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WO2025088384A1 - Système de détection rapide pour intubation trachéale et oesophagienne - Google Patents

Système de détection rapide pour intubation trachéale et oesophagienne Download PDF

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Publication number
WO2025088384A1
WO2025088384A1 PCT/IB2024/050518 IB2024050518W WO2025088384A1 WO 2025088384 A1 WO2025088384 A1 WO 2025088384A1 IB 2024050518 W IB2024050518 W IB 2024050518W WO 2025088384 A1 WO2025088384 A1 WO 2025088384A1
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Prior art keywords
intubation
endotracheal tube
pressure
ett
tracheal
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PCT/IB2024/050518
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English (en)
Inventor
Wijeratne Mudiyanselage Don Suranga Pradeep Kumaru WIJERATNE
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Classifications

    • 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. ventilators; 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
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission

Definitions

  • the present disclosure relates generally to systems and methods to intubate a patient, and more particularly to systems and methods to recognize and rapidly act in case of oesophageal intubation.
  • A61 M 16/00 Devicesfor influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes (stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61 H 31/00) [2006.01],
  • the present disclosure relates to medical apparatus used in the field of anesthesiology and to methods to ensure mistake-free tracheal intubation. It is common practice to use an Endotracheal Tube (ETT) to give mechanical breathing I artificial ventilation during general anesthesia.
  • ETT comprises a rigid air conduit constructed of medical grade plastics that is to be placed in the patient's trachea.
  • the distal end of the ETT used in general applications has a side hole thatenables the air flow in case of an obstruction in the main passage.
  • the proximal end of the ETT has a standard fitting that allows the connection to an external source of pressurized gas such as oxygen, air and anesthetic gases by the breathing system.
  • the ETT could be correctly placed in the trachea under direct visualization using a laryngoscope.
  • the popularly used conventional laryngoscope is considered as the most successful durable instrument in the history of anesthesia.
  • US patents US5095888A & US5498231A are two such examples.
  • the esophagus is a muscular tube whose size ranges from 18 to 26 cm in length and it serves as a passageway for food and liquids to travel from the mouth to the stomach. It is usually an airless, self-collapsing tube that resembles an organ that naturally collapses when at rest.
  • the trachea also known as windpipe, is a hollow conduit which permits inhaled and exhaled air to pass from upper airway to both bronchi.
  • the trachea is in the upper anterior part of the chest and oesophagus lies behind it.
  • the trachea shown in Fig.3 consists of a series of C-shaped cartilage rings (209), numbering between 16 &22.
  • the cavity (208) of the trachea will maintain its hollow shape even after the patient is subjected to general anesthesia.
  • esophagus(201 ) collapses (202)when the patient is in the supine position under general anesthesia as shown in Fig. 3.
  • Fig. 2 shows the open vocal cord condition as opposed to its closed condition. Under general anesthesia, muscular paralysis takes place. Hence the vocal cords are subjected to paralysis and remain open position.
  • the lungs are at their functional residual capacity (FRC) and the patient is unable to breathe due to muscle paralysis.
  • FRC functional residual capacity
  • the environment and lung alveoli will continue to retain the same air column with no air flow.
  • the air contained in the lung (alveoli) isconnected withthe atmospheric pressure via the trachea. So internal pressure of the trachea is equal to the atmospheric pressure.
  • the patient has to be externally supplied with Oxygen, air and other gasses during general anesthesia, to provide ventilation and to maintain anesthesia. This is achieved by performing mechanical ventilation via the Endotracheal Tube (ETT)placed in the trachea.
  • ETT Endotracheal Tube
  • the insertion of the ETT is a skilled procedure performed by an experienced clinician such as anesthetist.
  • the major challenge is to ensure that the ETT is placed in the trachea and not in the esophagus.
  • the placement of an ETT in the esophagus which is termed as oesophageal intubation, can be catastrophic within minutes. It is important to detect esophageal intubation at the earliest possible instance as any delay can lead to a life-threatening clinical condition including death.
  • any technique for the rapid detection of incorrect intubation namely oesophageal intubation
  • the present inventive technique disclosed will help to alleviate this situation by identifying oesophageal intubation in a very short time span.
  • Intubation process requires the insertion of an artificial airway such as ETT to the trachea using laryngoscopy.
  • Orotracheal tube is more common than the nasotracheal tube.
  • the ability to see the tube passing between the vocal cords and anterior to the arytenoids should be assessed before withdrawing the laryngoscope blade.
  • capnography is considered as the gold standard technique to differentiate tracheal intubation from oesophageal intubation.
  • Capnography is the monitoring of the concentration or partial pressure of carbon dioxide (CO 2 ) in the exhaled air. Its main development has been as a monitoring tool for use during anesthesia and intensive care. The observed values are presented as a graph of carbon dioxide (CO 2 ) plotted against time.
  • the Chinese patent CN212187391 II discloses a pressure monitorable endotracheal tube ETT comprising an air pressure sensor and a pilot indicator. It uses a tracheal catheter to obtain the pressure.
  • CN216824408U also discloses a tracheal catheter capable of quickly judging the position of the ETT using the colour change of a carbon dioxide test paper placed at the inner wall of the transparent annular joint.
  • US8998798B2 utilizes a multi-lumen tube with an integral visualization apparatus, such as a camera. It is an extended visualization device.
  • a differential ultra-sensitive pressure transducer determines and monitors the pressure differentials between the breathing track and the ambient. It does not indicate the pressure in the esophagus.
  • An End-tidal carbon dioxide guide intubation tube capable of monitoring carbon dioxide content is disclosed in CN215135323U. It measures the flow of carbon dioxide from the lungs and has visual tools to help make sure the tube is in the right place.
  • the airflow is monitored using a microphone airflow sensor.
  • the sensor is activated by pressing the abdominal area of the patient.
  • the preferred embodiment of the device disclosed here is based on a conventional Endotracheal Tube (ETT) (102) of prior art and consists of a flexible tube extending from the distal end (100) to the connector at the proximal end (114) as shown in Fig 4. It is used to assist the breathing process during a surgery or to support breathing in case of a lung malfunction, chest trauma orairway obstruction.
  • the cuff (101) disposed at the distal end (100) is inflated using the pilot balloon (103) disposed close to the proximal end (114) of the ETT. Once inflated, the cuff provides a seal within the airway preventing the passage of air around the ETT (102)and prevents mouth secretions entering the lung.
  • the standard 15mm connector (104) at the proximal end (114) is the same used in the prior art applications.
  • the present device is plugged into this standard 15mm connector (104) via the female adapter (105) which carries a non-elastic minimal flexible tube (106).
  • the minimal flexible tube (106) carrying the vital signals is connected to the ultra-sensitive pressure transducer (108) of monitoring device of this disclosure via the connector (107).
  • Signal from the Bluetooth and the Wi-Fi module (111 ) can be received by any Android and Apple device installed with the custom designed App.
  • the ultra-sensitive pressure transducer (108) is used to convert mechanical pressure in the air column to a signal in the form of an electrical signal.
  • the motherboard (112) receiving the signal identifies and amplifies it. It produces a corresponding waveform, which can be transmitted via the connected Bluetooth and Wi-Fi modules (111 ).
  • Android and Apple devices can receive this transmitted data and produce a graph according the pressure change while advancing the ETT.
  • the HX-710B pressure sensor and transducer is a unit that can sense pressure and convert mechanical stress to an electrical signal.
  • the motherboard (112) is an chicken mega board.
  • the Bluetooth Module HS-06 is a Bluetooth 2.0 protocol-based device enabling short-range wireless data communication between microcontrollers or systems and the Wi-Fi module is a ESP-8266 Wi-Fi Module which is a versatile short-range wireless data communication solution, enabling high-speed connectivity between microcontrollers or systems operating at a 2.4 GHz frequency.
  • the signal from the Bluetooth module can be received by Android tablet, phone, or any Bluetooth device and anyWi-Fidevice can accessWi-Fi data in a remote manner.
  • the non-elastic minimal flexible tube (106) of the present device is fitted to the conventional ETT (102) using standard 15mm connector (104) and the female adapter (105).
  • the Bluetooth And Wi-Fi module (111 ) should be kept in the active mode.
  • the patient undergoing general anesthesia is now laid down on the theater table in the supine posture.
  • the recommended dose of anesthetics is now administered.
  • the Anesthetist now inserts the ETT (102) in to the patient through the open vocal cord (205).
  • the ETT (102) gradually passes in and should get landed in the trachea (200) and not the oesophagus (201).
  • ETT should be placed correctly in trachea (204). Incorrectly placed ETT is (203) leads to complications.
  • New device has a female adapter to connect to proximal end of the ETT. So, it will seal the air column in the ETT.
  • This adapter, together with the associated system should be connected to ETT before intubation.
  • Trachea is an open cartilaginous stiff structure whereas the esophagus is muscular in composition.
  • the cavity of trachea remains open due to the C-shaped rings (209) which are stiff in structure.
  • the cavity in trachea is ready to accept the ETT without any resistance. Once the ETT goes into the trachea, the pressure inside the ETT equalizes with that in the ambient as excess air in the system will escape through the gap surrounding the ETT.
  • the esophagus is in a collapsed state when the patient is under anesthesia.
  • the ETT has to be pushed into the collapsed esophagus by the anesthetist administering the system. This situation is illustrated stepwise in the figures 5-8. This can be explained as follows.
  • Fig. 5 illustrates the position A of the ETT when it is about to touch the esophagus.
  • Fig. 6 shows the ETT at position B, when the ETT almost touches the esophagus.
  • the distal end (100) of the ETT traps a small amount of air from the air present in the free space around it.
  • This small pocket of air (211 ) is connected to the air column inside the ETT.
  • the pushing action causes a slight fluctuation in the pressure in the air column. This does not happen when the ETT is in the trachea and can be termed as tissue resistance. This distinction is used to detect oesophagus intubation in the present disclosure.
  • the points A and B shown in the pressure graph refer to the positions A & B in Fig. 5 and Fig. 6 respectively.
  • This position C is illustrated in Fig. 7 and the corresponding pressure in the pocket of air (212) is shown at C in Fig. 9.
  • the pressure in the small pocket of air (213) will increase further (point D in the graph).
  • the pressure signal returns to the base value (point E in the graph). It is clear that there is no pressure peak in the case of trachea (Fig.10) compared to oesophagus intubation (Fig. 9).
  • Fig. 9 & Fig. 10 show the pressure signal produced via the custom designed App for Android and Apple device, when the ETT is inserted into the esophagus and trachea respectively.
  • the maximum pressure obtained in oesophageal intubation is 3.0-5.0 cmH20 and the maximum pressure obtained in tracheal intubation is 0.1 -1.0 cmH20.
  • the device in the present disclosure is to recognise the point of entry of the ETT into the oesophagus.
  • the time delay between the point of entry and the indication by the device is less than 1 second.
  • the sudden increase in pressure is set to activate a visible and an audible signal.
  • Fig. 1 (a) shows the case when the ETT is in the esophagus. This situation can lead to life-threatening complications in the patient and has to be avoided.
  • Fig. 2 is the entry point of the ETT.
  • the ETT has to pass through the opening of the vocal cord.
  • Fig. 3 shows a detailed view of the trachea anterior and the esophagus posterior in the collapsed status.
  • Fig. 4 is a skeletal representation of the system in disclosure attached to the proximal end of the ETT.
  • Fig. 5 - Fig. 8 show the critical positions of the distal end of the ETT required to understand the principle of the inventive method.
  • Fig. 5 shows the position A of the ETT when it is close to the collapsed esophagus. There is no effect on the air column at this point. The pressure is at the base value.
  • Fig. 6 shows the position B of the ETT when the distal end (tip) touched the collapsed oesophagus. The pressure in the air pocket trapped at the tip will start to increase.
  • Fig. 7 shows the position C of the ETT when the distal end (tip) after it enters the collapsed esophagus. The pressure in the air pocket will remain elevated beyond this point.
  • Fig. 8 shows the position D of the ETT when the distal end (tip) is inside the collapsed esophagus. The pressure in the air pocket will remain elevated.
  • Fig. 9 is the graph of pressure inside the ETT as sensed by the Ultra-sensitive pressure sensor when the ETT goes through oesophageal intubation, is shown in the android and apple devices with specially designed App.
  • Fig. 10 is the graph of pressure inside the ETT as sensed by the Ultra-sensitive pressure sensor when the ETT goes through tracheal intubation, is shown in the android and apple devices with specially designed App.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente divulgation concerne des systèmes et des procédés qui font appel à un module d'indication de pression ultra-sensible qui répond rapidement à tout changement de la colonne d'air à l'intérieur d'un tube endotrachéal. Le système comprend un tube endotrachéal classique dont la colonne d'air est scellée à l'aide d'un tube souple conjointement avec le transducteur de pression ultrasensible couplé à un système de génération de signal. La pression est représentée graphiquement, et le système active une unité d'alarme en cas d'accumulation de pression excessive.
PCT/IB2024/050518 2023-10-23 2024-01-19 Système de détection rapide pour intubation trachéale et oesophagienne Pending WO2025088384A1 (fr)

Applications Claiming Priority (2)

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LKLK/P/1/22891 2023-10-23
LK2289123 2023-10-23

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5095888A (en) 1990-07-09 1992-03-17 Circon Corporation Intubating stylet for a laryngoscope
US5498231A (en) 1994-03-07 1996-03-12 Franicevic; Klaus Intubating laryngoscope
US20110245704A1 (en) * 2008-12-11 2011-10-06 Koen Monsieurs Methods and systems for analysing resuscitation
US8998798B2 (en) 2010-12-29 2015-04-07 Covidien Lp Multi-lumen tracheal tube with visualization device
US9259542B2 (en) 2005-11-22 2016-02-16 General Electric Company Respiratory monitoring with differential pressure transducer
CN212187391U (zh) 2019-09-29 2020-12-22 无锡圣诺亚科技有限公司 一种可监测压力的气管导管
CN213491303U (zh) 2020-08-19 2021-06-22 何义周 一种带气流感应检测的中继气管插管
CN215135323U (zh) 2021-06-15 2021-12-14 上海交通大学医学院附属第九人民医院 一种可监测二氧化碳含量的呼气末二氧化碳引导插管
CN216824408U (zh) 2021-10-19 2022-06-28 西安医学院第一附属医院 一种可快速判断位置的气管导管

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5095888A (en) 1990-07-09 1992-03-17 Circon Corporation Intubating stylet for a laryngoscope
US5498231A (en) 1994-03-07 1996-03-12 Franicevic; Klaus Intubating laryngoscope
US9259542B2 (en) 2005-11-22 2016-02-16 General Electric Company Respiratory monitoring with differential pressure transducer
US20110245704A1 (en) * 2008-12-11 2011-10-06 Koen Monsieurs Methods and systems for analysing resuscitation
US8998798B2 (en) 2010-12-29 2015-04-07 Covidien Lp Multi-lumen tracheal tube with visualization device
CN212187391U (zh) 2019-09-29 2020-12-22 无锡圣诺亚科技有限公司 一种可监测压力的气管导管
CN213491303U (zh) 2020-08-19 2021-06-22 何义周 一种带气流感应检测的中继气管插管
CN215135323U (zh) 2021-06-15 2021-12-14 上海交通大学医学院附属第九人民医院 一种可监测二氧化碳含量的呼气末二氧化碳引导插管
CN216824408U (zh) 2021-10-19 2022-06-28 西安医学院第一附属医院 一种可快速判断位置的气管导管

Non-Patent Citations (10)

* Cited by examiner, † Cited by third party
Title
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JABER ET AL., CRITCARE MED, 2006, pages 34
JABER S ET AL.: "An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center stu", INTENSIVE CARE MEDICINE, vol. 36, 2010, pages 248 - 255, XP037136372, DOI: 10.1007/s00134-009-1717-8
JABER SAMRAOUI JLEFRANT JY: "Clinical practice and risk factors for immediate complications of endotracheal intubation in intensive care unit: A prospective multiple-center study", CRITICAL CARE MEDICINE, vol. 34, 2006, pages 2355 - 2361
KALMAR ALAIN F ET AL: "Automatic detection of oesophageal intubation based on ventilation pressure waveforms shows high sensitivity and specificity in patients with pulmonary disease", RESUSCITATION, ELSEVIER, IE, vol. 105, 19 May 2016 (2016-05-19), pages 36 - 40, XP029651177, ISSN: 0300-9572, DOI: 10.1016/J.RESUSCITATION.2016.05.010 *
MORT TC: "Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts", ANESTHESIA & ANALGESIA, vol. 99, 2004, pages 607 - 613
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SCHWARTZ DEMATTHAY MACOHEN NH: "Death and other complications of emergency airway management in critically ill patients: a prospective investigation of 297 tracheal intubations", ANAESTHESIOLOGY, vol. 82, 1995, pages 367 - 376
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