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WO2001091841A1 - Procede et appareil de detection de fuite par analyse, par des moyens optiques, de l'humidite du gaz de ventilation - Google Patents

Procede et appareil de detection de fuite par analyse, par des moyens optiques, de l'humidite du gaz de ventilation Download PDF

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Publication number
WO2001091841A1
WO2001091841A1 PCT/SE2001/001230 SE0101230W WO0191841A1 WO 2001091841 A1 WO2001091841 A1 WO 2001091841A1 SE 0101230 W SE0101230 W SE 0101230W WO 0191841 A1 WO0191841 A1 WO 0191841A1
Authority
WO
WIPO (PCT)
Prior art keywords
humidity
mask
sealed state
data
air
Prior art date
Application number
PCT/SE2001/001230
Other languages
English (en)
Inventor
Jan Hedner
Ludger Grote
Original Assignee
Jan Hedner
Ludger Grote
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 Jan Hedner, Ludger Grote filed Critical Jan Hedner
Priority to AU2001262867A priority Critical patent/AU2001262867A1/en
Publication of WO2001091841A1 publication Critical patent/WO2001091841A1/fr

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
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes with alarm devices
    • 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
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
    • 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
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A61M16/161—Devices to humidify the respiration air with means for measuring the humidity
    • 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
    • A61M2205/15—Detection of leaks
    • 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

Definitions

  • the present invention relates to leak detection in facial masks, in particular to the detection of leaks from nasal and facial masks used in mechanical ventilation, such as masks used in combination with or included in pressure or volume controlled ventilators, respirators or nasal CPAP (continuous positive airway pressure) systems.
  • the invention also relates to the detection of air leaking from the mouth during use of nasal masks.
  • Nasal or facial mask ventilation is widely used in the treatment of a number of conditions including obstructive sleep apnea (OSA) , central sleep apnea, various forms of nocturnal hypoventilation, diseases associated with chronic hypoventilation such as kyphoscoliosis, as a sequel of polio myelitis, pulmonary parenchymatous changes and as a general support of breathing in the intensive care unit as well as in the peri- and post operative phase.
  • OSA obstructive sleep apnea
  • central sleep apnea various forms of nocturnal hypoventilation
  • diseases associated with chronic hypoventilation such as kyphoscoliosis
  • a sequel of polio myelitis pulmonary parenchymatous changes
  • this sort of breathing support independent of type, relies for its effectiveness on an acceptably tight seal between the breathing mask and the facial surface and, in the case of a nasal mask being used, that the patient maintains a closed mouth.
  • Ventilatory systems of the kind referred to above are also frequently used by the patient at home. This means limited expert surveillance and increased vulnerability to technical failure. Systems enabling technical supervision may therefore alarm the user in time should a technical failure occur.
  • Systems enabling technical supervision may therefore alarm the user in time should a technical failure occur.
  • When used in heated spaces indoors such devices in addition, often induce dryness of the upper airway and its mucous membranes, causing patient discomfort during treatment.
  • This problem may be overcome by hu idification of the air administered to the patient via the ventilatory or CPAP system.
  • the means employed for such humidification usually rely on preheated water which is allowed to evaporate into the air stream. The need for humidification of the air stream varies depending on factors such as the humidity of the ambient air, the effectively ventilated air volume, the degree of leakage via the administration system, etc.
  • U.S. 3,580,051 discloses a method for leak testing masks by hermetically sealing a flow meter at the mouth area of the mask undergoing test and monitoring leakage due to external pressure during the mask wearer's breathing function.
  • U.S. 4,905,683 discloses a respirator mask comprising a sealing cavity defining a control chamber in a seal edge connected to a flow indicating device. A valve permitting the flow of gas from inside of the mask to the control chamber can be actuated by the wearer.
  • U.S. 5,313,937, 5,632,269, 5,803,065 (Zdrojkowski) discloses a method and apparatus for determining respiratory face mask fit which make use of the measurement of the mass of air required to compensate for a leak.
  • a leak computer such as the one disclosed in U.S.
  • 5,148,802 (Sanders et al . ) can be used in combination with a gas flow sensor.
  • a method of detecting an air leak related to a nasal or facial mask borne by a person receiving ventilatory support through the mask and being provided with breathing air of a selected humidity comprising:
  • 'air leak related to a nasal or facial mask borne by a person' is understood a leak formed between the mask and a face portion of the person wearing the mask but also a leak through the person's mouth in the case of a nasal mask being used.
  • 'monitoring the humidity' is understood the consecutive measurement, continuous or discontinuous, of the humidity prevailing inside of the mask. The measurement can be made inside of the mask but also in a portion of a tube or other conduct in communication with the mask provided that the humidity of the air in that portion is affected by the leak.
  • a tight situation that is, a situation in which there is no leak, the humidity measured in the mask during exhalation will be constant over a number of breathing cycles. The introduction of a leak will bring the humidity to a lower level. Upon tightening of the leak the humidity in the mask will rise to the original value.
  • the inspiration air provided to a patient in CPAP therapy may be humidified to a constant level.
  • level is set at from about 80 to 95 per cent relative humidity.
  • a preferred method of humidifying the inspiration air is by heated humidification (M Martins de Araujo et al . , Chest 117 (2000) 142-147).
  • a method of compensating an air leak related to a nasal or facial mask borne by a person receiving ventilatory support through the mask being provided with breathing air of a selected humidity comprising: • over several breathing cycles at the start of a period of ventilatory support, monitoring the humidity level inside of the mask or in a conduit communicating with the mask through which air exhaled by the patient passes, the mask being in a sealed state or, in case of a nasal mask, the mask being in a sealed state and the person's mouth being shut, thereby establishing a sealed state humidity level;
  • the number of breathing cycles required to establish a (baseline) sealed state humidity level is preferably from 2 to 100 cycles, most preferred from 5 to 20 cycles.
  • the period of ventilatory support may be any period useful with CPAP or other respiratory support devices.
  • an apparatus for detecting a leak related to a nasal or facial mask borne by a person receiving ventilatory support through the mask and being provided with breathing air of a selected humidity comprising a humidity sensor disposed for measurement of humidity in a flow of air exhaled by said person, humidity data storage means, humidity data comparison means and humidity data display means.
  • an apparatus for compensating a leak related to a nasal or facial mask borne by a person receiving ventilatory support through the mask and being provided with breathing air of a selected humidity comprising a humidity sensor disposed for measurement of humidity in air exhaled by said person, humidity data storage means, humidity data comparison means, means for control of one or several of inspiration airflow, inspiration air pressure, expiration air flow, expiration air pressure by data generated by said humidity data comparison means.
  • the humidity sensor is preferably an optical humidity sensor, most preferred of the kind disclosed in U.S. 5,676,154. It is advantageous to monitor and/or stabilize the temperature of the sensor to compensate for temperature changes which may affect the deposition of moisture. An electrical signal corresponding to the recorded temperature may be used to supplement the control of the ventilatory support apparatus .
  • the apparatus of the invention can be incorporated into state-of-the-art CPAP systems, for instance, the bi-level CPAP system disclosed in U.S. 5,865,173 (Froehlich) in a way such as to override the control of the blower establishing a predetermined pressurized air flow in the case of a leak.
  • the leak computer of the scheme in Fig. 2 may be substituted by microprocessor humidity data comparison means (which however should not receive an input signal from the flow transducer) the output signal of which would have to be fed to the CPAP circuitry; in addition, the pressure controller would have to be re-programmed.
  • Fig. 1 a diagram of the change of humidity in a nasal mask due to mask or mouth leakage measured by the method of the invention
  • Fig. 2 a diagram of a corresponding change of humidity due to CPAP shutdown measured by the method of the invention
  • Fig. 3 a diagram of a corresponding change of humidity during added active CPAP air stream humidification measured by the method of the invention
  • Fig. 4 a layout scheme of a CPAP system provided with a leak detection system according to the invention.
  • Figs. 1-3 illustrate different applications of an optical humidity sensor for controlling a nasal continuous positive airway pressure system. Similar or identical applications for the optical humidity sensor are applicable also to other forms of devices used to improve ventilation such as volume and pressure controlled ventilators and pure respirator systems.
  • EXAMPLE 1 Humidity sensor signal variation during experimental CPAP mask or mouth leakage.
  • a commercially available optical humidity sensor (Optovent, Bromma, Sweden) was placed in the lumen of a CPAP face mask system (ResMed. Inc., San Diego, U.S.A.) connected to a CPAP auto-titration device.
  • the humidity sensor was electrically connected to a standard optical humidity detection unit (Optovent) modified to produce an output analogue voltage of from 0 to 5V
  • the detection unit was connected to an Embla polysomnography system (Flaga, Reykjavik, Iceland) ; the output signal was analyzed by means of a Somnologica software package (Flaga, Reykjavik, Iceland) and displayed separately as well as in relation to the mask leakage signal obtained from the CPAP auto-titration system. Thereby the respiration signal was continuously monitored via the change of humidity that occurred in relation to each breath in the tightened face mask system. Graded leaks in the mask and facial system (0.1 to 1.2 liters/sec) were induced by slight dislodgment of the mask from the facial skin surface or by having the patient to slowly open the mouth in order to create variable degrees of air leak via the mouth.
  • Fig. 1 A linear relationship between the leakage in the system and the degree of reduction of the peak response of the optical humidity sensor signal was observed (Fig. 1) .
  • the dynamics of the leak signal were found to differ in speed of onset and shape of the curve in such a way that they may be systematically used in a setting such as described below to differentiate between the two different forms of leakage (mask and mouth) .
  • EXAMPLE 3 Humidity sensor signal variation during active humidification of a CPAP air stream.
  • the proportion of breaths reaching peak response was increased from 40% (room air, 20 degrees C, relative humidity 29%) to 97.5% (Fig 3) by adding active humidification by a respiratory humidifier interconnected to the CPAP tubing system (Health Care HL 100, medium heat setting, Fisher and Paykel) during constant CPAP application (6 mbar) .
  • the number of breaths reaching peak response in a lower water heating range amounted to values between these two extreme values demonstrating that there is a relationship between the degree of relative humidity of inhaled air (regulated by setting of the humidifier heating plate) and output from the optical humidity sensor when humidity is monitored in a closed mask system.
  • Example 4 Layout scheme of CPAP system provided with a leak detection system according to the invention.
  • the rough layout scheme of Fig. 4 comprises a humidity sensor disposed in the breathing air flow of the patient who is receiving breathing assistance by a CPAP or other breathing assistant device using a facial or nasal mask.
  • the sensor optically detects changes in moisture deposited on a sensor portion by an optical signal of light transmitted or reflected by said portion.
  • the light is recorded by a detector producing a corresponding analog electrical signal.
  • the electrical signal is sent to a humidity sensor signal processing unit where it is transformed to a digital signal and compared with a reference signal corresponding to the signal produced by the sensor with the in a fully sealed state.
  • An output signal of the humidity sensor processing unit is sent to a control unit controlling the CPAP-blower, ventilator, respirator or comparable breathing air flow generator.
  • the output signal sent to the breathing air flow generator will induce the generator to raise the breathing air flow but only up to a maximum preset breathing air flow pressure level.
  • the humidifier disposed in the air stream leaving the breathing air flow generator may optionally also be controlled to make it raise the humidity, in an air leakage situation, to that prevailing in the inhalation prior to the development of a leak.
  • a feedback signal from the breathing air flow generator to the control unit may be arranged so as to provide it with information to be used for humidifier control, for instance. Not at least important is the provision of an alarm which is released by the control unit in a situation with leaks of a size that cannot be easily compensated for or to alert the user or health care personnel in case of unintentional failure of the air flow or the pressure generator.

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (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)
  • Examining Or Testing Airtightness (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

L'invention concerne un procédé visant à détecter une fuite d'air se présentant sur un support de ventilation nasal ou facial, caractérisé en ce qu'on contrôle la teneur en humidité de l'air exhalé à l'intérieur d'un masque nasal ou facial en vue d'établir une teneur en humidité en l'état obturé ; on mémorise les données relatives à cette teneur en humidité en l'état obturé ; on enregistre cette teneur en humidité sur une période du support de ventilation en vue d'obtenir les données correspondantes ; on compare lesdites données d'humidité enregistrées avec les données d'humidité en l'état obturé ; et l'on détecte une fuite par observation de l'écart entre lesdites données d'humidité enregistrées par rapport aux données d'humidité en l'état obturé. L'invention concerne en outre un procédé de compensation d'une fuite d'air dans un masque, ainsi qu'un appareil pour la mise en oeuvre du procédé selon l'invention.
PCT/SE2001/001230 2000-05-31 2001-05-31 Procede et appareil de detection de fuite par analyse, par des moyens optiques, de l'humidite du gaz de ventilation WO2001091841A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001262867A AU2001262867A1 (en) 2000-05-31 2001-05-31 Method and apparatus for leak detection, by analysing humidity of ventilation gas with optical means

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE0002051-1 2000-05-31
SE0002051A SE0002051D0 (sv) 2000-05-31 2000-05-31 Läckdetektor

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006015416A1 (fr) 2004-08-10 2006-02-16 Resmed Limited Procede et appareil pour humidification de gaz respirable avec profil de livraison
WO2014052983A1 (fr) * 2012-09-28 2014-04-03 Fisher & Paykel Healthcare Limited Contrôle d'un appareil de respiration et d'humification
US9010328B2 (en) 2005-10-14 2015-04-21 Resmed Limited Flow generator message system
WO2017091665A1 (fr) * 2015-11-23 2017-06-01 Georgia Tech Research Corporation Masques faciaux de ventilation antibuée
US10279134B2 (en) 2005-03-01 2019-05-07 Resmed Limited Recognition system for an apparatus that delivers breathable gas to a patient
US10293125B2 (en) 2003-06-20 2019-05-21 Resmed Limited Flow generator with patient reminder
CN111184932A (zh) * 2019-12-02 2020-05-22 湖南明康中锦医疗科技发展有限公司 呼吸支持设备漏气量检测方法及呼吸支持设备
US20210255055A1 (en) * 2020-02-14 2021-08-19 Loewenstein Medical Technology S.A. Monitoring system for detecting leakages during ventilation, and method
AU2020267173B2 (en) * 2009-12-01 2022-10-06 Fisher & Paykel Healthcare Limited Breathing assistance apparatus

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4765325A (en) * 1986-12-12 1988-08-23 Crutchfield Clifton D Method and apparatus for determining respirator face mask fit
EP0536978A1 (fr) * 1991-10-08 1993-04-14 FISHER & PAYKEL LIMITED Capteur d'humidité
EP0722747A2 (fr) * 1994-12-15 1996-07-24 Devilbiss Health Care, Inc. Appareil pour la ventilation spontanée en pression positive continue (VSPPC)
JPH08308931A (ja) * 1995-05-19 1996-11-26 Shigeo Sato 気体加湿器
US5661231A (en) * 1995-05-12 1997-08-26 Instrumentarium Oy Arrangement for leak testing place in connection with a ventilator
WO1998012965A1 (fr) * 1996-09-23 1998-04-02 Resmed Limited Ventilation assistee conçue pour repondre aux besoins respiratoires du patient

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4765325A (en) * 1986-12-12 1988-08-23 Crutchfield Clifton D Method and apparatus for determining respirator face mask fit
EP0536978A1 (fr) * 1991-10-08 1993-04-14 FISHER & PAYKEL LIMITED Capteur d'humidité
EP0722747A2 (fr) * 1994-12-15 1996-07-24 Devilbiss Health Care, Inc. Appareil pour la ventilation spontanée en pression positive continue (VSPPC)
US5661231A (en) * 1995-05-12 1997-08-26 Instrumentarium Oy Arrangement for leak testing place in connection with a ventilator
JPH08308931A (ja) * 1995-05-19 1996-11-26 Shigeo Sato 気体加湿器
WO1998012965A1 (fr) * 1996-09-23 1998-04-02 Resmed Limited Ventilation assistee conçue pour repondre aux besoins respiratoires du patient

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PATENT ABSTRACTS OF JAPAN *

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10293125B2 (en) 2003-06-20 2019-05-21 Resmed Limited Flow generator with patient reminder
US10220178B2 (en) 2004-08-10 2019-03-05 Resmed Limited Method and apparatus for humidification of breathable gas with profiled delivery
US11318273B2 (en) 2004-08-10 2022-05-03 ResMed Pty Ltd Method and apparatus for humidification of breathable gas with profiled delivery
WO2006015416A1 (fr) 2004-08-10 2006-02-16 Resmed Limited Procede et appareil pour humidification de gaz respirable avec profil de livraison
EP1804876A4 (fr) * 2004-08-10 2017-06-14 ResMed Limited Procede et appareil pour humidification de gaz respirable avec profil de livraison
US11077282B2 (en) 2004-08-10 2021-08-03 ResMed Pty Ltd Method and apparatus for humidification of breathable gas with profiled delivery
US10279134B2 (en) 2005-03-01 2019-05-07 Resmed Limited Recognition system for an apparatus that delivers breathable gas to a patient
US10076617B2 (en) 2005-10-14 2018-09-18 Resmed Limited Flow generator message system
US9010328B2 (en) 2005-10-14 2015-04-21 Resmed Limited Flow generator message system
US12329905B2 (en) 2005-10-14 2025-06-17 ResMed Pty Ltd Flow generator message system
US11033699B2 (en) 2005-10-14 2021-06-15 ResMed Pty Ltd Flow generator message system
AU2020267173B2 (en) * 2009-12-01 2022-10-06 Fisher & Paykel Healthcare Limited Breathing assistance apparatus
US12220529B2 (en) 2009-12-01 2025-02-11 Fisher & Paykel Healthcare Limited Breathing assistance apparatus
US10441740B2 (en) 2012-09-28 2019-10-15 Fisher & Paykel Healthcare Limited Humidification breathing apparatus control
AU2020202230B2 (en) * 2012-09-28 2021-09-09 Fisher & Paykel Healthcare Limited Humidification breathing apparatus control
AU2013323113B2 (en) * 2012-09-28 2018-05-17 Fisher & Paykel Healthcare Limited Humidification breathing apparatus control
AU2021282450B2 (en) * 2012-09-28 2023-10-19 Fisher & Paykel Healthcare Limited Humidification breathing apparatus control
WO2014052983A1 (fr) * 2012-09-28 2014-04-03 Fisher & Paykel Healthcare Limited Contrôle d'un appareil de respiration et d'humification
WO2017091665A1 (fr) * 2015-11-23 2017-06-01 Georgia Tech Research Corporation Masques faciaux de ventilation antibuée
CN111184932A (zh) * 2019-12-02 2020-05-22 湖南明康中锦医疗科技发展有限公司 呼吸支持设备漏气量检测方法及呼吸支持设备
US20210255055A1 (en) * 2020-02-14 2021-08-19 Loewenstein Medical Technology S.A. Monitoring system for detecting leakages during ventilation, and method
US11921011B2 (en) * 2020-02-14 2024-03-05 Loewenstein Medical Technology S.A. Monitoring system for detecting leakages during ventilation, and method

Also Published As

Publication number Publication date
SE0002051D0 (sv) 2000-05-31
AU2001262867A1 (en) 2001-12-11

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