube inserted into the human body; A plurality of thin film electrodes positioned in the head portion opposite to the insulating film surface to be attached to the human body tube, and arranged to contact a muscle or nerve part where one portion of the human body tube is located; And positioned at the tail portion of the insulating film, one end is electrically connected to the thin film electrode, the other end includes a conductive wire leading to the end of the tail, provides a bioelectric signal measuring apparatus.
  • the present invention also provides a bioelectrical signal measuring apparatus having a plurality of thin film electrodes and printed with conductive ink.
  • the present invention also provides a bioelectric signal measuring apparatus, wherein the applied muscle portion of the measuring device is the larynx muscle (including the vocal cord muscle), the anal sphincter, or the urethral sphincter.
  • the present invention also provides a bioelectrical signal measuring device, wherein the applied nerve of the measuring device is a laryngeal nerve (including a reversing laryngeal nerve) or a genital nerve.
  • the applied nerve of the measuring device is a laryngeal nerve (including a reversing laryngeal nerve) or a genital nerve.
  • the present invention also provides a bioelectrical signal measuring apparatus in which the conductive wire is insulated and coated with an electrical conductor tape on one side of the tail portion.
  • the present invention also provides a bioelectric signal measuring apparatus in which the conductive wire is printed with conductive ink on one side of the tail and then coated.
  • the present invention also includes a transmitter connected to the endotracheal tube which is not inserted into the human body and protrudes out of the body; It further comprises a reception and display unit for receiving and displaying the bioelectrical signal from the transmitter, bio-electrical signal measuring apparatus.
  • the bioelectrical signal measuring apparatus of the present invention transmits the detected bioelectrical signal to the display unit by using a wireless transmitter, thereby releasing the bioelectrical signal display unit from the positional limitation due to the wire, restricting the operation field due to the wire, or disturbing the operation of the surgical instrument. Providing a surgical environment that does not exist.
  • FIG. 1 is a reference diagram of an endotracheal tube integrated bioelectrical signal measuring apparatus according to the prior art.
  • FIG. 2 is a conceptual diagram of a bioelectrical signal measuring apparatus 1 including a wireless transmitter, which may be attached to an outer circumferential surface of an endotracheal tube.
  • FIG. 3 is a cross-sectional view of a portion connecting A-A 'of FIG.
  • FIG. 4 is a conceptual diagram of an endotracheal tube to which the bioelectrical signal measuring apparatus 1 of FIG. 2 is attached.
  • FIG. 5 is a conceptual diagram of a bioelectrical signal measuring apparatus 2 that can be attached to an outer circumferential surface of an endotracheal tube.
  • FIG. 6 is a cross-sectional view of a portion connecting BB ′ of FIG. 5.
  • FIG. 7 is a conceptual diagram of an endotracheal tube to which the bioelectrical signal measuring apparatus 2 of FIG. 5 is attached.
  • the bioelectrical signal measuring apparatus of the present invention is applicable to a hole of a human body such as an organ, anus, and urethra. It will be described below in detail by focusing on the endotracheal tube device for monitoring the function of the recurrent laryngeal nerve by measuring in the larynx muscle including the vocal cord muscle inserted into the trachea.
  • the endotracheal tube includes a beveled tip (100), a cuff (200), a pilot balloon (400), an inflating tube (500), and a connector (600). do.
  • the beveled tip 100 has an inclination angle to facilitate insertion of the inner tube into the airway during tracheal intubation in which the endotracheal tube is inserted into the body.
  • the cuff 200 is attached to one end in the direction of insertion into the human body of the endotracheal tube.
  • the air sac expands when an appropriate amount of air is introduced after endotracheal intubation to block the space between the outer wall of the endotracheal tube and the mucous membrane of the trachea, thereby preventing the air blown into the ventilator from leaking out of the respiratory tract, and sucking the contents of the oral cavity or larynx. Prevents complications such as pneumonia.
  • the pilot balloon (Pilot balloon) 400 is connected to the bladder to check the pressure of the bladder during surgery. Too high pressure causes ischemia in the airway, airway esophagus (phenomena connected with the esophagus), and tracheal narrowing. Too low pressure can cause the endotracheal tube to escape.
  • the inflating tube 500 connects between the bladder and the pilot balloon, and passes the pilot balloon from the outside to inject air into the bladder.
  • the connector 600 is connected to a ventilator.
  • An electrode 300 capable of measuring a bioelectrical signal, which is a signal in the form of a current or voltage generated by muscles or nerve cells, on the outer wall of the endotracheal tube, and receiving and displaying the bioelectrical signal measured by the electrode Consists of a connecting portion 700 which is a conductive line connecting the receiving unit and the display unit (not shown) with the electrode.
  • a bioelectrical signal which is a signal in the form of a current or voltage generated by muscles or nerve cells
  • bioelectrical signal measuring device integrated endotracheal tube By inserting the bioelectrical signal measuring device integrated endotracheal tube into the human body during surgery, it prevents hypoventilation, hypoxia, aspiration in the trachea, and measures the bioelectrical signal through electrodes in contact with the vocal cord muscles or nerves during surgery. To help safe surgery.
  • the integrated device attempts to overcome these limitations through a wireless transceiver because of the problem of the surgeon's field of view, space constraints, etc. due to the connection portion 700.
  • the present invention separates the bioelectrical signal measuring device from the endotracheal tube.
  • the measuring device is capable of wireless transmission and can be attached to the outer peripheral surface of the endotracheal tube.
  • the bioelectrical signal measuring apparatus of the present invention is shown in FIG. 2.
  • the measuring device includes a thin film electrode 11, a transmitter 12, and a battery 13 on an insulating film 10 having an adhesive part 14 so as to be attached to an outer circumferential surface of the endotracheal tube. do.
  • the electrode 11 is arranged on the surface opposite to the adhesive portion of the insulating film so as to contact the muscle or nerve portion where one portion of the endotracheal tube is located.
  • the transmitter 12 wirelessly transmits a bioelectric signal detected by the thin film electrode, and therein, an individual element such as an oscillator, an amplifier, an antenna, a switch, etc., uses an ultra-small semiconductor application specific integrated circuit (ASIC) chip. It may include any one of those known in the art.
  • ASIC semiconductor application specific integrated circuit
  • the electrode for detecting the bioelectrical signal in contact with the muscle or nerve part may be a metal, alloy, or non-metallic conductor which can be inserted into the human body, and has a low electrical resistance to detect the bioelectrical signal in contact with the human muscle. Conductors can be used.
  • the plurality of thin film electrodes 11 may be used by printing with conductive ink on an insulating film.
  • the conductive ink may be used as long as it has high conductivity such as conductive metal ink, conductive carbon ink or conductive polymer ink.
  • the battery 13 for operating the transmitter 12 may use a lithium battery having high internal stability.
  • the lithium battery is a battery using lithium or a lithium mixture as a negative electrode, a cardiac pacemaker because the operating time is long and has an output voltage twice as large as that of manganese or alkaline batteries, and there is no leakage of the battery when using a solid electrolyte. It is inserted into the human body and used for driving.
  • the adhesive part 14 is positioned on the lower surface of the insulating film 10, and the electrode 11 is exposed to the upper surface so that the bioelectrical signal can be measured.
  • the insulating film has excellent workability, excellent thermal and chemical resistance, low dimensional change, strong heat, and good flexibility, and is easy to attach to the outer circumferential surface of the inner tube (Flexible Printed Circuit Board).
  • the flexible printed circuit board may be a film such as polyethylene telephthalate (PET), polyethylene naphthalate (PEN), or polyimide (PI).
  • PET polyethylene telephthalate
  • PEN polyethylene naphthalate
  • PI polyimide
  • the measuring device is used in contact with the laryngeal muscle (including the vocal cord muscle) and the laryngeal nerve (including the recurrent laryngeal nerve) during surgery.
  • the bioelectrical signal wirelessly, it is possible to improve the risk of wire distance limitation, obstruction of the operation field of the wire, and wire break due to the limitation of the wire length between the transmitter and the receiver.
  • the receiving and display unit is known in the art If it is, it can be used.
  • FIG. 5 is a conceptual diagram of a bioelectrical signal measuring apparatus attached to an outer circumferential surface of an endotracheal tube and having a transmitter placed on a face of a patient during surgery.
  • An insulating film 20 having a wide area head and a tail portion connected to the head, and which can be attached along the length of the endotracheal tube inserted into the human body, and a head which is the opposite surface of the insulating film surface attached to the endotracheal tube Located at, the plurality of thin film electrodes 21 and the tail portion of the insulating film arranged to contact the muscle or nerve region where one portion of the endotracheal tube is located, one end is electrically connected to the thin film electrode And the other end includes a conductive wire 25 leading to the end of the tail portion.
  • the thin film electrode 21 is exposed to the outside and the conductive wire 25 is covered to extend to the conductive wire 26 extending from the insulating film, and the extended conductive wire 26 is located outside the human body.
  • the conductive wire 25 is used by insulating coating an electrical conductive tape or conductive ink.
  • the electrode for detecting the bioelectrical signal in contact with the muscle or nerve part may be a metal, alloy, or non-metallic conductor which can be inserted into the human body, and has a low electrical resistance to detect the bioelectrical signal in contact with the human muscle.
  • Conductors can be used.
  • the plurality of thin film electrodes 21 may be used by printing with conductive ink on an insulating film.
  • the conductive ink may be used as long as it has high conductivity such as conductive metal ink, conductive carbon ink or conductive polymer ink. Since the radio transmitter (not shown) is used outside the body and is not limited in size, any one known in the art may be used.
  • FIG. 6 is a cross-sectional view of a portion connecting BB ′ of FIG. 5.
  • An adhesive part 24 is positioned on a lower surface of the insulating film 20, and is positioned at the tail of the insulating film, and one end of the conductive wire 25 is electrically connected to the thin film electrode and the other end is connected to the bottom of the tail.
  • An adhesive electrical conductor tape is used, or one side of the tail is printed with conductive ink and then coated with an insulating coating.
  • the adhesive part 24 located on the lower surface of the insulating film can be used as long as it is adhesive and harmless to the human body.
  • FIG. 7 is a conceptual diagram of an endotracheal tube to which the biosignal measuring apparatus 2 of FIG. 5 is attached.
  • the measuring device is used in contact with the laryngeal muscle (including the vocal cord muscle) or laryngeal nerve (including the recurrent laryngeal nerve) during surgery.
  • a transmitter (not shown) connected to the conductive wire 26 extending from the insulating film 20 is positioned around the face of the patient and wirelessly transmits a bioelectric signal. By transmitting the bioelectrical signal wirelessly, it is possible to reduce the use distance due to the limitation of the wire length between the transmitter and the receiver, obstruct the doctor's field of vision during the operation, the risk of wire breakage.
  • a receiving and display unit for receiving a bioelectric signal transmitted wirelessly from the transmitter to the nervous system monitoring system during surgery, and, as with a wireless transmitter, any known in the art Either can be used.
  • the transmitter and the components of the nervous system monitoring system can be used repeatedly.
  • the electrical signals of the anal sphincter and the urethral sphincter can be measured.
  • the electromyography of the anal and sphincter of the anal sphincter monitors nerve damage during spinal or pelvic surgery.
  • Anal sphincter and urethral sphincter bioelectrical signal measuring device is to place the electrode in the site where the sphincter is located, the appearance can be modified to fit the structure of the anus and urethra.
  • Bio signal measuring device detection unit including a transmitter

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

Abstract

La présente invention a pour but d'installer un émetteur sans fil dans une unité émettrice d'un dispositif de mesure de signaux bioélectriques et de modifier les électrodes pour qu'elles soient fixables/retirables de manière à: empêcher que la distance utilisable du dispositif de mesure de signal bioélectrique soit restreinte par des limitations dans la longueur de fil électrique entre un émetteur et un récepteur, empêcher que le fil électrique gêne une opération en bloquant le champ de vision pendant l'opération, et réduire le danger d'un fil électrique débranché. La présente invention concerne un dispositif de mesure de signaux bioélectriques comprenant : un film isolant pouvant être fixé à la surface périphérique externe d'un biocathéter qui est inséré dans une ouverture du corps humain ; une pluralité d'électrodes à couches minces agencées pour entrer en contact avec des régions musculaires ou nerveuses au niveau desquelles une partie du biocathéter est située ; un émetteur pour transmettre sans fil un signal bioélectrique balayé par les électrodes à couches minces ; un fil conducteur connectant électriquement les électrodes à couches minces à l'émetteur ; et une batterie pour faire fonctionner l'émetteur, les électrodes, l'émetteur, le fil conducteur et la batterie étant disposés sur le film isolant. L'invention concerne également un dispositif de mesure de signaux bioélectriques composé d'une partie de tête ayant une grande superficie et une partie de queue reliée à la partie de tête, le dispositif comprenant : un film isolant pouvant être fixé le long de la longueur d'un biocathéter qui est inséré dans le corps humain ; une pluralité d'électrodes à couches minces disposées sur la partie de tête qui est la surface opposée au film isolant fixé sur le biocathéter, et agencées pour entrer en contact avec les régions musculaires ou nerveuses au niveau desquelles une partie du biocathéter est située ; et un fil isolant, ayant une extrémité connectée électriquement aux électrodes à couches minces et l'autre extrémité reliée à l'extrémité terminale de la partie de queue.
PCT/KR2014/009253 2014-10-01 2014-10-01 Dispositif de mesure de signaux bioélectriques Ceased WO2016052777A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/KR2014/009253 WO2016052777A1 (fr) 2014-10-01 2014-10-01 Dispositif de mesure de signaux bioélectriques

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Application Number Priority Date Filing Date Title
PCT/KR2014/009253 WO2016052777A1 (fr) 2014-10-01 2014-10-01 Dispositif de mesure de signaux bioélectriques

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WO2016052777A1 true WO2016052777A1 (fr) 2016-04-07

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008209219A (ja) * 2007-02-26 2008-09-11 Natl Rehabilitation Center For The Disabled フィルム電極及び該フィルム電極を用いた低侵襲センサ
KR100866545B1 (ko) * 2007-02-06 2008-11-03 연세대학교 산학협력단 비접촉 방식의 착용형 무선 생체신호 측정 시스템
JP2012130519A (ja) * 2010-12-21 2012-07-12 Nationa Hospital Organization 電極プローブ、電極プローブ導入用グリッド、および、電極プローブ製造方法
KR20140092238A (ko) * 2011-03-17 2014-07-23 브라운 유니버시티 이식가능 무선 신경 장치
KR101465355B1 (ko) * 2013-08-09 2014-12-04 서울대학교산학협력단 생체전기신호 측정장치

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100866545B1 (ko) * 2007-02-06 2008-11-03 연세대학교 산학협력단 비접촉 방식의 착용형 무선 생체신호 측정 시스템
JP2008209219A (ja) * 2007-02-26 2008-09-11 Natl Rehabilitation Center For The Disabled フィルム電極及び該フィルム電極を用いた低侵襲センサ
JP2012130519A (ja) * 2010-12-21 2012-07-12 Nationa Hospital Organization 電極プローブ、電極プローブ導入用グリッド、および、電極プローブ製造方法
KR20140092238A (ko) * 2011-03-17 2014-07-23 브라운 유니버시티 이식가능 무선 신경 장치
KR101465355B1 (ko) * 2013-08-09 2014-12-04 서울대학교산학협력단 생체전기신호 측정장치

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