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WO2025155496A1 - Confirmation de placement de tube endotrachéal et surveillance de déplacement - Google Patents

Confirmation de placement de tube endotrachéal et surveillance de déplacement

Info

Publication number
WO2025155496A1
WO2025155496A1 PCT/US2025/011370 US2025011370W WO2025155496A1 WO 2025155496 A1 WO2025155496 A1 WO 2025155496A1 US 2025011370 W US2025011370 W US 2025011370W WO 2025155496 A1 WO2025155496 A1 WO 2025155496A1
Authority
WO
WIPO (PCT)
Prior art keywords
endotracheal tube
ett
optical fiber
processor
light
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/US2025/011370
Other languages
English (en)
Inventor
Bing Yu
Tongtong LU
Joseph KERSCHNER
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.)
Medical College of Wisconsin
Marquette University
Original Assignee
Medical College of Wisconsin
Marquette University
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 Medical College of Wisconsin, Marquette University filed Critical Medical College of Wisconsin
Publication of WO2025155496A1 publication Critical patent/WO2025155496A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/306—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres
    • 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
    • A61M2205/3306—Optical measuring means
    • A61M2205/3313—Optical measuring means used specific wavelengths
    • 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
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/005—Parameter used as control input for the apparatus
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/63—Motion, e.g. physical activity

Definitions

  • An endotracheal tube is a pliable plastic duct placed into a patient’ s trachea to facilitate mechanical ventilation when a person is unable to breathe on their own. This may occur when anesthesia or substantial sedation is administered during surgery, when a patient is in the intensive care unit, or when a patient suffers from some other injury or pathologic process. Correct positioning of the ETT inside the trachea to fully ventilate the lungs is critical. Improper placement of the ETT may cause severe complications or even death, particularly in newborns and children. When an ETT is misplaced or becomes displaced, prompt intervention is required to correct the position.
  • Endotracheal tube (ETT) intubation is an important airway management procedure to enable appropriate ventilation and gas exchange in the lungs of critically ill patients or patients recovering from a major surgical intervention. Given that patients with ETT intervention are not able to breathe and ventilate on their own, ETT misplacement or intra-treatment movement is of particular' concern. The occurrence of ETT misplacement is particularly high in newborns and young children due to their shorter trachea. Currently, there is no clinical system that can be utilized to provide accurate and real-time information to care teams about the position of the ETT. [0008] Systems and methods as described herein provide an optical approach to confirm that the ETT tip is placed in an intended position and to continuously monitor the ETT tip thereafter.
  • the disclosed device includes a near-infrared (NIR) sensor that uses an optical fiber embedded in an ETT to emit NIR wavelength light, and a detector outside the body for NIR light detection.
  • NIR detector configurations are also disclosed, including a photodetector array configured for physical contact with the skin at the intended ETT tip position and a dual-camera for noncontact imaging of the NIR pattern on the skin, as well as a signal/image processor, which may for example, include a data acquisition card, a computer, and image processing algorithms.
  • a system for endotracheal tube (ETT) placement confirmation and/or displacement monitoring includes an ETT that includes an optical fiber running substantially along a length of the ETT.
  • the ETT has an insertion end and the optical fiber includes a tip proximate to the insertion end of the ETT.
  • a source of near-infrared (NIR) wavelength light is operably connected to the optical fiber.
  • a detection system is spaced apart from the ETT and the optical fiber. The detection system is configured for noninvasive detection of NIR wavelength light emitted from the optical fiber and diffused through the trachea and skin.
  • a processor is communicatively connected to the detection system and configured to receive data from the detection system. The processor is configured to determine an initial position of the tip of the optical fiber and to continuously monitor subsequent position of the tip of the optical fiber.
  • the tip of the optical fiber is inset from the insertion end of the ETT.
  • the optical fiber may be inset by 1cm from the insertion end of the ETT.
  • the tip of the optical fiber includes a 45° angle and a mirror.
  • the NIR wavelength light may be between 660nm - 2500nm, optionally the NIR wavelength light is between 780nm-850nm, optionally, the NIR wavelength light is around 810nm, the NIR wavelength light is optionally 660nm, 780nm, 800nm, 805nm, 810nm, 830nm, or 850nm.
  • the optical fiber may be inserted into a channel in the wall of the endotracheal tube.
  • the processor may be communicatively connected to the fourth and fifth photodetectors, and the processor is configured to calculate third ratio of a fourth signal from the fourth photodetector to the second signal and a fourth ratio of a fifth signal from the fifth photodetector to the second signal and to calculate a rotational displacement of the endotracheal tube from at least one of the fourth ratio and the fifth ratio.
  • the first and second ratios are further calculated from an average of the second, fourth, and fifth signals as the second signal.
  • the third and fourth ratios are further calculated from an average of the second, first, and third signals as the second signal.
  • the detection system may include an infrared light camera configured to provide infrared images to the processor and a visible light camera configured to provide visible images to the processor.
  • the processor may be configured to calculate total pixel intensities in a horizontal dimension in the infrared images against pixel position in a vertical dimension and the processor is configured to determine a rotation of the endotracheal tube from shift in the peak pixel position of the intensity profile from a reference peak pixel position.
  • the processor may be configured to calculate total pixel intensities in a vertical dimension in the infrared images against pixel position in a horizontal dimension and the processor may be configured to determine an endotracheal tube displacement from shift in the peak pixel position of the intensity profile from a reference peak pixel position.
  • the processor may be configured to fit a Gaussian distribution to the total intensity profile from which the peak position is determined.
  • the processor may be further configured to associate a visible image of the visible images to a corresponding NIR image of the infrared spectrum images collected concurrently.
  • the process or may be configured to determine an artifact patient motion between visible spectrum images.
  • the processor may be configured to calculate a corrected endotracheal tube displacement/rotation from the endotracheal tube displacement/rotation and the artifact patient motion.
  • the processor may be configured to identify a reference mark in the visible images and configured to calculate a shift in the reference mark between visible images as the artifact patient motion.
  • the processor may be configured to apply image segmentation to the visible images, and to identify corresponding feature points between visible images, and to calculate a mean disparity between the corresponding feature points between the visible images as the artifact patient motion.
  • the processor may be configured to identify a pulse artifact within a sequential series of the infrared images. Two or more additional light sources with one exemplarily between 660nm - 780nm and another exemplarily between 830nm - 950nm may be coupled to the optical fiber for use in measuring hemoglobin oxygen saturation.
  • Figure 6B represents the camera alignment with the anterior-posterior axis of the patient.
  • Figure 8 graphically depicts an example of a method of estimating ETT longitudinal displacement D x from the NIR and visible images.
  • Figure 10 presents experimental data showing the correlation between the determined peak position shift in pixel and the measured longitudinal displacement of the ETT.
  • Figure 11A depict a natural or intentionally placed visible mark for mark-based motion detection.
  • Figure 11B depicts heterogenous skin movement of the patient for subject-based motion detection.
  • the raw ETT shift 6 X must be corrected for artifacts of patient motion m x .
  • a corrected ETT shift d x is calculated according to the equation (14) below.
  • the patient motion m x must be removed from the total movement ⁇ 5 x in the image to derive actual displacement d x of the ETT.
  • the light source 36 is configured to emit an NIR wavelength between 800nm - 810nm, as well as emit red wavelength exemplarily between 650nm - 780nm and an NIR wavelength exemplarily between 830nm - 950nm. These three wavelengths are emitted sequentially.
  • the 800nm - 810nm wavelength is used for ETT detection as describe above, while the other two emitted wavelengths are used to improve pulse detection or other physiological parameters, including but not limited to blood and/or tissue oxygen saturation, and pulse oximetry (SpCh).

Landscapes

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

Abstract

Des systèmes et des procédés de confirmation de placement de tube endotrachéal (TET) et/ou de surveillance de déplacement comprennent un TET qui comprend une fibre optique s'étendant sensiblement le long d'une longueur du TET. Le TET a une extrémité d'insertion et la fibre optique comprend une pointe à proximité de l'extrémité d'insertion du TET. Une source de lumière de longueur d'onde proche infrarouge (NIR) est connectée de manière fonctionnelle à la fibre optique. Un système de détection est espacé du TET et de la fibre optique. Le système de détection est configuré pour une détection non invasive de la lumière de longueur d'onde NIR émise par la fibre optique et diffusée à travers le patient. Un processeur est connecté en communication au système de détection et configuré pour recevoir des données provenant du système de détection. Le processeur est configuré pour déterminer une position initiale de la pointe de la fibre optique et pour surveiller en continu la position ultérieure de la pointe de la fibre optique.
PCT/US2025/011370 2024-01-15 2025-01-13 Confirmation de placement de tube endotrachéal et surveillance de déplacement Pending WO2025155496A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463621058P 2024-01-15 2024-01-15
US63/621,058 2024-01-15

Publications (1)

Publication Number Publication Date
WO2025155496A1 true WO2025155496A1 (fr) 2025-07-24

Family

ID=96471892

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/011370 Pending WO2025155496A1 (fr) 2024-01-15 2025-01-13 Confirmation de placement de tube endotrachéal et surveillance de déplacement

Country Status (1)

Country Link
WO (1) WO2025155496A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080039715A1 (en) * 2004-11-04 2008-02-14 Wilson David F Three-dimensional optical guidance for catheter placement
US20110190612A1 (en) * 2010-02-02 2011-08-04 Nellcor Puritan Bennett Llc Continous Light Emission Photoacoustic Spectroscopy
US20140058253A1 (en) * 2011-04-29 2014-02-27 Board Of Regents Of The University Of Texas System Methods and Apparatus for Optoacoustic Guidance and Confirmation of Placement of Indwelling Medical Apparatus
US20200367722A1 (en) * 2013-03-15 2020-11-26 Dvl, Inc. System and device for visualization of an enclosed space
US20210007589A1 (en) * 2013-05-16 2021-01-14 Yissum Research Development Company Of The Hebrew University Of Jerusalem Ltd. Guided endotracheal intubation system
US20230419724A1 (en) * 2022-06-22 2023-12-28 Koninklijke Philips N.V. Automated camera-based non-invasive monitoring for spontaneous breathing and awakening trials in intensive care

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080039715A1 (en) * 2004-11-04 2008-02-14 Wilson David F Three-dimensional optical guidance for catheter placement
US20110190612A1 (en) * 2010-02-02 2011-08-04 Nellcor Puritan Bennett Llc Continous Light Emission Photoacoustic Spectroscopy
US20140058253A1 (en) * 2011-04-29 2014-02-27 Board Of Regents Of The University Of Texas System Methods and Apparatus for Optoacoustic Guidance and Confirmation of Placement of Indwelling Medical Apparatus
US20200367722A1 (en) * 2013-03-15 2020-11-26 Dvl, Inc. System and device for visualization of an enclosed space
US20210007589A1 (en) * 2013-05-16 2021-01-14 Yissum Research Development Company Of The Hebrew University Of Jerusalem Ltd. Guided endotracheal intubation system
US20230419724A1 (en) * 2022-06-22 2023-12-28 Koninklijke Philips N.V. Automated camera-based non-invasive monitoring for spontaneous breathing and awakening trials in intensive care

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
LU TONGTONG, KHAMPANG PAWJAI, BEYDOUN AHMED, BEREZOVSKY ANNA, ROHDE REBECCA, HONG WENZHOU, KERSCHNER JOSEPH E., YU BING: "Realtime and noninvasive assessment of endotracheal tube displacement using near-infrared and visible cameras", BIOMEDICAL OPTICS EXPRESS, OPTICAL SOCIETY OF AMERICA, UNITED STATES, vol. 15, no. 11, 1 November 2024 (2024-11-01), United States , pages 6355, XP093338822, ISSN: 2156-7085, DOI: 10.1364/BOE.531815 *

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