WO2011068741A1 - Détection de l'emplacement d'un tube endotrachéal - Google Patents

Détection de l'emplacement d'un tube endotrachéal Download PDF

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Publication number
WO2011068741A1
WO2011068741A1 PCT/US2010/058144 US2010058144W WO2011068741A1 WO 2011068741 A1 WO2011068741 A1 WO 2011068741A1 US 2010058144 W US2010058144 W US 2010058144W WO 2011068741 A1 WO2011068741 A1 WO 2011068741A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
proximal
sensor assembly
endotracheal tube
distal
Prior art date
Application number
PCT/US2010/058144
Other languages
English (en)
Inventor
Shlomo Besharim
Original Assignee
Mor Research Applications Ltd.
Klein, David
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 Mor Research Applications Ltd., Klein, David filed Critical Mor Research Applications Ltd.
Publication of WO2011068741A1 publication Critical patent/WO2011068741A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0411—Special features for tracheal tubes not otherwise provided for with means for differentiating between oesophageal and tracheal intubation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards

Definitions

  • the present invention relates to apparatus and methods for sensing endotracheal tube location.
  • an endotracheal tube is inserted into the patient' s mouth and then into the trachea, so that the distal end of the tube is placed just above the carina (the central ridge formed by the bifurcation of the trachea into the left and right bronchus).
  • the proximal end of the breathing tube is usually connected to an airway tube that leads to a controllable gas supply delivery system (ventilator).
  • the endotracheal tube may alternatively be introduced through the nostrils, or in rare acute emergency situations, directly into the trachea via tracheostomy or tracheotomy.
  • Endotracheal intubation may be complicated by inadvertent insertion of the endotracheal tube into the esophagus, or past the carina into one of the right primary bronchus or the left primary bronchus. Also, post placement movement of the distal endotracheal tube tip past either the carina or above the vocal cords due to patient or ventilator tube movement, or mucus blockage of the endotracheal tube lumen can occur over time. In such cases, the patient is ineffectively ventilated, which may result in severe medical complications.
  • location of the endotracheal tube may be determined by different methods, including stethoscopic evaluation of the airway, breath, and epigastric sounds, chest x-rays, ultrasonic techniques, optical techniques, and many others.
  • the present invention seeks to provide novel apparatus and methods for sensing endotracheal tube location, as is described more in detail further below.
  • apparatus including a proximal sensor assembly and a distal sensor assembly disposed on an endotracheal tube at a distance from one another, wherein each sensor assembly includes one or more sensors that output a signal that is a function of a distance from the sensor to the nearest surrounding object such that the signal of the sensor differs detectably depending whether the sensor is located in an oral cavity, trachea, left or right bronchus of a subject.
  • a processor is provided that compares and processes data from the proximal and distal sensor assemblies for recording or displaying on a display.
  • the proximal sensor assembly and/or the distal sensor assembly includes one or more capacitance proximity sensors.
  • proximal and distal sensor assemblies are disposed on either side of a fixation element (e.g., an inflatable balloon) mounted on the endotracheal tube.
  • a fixation element e.g., an inflatable balloon mounted on the endotracheal tube.
  • a method for sensing location of an endotracheal tube including providing a proximal sensor assembly and a distal sensor assembly disposed on an endotracheal tube at a distance from one another, wherein each sensor assembly includes one or more sensors that output a signal that is a function of a distance from the sensor to the nearest surrounding object such that the signal of the sensor differs detectably depending whether the sensor is located in an oral cavity, trachea, left or right bronchus of a subject, and processing and comparing the signals of the proximal and distal sensor assemblies to determine whether the sensor is located in an oral cavity, trachea, left or right bronchus of a subject.
  • Fig. 1 is a simplified pictorial illustration of apparatus for sensing endotracheal tube location, constructed and operative in accordance with a non-limiting embodiment of the present invention
  • Fig. 2 is a simplified enlarged illustration of a capacitance sensor used in the apparatus of Fig. 1 ;
  • Fig. 3 is a simplified pictorial illustration of the apparatus of Fig. 1 , inserted in the oral cavity of a patient with a proximal sensor in the oral cavity and a distal sensor in the trachea;
  • Fig. 4 is a simplified pictorial illustration of the apparatus fully inserted in the trachea of a patient with both the proximal and distal sensors in the trachea
  • Fig. 5 is a simplified pictorial illustration of the apparatus incorrectly inserted in the trachea of a patient with the proximal sensor in the trachea and the distal sensor in the right bronchus;
  • Figs. 6A-6D are simplified illustrations of another version of apparatus for sensing location of the endotracheal tube, constructed and operative in accordance with a non- limiting embodiment of the present invention.
  • FIG. 1 illustrates apparatus 10 for sensing location of an endotracheal tube 12, constructed and operative in accordance with a non- limiting embodiment of the present invention.
  • An endotracheal tube 12 includes a proximal sensor assembly 14 and a distal sensor assembly 16.
  • Each sensor assembly includes one or more sensors that output a signal that is a function of a distance from the sensor to the nearest surrounding object.
  • the signal of the sensor is a function of the distance from the sensor to the lumen wall, that is, the inner wall of the oral cavity, trachea or bronchus, for example.
  • the oral cavity is larger in cross-sectional area than the trachea, and the trachea is larger in cross- sectional area than the bronchus. If the cross-sectional area of the trachea is considered a reference baseline of 100%, than the right bronchus is 60% and the left bronchus is 40%.
  • the signal from the sensor will differ detectably depending whether the sensor is located in the oral cavity, trachea, left or right bronchus; it will also be different if accidentally placed in the esophagus.
  • each sensor assembly includes one or more capacitance proximity sensors 18.
  • Another suitable sensor would be an infrared or optical proximity sensor.
  • Another example of a volumetric sensor is a set of impedance sense electrodes located along a single impedance lead or on a plurality of impedance leads, wherein volume determining circuitry is coupled to the impedance sensor electrodes and detects impedance between selected electrode pairs, wherein the measured impedance changes with the volume surrounding the electrode pairs.
  • proximal sensor assembly 14 and distal sensor assembly 16 are disposed on either side of a fixation element 28, such as a fixation balloon, which may be inflated by an inflation controller 30.
  • FIG. 3 illustrate the principles of operation of apparatus 10.
  • apparatus 10 is inserted in the oral cavity 32 of a patient.
  • Proximal sensor 14 is in the oral cavity 32 and distal sensor 16 is in the trachea 34.
  • Processor 24 would interpret and understand (e.g., based upon data stored in memory) that the larger volume surrounding proximal sensor assembly 14 as opposed to the distal sensor assembly 16 means proximal sensor 14 is in the oral cavity 32 and distal sensor 16 is in the trachea 34.
  • apparatus 10 is fully and correctly inserted in the trachea 34, and both the proximal and distal sensors 14 and 16 are in the trachea 34.
  • the processor 24 would compare and process the information from proximal and distal sensors 14 and 16 and this position would be shown on display 26.
  • apparatus 10 is incorrectly inserted in the trachea 34, wherein the proximal sensor 14 is in the trachea 34 but the distal sensor 16 is in the right bronchus 38.
  • the processor 24 would process the information from proximal and distal sensors 14 and 16 and this incorrect position would be shown on display 26 to alert the user that the position is incorrect.
  • the distal sensor 16 were in the left bronchus 36 or the esophagus (not shown).
  • Apparatus 10 continuously measures the position of endotracheal tube 12 throughout the medical procedure (e.g., surgery, inhalation, etc.). This is a significant advantage over prior art devices, because any movement of the patient or the endotracheal tube (such as by movement of the medical personnel) can change the position of the endotracheal tube, and in the event of such movement apparatus 10 will signal the medical personnel in order to take proper corrective action.
  • FIGs. 6A-6D illustrates another version of apparatus for sensing location of the endotracheal tube, constructed and operative in accordance with a non-limiting embodiment of the present invention.
  • An endotracheal tube 42 includes a proximal capacitance proximity sensor 44 and a distal capacitance proximity sensor 46.
  • the sensors may be constructed as conductive rings (metal or conductive elastomer).
  • a bioelectrode 48 is also provided in contact with tissue. Bioelectrode 48 can be separate from endotracheal tube 42 (the embodiment of Fig. 6A) or can be mounted on a portion of endotracheal tube 42 (the embodiment of Fig. 6B).
  • the sensors 44 and 46 and the bioelectrode 48 are connected to processor 24 (e.g., an AD 7150 microprocessor) by leads 51-53 respectively (as shown in Figs. 6C-6D).
  • capacitance measurements to assess distance may be performed between the two sensors 44 and 46. This measurement provides a distance between the two sensors and the trachea. In another option, capacitance measurements may be performed between the body tissue or the trachea and the two sensors as two separate capacitances.
  • the processor 24 calculates the differential capacitance between the sensors 44 and 46 and the tissue; the differential measurement is an output that is proportional to the difference between the capacitances. In this option, if the distal sensor 46 is in the left or right primary bronchus then the capacitances will be different and an alarm will be generated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Endoscopes (AREA)

Abstract

La présente invention a pour objet un appareil comprenant un ensemble de capteurs proximal (14) et un ensemble de capteurs distal (16) disposés sur un tube endotrachéal (12) à distance l'un de l'autre, chaque ensemble de capteurs (14, 16) comprenant un ou plusieurs capteurs qui produisent en sortie un signal qui est une fonction d'une distance du capteur à l'objet le plus proche de telle sorte que le signal du capteur diffère de manière détectable selon que le capteur est situé dans une cavité orale, la trachée, la bronche gauche ou droite d'un sujet.
PCT/US2010/058144 2009-12-02 2010-11-29 Détection de l'emplacement d'un tube endotrachéal WO2011068741A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26576909P 2009-12-02 2009-12-02
US61/265,769 2009-12-02

Publications (1)

Publication Number Publication Date
WO2011068741A1 true WO2011068741A1 (fr) 2011-06-09

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Family Applications (1)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102755686A (zh) * 2012-08-09 2012-10-31 台州瀚创医疗器械科技有限公司 S形可视硬质插管芯
WO2013001531A3 (fr) * 2011-06-28 2013-04-11 Breslauer Ltd. Ensemble de masque laryngé amélioré
EP3000497A3 (fr) * 2014-09-29 2016-07-06 Becton Dickinson and Company Détection d'insertion d'une canule
US20210121651A1 (en) * 2019-10-23 2021-04-29 Endolynx, Inc. Methods and devices for determining a position of an endotracheal tube

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4967759A (en) * 1988-06-29 1990-11-06 Teves Leonides Y Cardiac monitor with endotracheal sensor
WO2006116597A2 (fr) * 2005-04-26 2006-11-02 Acclarent, Inc. Procedes et dispositifs permettant de realiser des operations a l'interieur de l'oreille, du nez, de la gorge et des sinus paranasaux
WO2008113008A2 (fr) * 2007-03-14 2008-09-18 Waitzman Kathryn A Mckenzie Procédés et systèmes pour localiser un tube d'alimentation à l'intérieur d'un patient

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4967759A (en) * 1988-06-29 1990-11-06 Teves Leonides Y Cardiac monitor with endotracheal sensor
WO2006116597A2 (fr) * 2005-04-26 2006-11-02 Acclarent, Inc. Procedes et dispositifs permettant de realiser des operations a l'interieur de l'oreille, du nez, de la gorge et des sinus paranasaux
WO2008113008A2 (fr) * 2007-03-14 2008-09-18 Waitzman Kathryn A Mckenzie Procédés et systèmes pour localiser un tube d'alimentation à l'intérieur d'un patient

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
WEIJIANG PAN ET AL: "A new magnetic device for the identification of endotracheal tube position", PROCEEDINGS OF THE 23RD. ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY. 2001 CONFERENCE PROCEEDINGS. (EMBS). INSTANBUL, TURKEY, OCT. 25 - 28, 2001; [ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN, vol. 4, 25 October 2001 (2001-10-25), pages 3273 - 3276, XP010593801, ISBN: 978-0-7803-7211-5 *

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013001531A3 (fr) * 2011-06-28 2013-04-11 Breslauer Ltd. Ensemble de masque laryngé amélioré
CN102755686A (zh) * 2012-08-09 2012-10-31 台州瀚创医疗器械科技有限公司 S形可视硬质插管芯
EP3000497A3 (fr) * 2014-09-29 2016-07-06 Becton Dickinson and Company Détection d'insertion d'une canule
US9872633B2 (en) 2014-09-29 2018-01-23 Becton, Dickinson And Company Cannula insertion detection
EP3628346A1 (fr) * 2014-09-29 2020-04-01 Becton, Dickinson and Company Détection d'insertion d'une canule
EP3662944A1 (fr) * 2014-09-29 2020-06-10 Becton, Dickinson and Company Détection d'insertion d'une canule
US11490831B2 (en) 2014-09-29 2022-11-08 Becton, Dickinson And Company Cannula insertion detection
US11890088B2 (en) 2014-09-29 2024-02-06 Becton, Dickinson And Company Cannula insertion detection
US20210121651A1 (en) * 2019-10-23 2021-04-29 Endolynx, Inc. Methods and devices for determining a position of an endotracheal tube
US11986593B2 (en) 2019-10-23 2024-05-21 Endolynx, Inc. Methods and devices for determining a position of an endotracheal tube

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