WO2008143506A1 - Dispositif de test et d'étalonnage - Google Patents

Dispositif de test et d'étalonnage Download PDF

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Publication number
WO2008143506A1
WO2008143506A1 PCT/NL2008/050298 NL2008050298W WO2008143506A1 WO 2008143506 A1 WO2008143506 A1 WO 2008143506A1 NL 2008050298 W NL2008050298 W NL 2008050298W WO 2008143506 A1 WO2008143506 A1 WO 2008143506A1
Authority
WO
WIPO (PCT)
Prior art keywords
inspiration
control unit
flow
breathing
pump
Prior art date
Application number
PCT/NL2008/050298
Other languages
English (en)
Inventor
Robert Schot
Peter Jan Sterk
Dirk Teunis Van Der Plas
Annelies Margaretha Slats
Original Assignee
Publiekrechteiijke Rechtspersoon Academisch Ziekenhuis Leiden H.O.D.N. Leids Universitair Medisch Centrum
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 Publiekrechteiijke Rechtspersoon Academisch Ziekenhuis Leiden H.O.D.N. Leids Universitair Medisch Centrum filed Critical Publiekrechteiijke Rechtspersoon Academisch Ziekenhuis Leiden H.O.D.N. Leids Universitair Medisch Centrum
Publication of WO2008143506A1 publication Critical patent/WO2008143506A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/085Measuring impedance of respiratory organs or lung elasticity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/087Measuring breath flow

Definitions

  • the present invention relates to a device for testing and determining lung function parameters, a device for calibrating lung function apparatus, a method for treating lung patients, a method for determining lung function parameters, and a computer software product for such a device or method.
  • Lung function apparatus are known. These apparatus provide full forced artificial respiration. Some of these apparatus even provide the possibility to assist a patient in breathing. All these apparatus operate in a continuous mode. Most of these devices produce or reproduce pre-recorded flow patterns.
  • the invention aims to provide a versatile device for testing lung function parameters, as well as computer software to provide such a device.
  • a device for testing or measuring the lung function in a subject comprising a pump for providing a gas flow, an actuator for driving said pump, a sensor for determining a flow parameter of said gas flow, and a control unit, operationally coupled to said sensor for receiving at least one flow parameter from said sensor and operationally coupled to said actuator for controlling said actuator, said control unit having a processor and software for calculating a passive inspiration manoeuvre following an active inspiration manoeuvre using said flow parameters.
  • a device was developed with software which allows an object to breath freely, and which adapts to the breading pattern. At an inspiration of the object, the device provided an additional flow which naturally follows the normal breading pattern of an object, but forces an additional amount of air into the lungs of an object.
  • the device can adapt its operation to an individual object having its specific lung volume and breathing frequency. Using this device, it has proven possible to measure lung parameters in a reproducible and comparable way, making it possible not only to measure parameters of a single object, but to produce parameters which made it possible to compare various objects. This also made it possible to use the device for calibration and quality control purposes.
  • the passive inflation using the device of the invention even allows a widening of the airways more and better than possible with active maximum inspiration by an object. In for instance Asthma patients, this also showed a beneficial effect.
  • the invention further relates to a device for calibrating a lung function apparatus or respirator, said device comprising a pump for providing a gas flow, an actuator for driving said pump, a sensor for determining a flow parameter of said gas flow, and a control unit, operationally coupled to said sensor for receiving at least one flow parameter from said sensor and operationally coupled to said actuator for controlling said actuator, said control unit having a processor and software for simulating a passive inspiration manoeuvre, said pump having an outlet which is operationally couplable to an outlet of said apparatus or respirator.
  • the invention further relates to a method for treating a lung patient, in particular an asthma patient, using the device described above, comprising determining the vital capacity, expiratory reserve volume and inspiratory capacity of the patient, entering said parameters into the control unit of the device, and said software determining the functional residual volume level, the expiratory reserve volume and calculating the specific inspiratory capacity from this value, determining inspiration time and breathing frequency, said control unit controlling said actuator to follow the breathing of the patient during at least several breathings, and after these breathings to provide a machine assisted deep inspiration, said software calculating the required flow of said pump during breathing.
  • said software calculates from said flow parameters the volume displacement of said pump during active breathing for following said active inspiration, and provides instructions to said actuator for said driving said pump.
  • said software calculates several volume displacement parameters during active inspiration. In an embodiment, said software calculates an FRC level during a first active breathing phase, an inspiratory volume during another active breathing phase, and an inspiration time during yet another breathing phase.
  • said software calculates the flow of said passive inflation based on the calculated FRC level, and inspiratory volume and inspiration time. In an embodiment, said software calculates the flow of said passive inflation as a continuation of an active inspiration.
  • said device further comprises a breathing attachment for allowing a subject to breath through, an inlet for air, coupled to said breathing attachment and provided with a valve which is operable by said control unit, a duct provided with a further valve which is operable by said control unit, said duct coupling said pump to said breathing attachment, and a further inlet for air, coupled to said pump and provided with yet another valve which is operable by said control unit, and wherein said sensor is positioned to provide flow parameters of a flow through said breathing attachment.
  • said device is further coupled to an FOT-unit via control valves which are operationally coupled to said control unit, for selectively operationally coupling said FOT device to said breathing attachment.
  • the invention further relates to a method for measuring the lung condition in a subject using the device of the invention, wherein said device further comprising a breathing attachment for allowing a subject to breath through, an inlet for air, coupled to said breathing attachment and provided with a first valve which is operable by said control unit, a duct provided with a second valve which is operable by said control unit, said duct coupling said pump to said breathing attachment, and a further inlet for air, coupled to said pump and provided with a third valve which is operable by said control unit, and said sensor is positioned to provide flow parameters of a flow through said breathing attachment, and said method comprising the subsequent steps of:
  • control unit opening said first and third valve and closing said second valve;
  • software determining subject-specific parameters of functional residual volume level, the expiratory reserve volume and calculating the specific inspiratory capacity from this value, and determining inspiration time and breathing frequency using measurement values of said sensor;
  • control unit opening said second valve and closing said first and second valve
  • the invention further relates to a computer software product for calculating a passive inspiration manoeuvre following an active inspiration manoeuvre in a device described above and using said flow parameters, said computer software comprising instructions for calculation a flow pattern using measured flow parameters.
  • Fig. 1 a graph showing an example of several phases of breathing using in the device of the invention
  • fig. 2 a schematic layout of the coupling of a device of the invention coupled to an FOT device
  • fig. 3 a more detailed schematic layout of a device of the invention
  • fig. 4 a drawing of a device of the invention
  • fig. 5 a functional layout of a calibration and testing setup using a device of the invention
  • fig. 6 an alternative layout of a calibration and testing setup using a device of the invention
  • fig. 7 another alternative layout of a calibration and testing setup using a device of the invention
  • fig. 8 a schematic and functional layout of the motion control and motor for driving the pump
  • fig. 10 a time lime of measurements during a test; fig. 11 resulting measurements of an intact response group of test objects; fig. 12 resulting measurements of an impaired response group of test objects; fig. 13 a schematic layout of a device for measuring lung function of an object.
  • the motorized syringe system was built up from two 3 [L] syringes (Jaeger Manual
  • Calibration Syringe driven by a linear servomotor (Copley linear actuator TB2508, with Renishaw Optical encoder RGH24), controlled by a motion controller (Galil
  • Motion Controller DMC 1810) and powered by a digital servo amplifier (Elmo CORNET-9/230).
  • Figure 4 shows a picture of this device.
  • Equation 1 shows the formula used to calculate the volume displacement. The points for volume displacement were recalculated to motor counts, where one motor count equals 1 [ ⁇ m] motor displacement, and 0,0157 [ml] volume displacement. These volume displacements were realized with an interval of 8 [ms].
  • n Index of volume displacement point
  • V DISPL ( ⁇ ) Volume displacement for index n
  • phase P2 (see fig. 1) ERV, was measured, by a complete expiration until a plateau was reached, followed by tidal breathing.
  • the ERV was calculated from the volume difference between last end-expiratory value and the plateau of the ERV manoeuvre.
  • the specific inspiratory capacity was calculated by subtracting the ERV value from the previously measured VC.
  • As safety precaution we used ninety percent of this volume as the volume for the passive deep inspiration.
  • phase P3 see fig. 1 both inspiration time as well as breathing frequency were determined. This was done, to calculate the inspiration time for the passive deep inspiration, which was the mean inspiration time of five tidal inspirations multiplied by 1.5.
  • Phase P4 (see fig.
  • valves state B was used (figure 2), so that only air could move from the motorized syringe into the patient.
  • the speaker inside the FOT-device which produces sinus waves for the resistance measurements, may damage during the passive deep inspiration manoeuvre, due to the volume forced by the motorized syringe. Therefore, we closed the air passage to the speaker during the passive deep inspiration manoeuvre, prohibiting respiratory resistance data measurements during the passive deep inspiration.
  • the valves changed back to state A, enabling respiratory resistance measurements already during the expiration following the manoeuvre. Valves were switched on and off by digital output channels of the motion controller board.
  • Deep inspirations can reverse induced bronchoconstriction in healthy subjects. In patients with asthma this bronchodilatory effect of deep inspirations is impaired. Decreased strain transmission from the parenchyma to the airways during lung inflation, either by airway wall thickening or loss of alveolar attachments, could be a reason for this observation. Another possibility is that the airways are stretched by the deep breath, but that the components of the airway wall respond differently to the stretch imposed on it, for example as a result of airway wall remodelling or altered airway smooth muscle properties or function. Machine assisted passive inflation of the lungs may overcome these impairments by providing adequate stretch of the airways from the inside, and therefore improve the subsequent bronchodilation.
  • Methacholine challenge see fig. 10.
  • PC50Rrs provocative concentration of methacholine (mg/ml) increasing Rrs by 50% • At 50% increase in Rrs: stop challenge + Rrs measurement with DI manoeuvre to calculate DI response (see below)
  • P4 passive inflation
  • Passive inflation of the lungs may restore the beneficial bronchodilatory effects of deep inspiration in patients with asthma, most likely providing adequate stretch to the airways leading to an altered response of the airways following the DI.
  • FIGS 5, 6 and 7 several setups are shown for using the device of the invention for calibrating or for quality control of measuring devices for lung function measurement, such as for instance a spirometer and for instance ventilators..
  • the device of the invention functions as a mechanical lung and provides an input flow to for instance a spirometer.
  • the PC compares the applied flow curve of the device (VBS) with the measured graph of the spirometer.
  • the device sends its data of the applied flow curve of the VBS to a PC which is coupled to a network.
  • the spirometer is operationally coupled to another PC which is also coupled to a network. Measured results are placed in databases which can be compared.
  • Figure 7 shows an embodiment in which the device (VBS) again produces a flow to the spirometer (S. M.) via a tube (" slang").
  • an analyst compares the applied flow and the resulting flow.
  • the device and above-described method can also be used for administering drugs in aerosol, liquid or gas form deep into the lungs of an object or a patient. Using this method and device, it is possible to reach deep areas in the lungs without any uncomfortable procedures. It will be clear that the above description and drawings are included to illustrate some embodiments of the invention, and not to limit the scope of protection. Starting from this disclosure, many more embodiments will be evident to a skilled person which are within the scope of protection and the essence of this invention and which are obvious combinations of prior art techniques and the disclosure of this patent.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (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)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un dispositif pour tester la fonction pulmonaire dans un sujet, comprenant une pompe pour fournir un flux gazeux, un actionneur pour entraîner ladite pompe, un détecteur pour détecter un paramètre de flux dudit flux gazeux, et une unité de commande, couplée de manière opérationnelle audit détecteur pour recevoir au moins un paramètre de flux provenant dudit détecteur et couplée de manière opérationnelle audit actionneur pour commander ledit actionneur, ladite unité de commande ayant un processeur et un logiciel pour calculer une manœuvre d'inspiration passive suivant une manœuvre d'inspiration active à l'aide desdits paramètres de flux.
PCT/NL2008/050298 2007-05-21 2008-05-21 Dispositif de test et d'étalonnage WO2008143506A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US92456507P 2007-05-21 2007-05-21
US60/924,565 2007-05-21

Publications (1)

Publication Number Publication Date
WO2008143506A1 true WO2008143506A1 (fr) 2008-11-27

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4448058A (en) * 1982-07-02 1984-05-15 Sensormedics Corporation Respiratory gas analysis instrument having improved volume calibration method and apparatus
EP0215433A2 (fr) * 1985-09-13 1987-03-25 Luciano Gattinoni Appareil de mesure de la pression et du volume pulmonaire
WO2002066113A1 (fr) * 2001-02-20 2002-08-29 3M Innovative Properties Company Procede et systeme servant a reguler le debit d'air d'un respirateur
WO2003037436A1 (fr) * 2001-11-01 2003-05-08 Scott Health And Safety Oy Procede et dispositif d'etalonnage du volume d'air fourni par un respirateur
EP1586344A2 (fr) * 1999-06-30 2005-10-19 University of Florida Research Foundation, Inc. Système de commande de ventilateur
WO2007026367A2 (fr) * 2005-09-02 2007-03-08 Technion Research And Development Foundation Ltd. Procede et dispositif de surveillance du volume pulmonaire

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4448058A (en) * 1982-07-02 1984-05-15 Sensormedics Corporation Respiratory gas analysis instrument having improved volume calibration method and apparatus
EP0215433A2 (fr) * 1985-09-13 1987-03-25 Luciano Gattinoni Appareil de mesure de la pression et du volume pulmonaire
EP1586344A2 (fr) * 1999-06-30 2005-10-19 University of Florida Research Foundation, Inc. Système de commande de ventilateur
WO2002066113A1 (fr) * 2001-02-20 2002-08-29 3M Innovative Properties Company Procede et systeme servant a reguler le debit d'air d'un respirateur
WO2003037436A1 (fr) * 2001-11-01 2003-05-08 Scott Health And Safety Oy Procede et dispositif d'etalonnage du volume d'air fourni par un respirateur
WO2007026367A2 (fr) * 2005-09-02 2007-03-08 Technion Research And Development Foundation Ltd. Procede et dispositif de surveillance du volume pulmonaire

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