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WO2008067931A2 - Procédé de mesure non invasif, dispositif correspondant et son utilisation - Google Patents

Procédé de mesure non invasif, dispositif correspondant et son utilisation Download PDF

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Publication number
WO2008067931A2
WO2008067931A2 PCT/EP2007/010279 EP2007010279W WO2008067931A2 WO 2008067931 A2 WO2008067931 A2 WO 2008067931A2 EP 2007010279 W EP2007010279 W EP 2007010279W WO 2008067931 A2 WO2008067931 A2 WO 2008067931A2
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WIPO (PCT)
Prior art keywords
tracer
hemoglobin
concentration
amount
rebreathing
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Ceased
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PCT/EP2007/010279
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German (de)
English (en)
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WO2008067931A3 (fr
Inventor
Yorck Olaf Schumacher
Kai RÖCKER
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Universitaetsklinikum Freiburg
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Universitaetsklinikum Freiburg
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Publication of WO2008067931A2 publication Critical patent/WO2008067931A2/fr
Publication of WO2008067931A3 publication Critical patent/WO2008067931A3/fr
Anticipated expiration legal-status Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/0813—Measurement of pulmonary parameters by tracers, e.g. radioactive tracers
    • 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
    • A61M16/026—Control means therefor including calculation means, e.g. using a processor specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
    • 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
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • 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
    • A61M16/0045—Means for re-breathing exhaled gases, e.g. for hyperventilation treatment
    • 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
    • A61M16/0075—Bellows-type
    • 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
    • A61M16/0078—Breathing bags
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/085—Gas sampling
    • 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
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • 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
    • A61M16/22—Carbon dioxide-absorbing devices ; Other means for removing carbon dioxide
    • 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
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0036—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the breathing tube and used in both inspiratory and expiratory phase
    • 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
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • 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
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • A61M2016/1025—Measuring a parameter of the content of the delivered gas the O2 concentration
    • 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
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • A61M2016/103—Measuring a parameter of the content of the delivered gas the CO2 concentration
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • A61M2202/0233—Carbon monoxide
    • 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
    • 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
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation

Definitions

  • the invention relates to a method (or method) for obtaining measurement data suitable for determining the total amount of hemoglobin of a lung respirator, in which a predetermined dose of a breathable tracer is adjusted and noninvasively delivered through a body mucosa of the lung respirator; and devices useful in the method, and corresponding uses, and tracers for related applications.
  • the blood of pulmonary breaths (terrestrial animals like humans) consists of blood cells and plasma.
  • the proportion of blood cells in the total blood volume is also called the volume of erythrocytes because the red blood cells dominate. Closely associated with this size is the total amount of hemoglobin in the organism, which plays a crucial role in the transport of oxygen in the body.
  • Organism mostly taken from the concentrations of hemoglobin and hematocrit. However, since these are purely proportional measures, they are extremely error-prone. Thus, e.g. In acute bleeding, a blood loss of several liters occur without changing hemoglobin concentration or hematocrit.
  • a tracer which in the present disclosure preferably means a trace substance that can be tracked by measurement
  • a radioactive material eg, 51 chromium, 125 iodine, radiolabelled iron
  • a staining or fluorescent dye eg Evans Blue
  • the concentration of this material in a subsequently taken blood sample is, after complete distribution in the blood, inversely proportional to the height of the blood volume.
  • Radioactive methods are used so far.
  • the disadvantages are, in addition to the radioactivity, which requires special measures and expensive radioactive substances in the invasiveness: As a rule, blood is removed, radioactively labeled and reinfused. This procedure is expensive, complex in terms of equipment and personnel and time-consuming, so that it is used only in radiological departments. For the patient, it is very stressful and involves not insignificant risks as a result of radioactive radiation and infections in the puncture through the skin.
  • CO-Hb carboxyhemoglobin
  • the amount of CO used is extremely low (it corresponds to the amount of CO emitted when smoking)
  • a two-minute respiratory procedure is sufficient to bind the majority of the CO introduced in the experiment in the blood before and immediately after the breathing procedure becomes too accurate Blood is withdrawn at defined times and the CO-Hb content determined laboratory-chemically.
  • the determination of the total body hemoglobin amount is then carried out taking into account the amount of CO inhaled and physi cal factors, such as air pressure and temperature, via the measurement of
  • the object of the invention is to find a method and devices for determining measured values in a simple manner and for Determination of the total body hemoglobin amount can be used.
  • One or more of the following features should be realized: the least possible expenditure on equipment, the lowest possible burden on the organism to be tested (for example, by avoiding radioactivity and repeated blood withdrawals), sufficient accuracy, simple feasibility, even in the case of injured or weakened subjects , and / or largely automatic detection of whole body hemoglobin, as well as rapid feasibility.
  • the object is achieved by a method mentioned at the outset or corresponding devices which are characterized or make it possible to record and / or (preferably) eliminate the abatemable tracer by non-invasive measurement of a parameter correlated with the amount of tracer in the body of the lung respirator a plurality of points in time during a breath is determined and preferably one or more of the further method steps mentioned below are performed.
  • the hemoglobin mass can be non-invasively, i. without blood collection, to be determined.
  • Hb hemoglobin
  • the invention relates to a noninvasive method for obtaining measurement data suitable for determining the total hemoglobin amount of a lung respirator in which a predetermined dose of a breathable tracer is adjusted and noninvasively delivered through a body mucosa of the lung respirator and the uptake and / or
  • the elimination of the breathable tracer is determined by non-invasive measurement of a parameter correlated with the amount of tracer in the body of the lung respirator at a plurality of times.
  • This method is preferably used using appropriate computerized methods for the automatic determination of whole body hemoglobin to achieve automation.
  • Methods according to the invention can be used for the pure acquisition of measurement data, from pure measurement signals via parameters correlated for example with the concentration of the tracer to the preferred determination of total body hemoglobin (total body hemoglobin mass) or other measurement data as defined below.
  • the measurement data can be used in further steps for various purposes: for example, for the mere determination of the general physical status with respect to the BacConsequentlyhogoglobinmasse without curative purposes or in the context of a diagnostic procedure, especially for medical purposes, then in particular in a first process step, a dose amount of the tracer (preferably without presence of the subject).
  • the values obtained can also be used for diagnostic purposes in the sense of a diagnostic procedure (eg for healing purposes), also for therapeutic decisions (eg in dialysis, oncology, intensive care, emergency care or the like).
  • the invention therefore also relates, as a special case to be emphasized, to a method according to the invention (in particular one in which the dosage can be made by adjusting or providing a suitable tracer dose to a used rebreathing device in the absence of the subject), the further reduction phase (In particular, assessment of the total body hemoglobin mass found and decision on another possible therapeutic approach by suitable persons, such as doctors).
  • the invention relates to a rebreathing device for the noninvasive determination of the hemoglobin mass which comprises a tracer sensor, in particular a CO sensor, having a t 90 of 500 ms or less, preferably of 250 ms or less, in particular of 150 ms or less (for example, an IR sensor, a mass spectrometer (MS), a gas chromatograph (GC) or a GC-MS combination (each suitable for the analysis of respiratory gases), or equipped for the measurement of CO-Hb pulse oximeter (suitable for determining the CO- Hb concentration in blood), or two or more of the same or different ones of these sensor devices) or included as accessories.
  • a tracer sensor in particular a CO sensor
  • a CO sensor having a t 90 of 500 ms or less, preferably of 250 ms or less, in particular of 150 ms or less
  • a tracer sensor in particular a CO sensor
  • a CO sensor having a t 90 of 500 ms or less,
  • the invention also relates to at least one TracerG Communication CO) sensor (eg as an IR sensor, as a mass spectrometer (MS), as a gas chromatograph (GC) and / or GC-MS combination) (each for measuring the tracer eg CO concentration in breathing gas) or a pulse oximeter (in particular for measuring the Hb-tracer, eg Hb-CO concentration), which / which is equipped with an evaluation unit that is programmed to determine the total body hemoglobin, in particular on the elimination of a in a tracers described above and described below.
  • the steps and calculation methods of the evaluation are implemented as in the examples (when using at least one pulse oximeter, preferably only starting from the description of the measurement data in FIGS. 5 and without consideration of a lung compartment, but optionally with consideration of other tracer or CO distribution compartments).
  • the invention also relates to carbon monoxide for use as tracer gas in the context of a non-invasive, in particular one mentioned in one of the following claims diagnostic method for determining the total body hemoglobin content of a pulmonary.
  • Non-invasive means in particular, that in a method according to the invention, no procedures are performed in violation of a surface (eg skin, mucosa) of a lung respirator by means of medical instruments or apparatus such as lancets, catheters, infusion or injection needles or the like, in particular that no blood collection takes place ,
  • a surface eg skin, mucosa
  • the mere uptake of a mouthpiece or insertion of a tube into the respiratory tract is preferably not excluded, as well as slight pressure by pulse oximeter on the skin.
  • pulmonary breathing (hereinafter also partially referred to as a subject, which stands for test person or subject) are in particular birds, amphibians, reptiles or primarily mammals, especially humans to understand.
  • a defined dose is to be understood as meaning an amount of a tracer which does not or only to a tolerable extent have a harmful effect on the subject - for example, in the case of carbon monoxide, an amount ranging from 0.2 to 5, preferably from 0.5 to 2, in particular from 0.7 to 1, 0 ml of carbon monoxide per kg of body weight of the subject.
  • This dose is preferably provided such that accidental overdosing is not possible, for example (preferably in advance) in the form of pre-fillable and then as Supply reservoir connectable or already connected chambers, pre-filled cartridges, bags, bottles or syringes or similar containers, which allow the supply of a clearly determined dose of the tracer and can be connected, for example via an open and lockable valve with a rebreathing device.
  • the evaluation of the data can be carried out without the presence of the subject. Knowledge of the exact administered dose is required for subsequent measurement and calculation.
  • a abatembarer tracer is a gaseous at temperatures in the range of 0 to 50 0 C trace substance or a precursor thereof which releases a abatembaren tracer, preferably a gas, in particular a gas, which enters with hemoglobin, a complex bond, particularly carbon monoxide (CO).
  • a gas in particular a gas, which enters with hemoglobin, a complex bond, particularly carbon monoxide (CO).
  • Non-invasive delivery via a body mucosa means, in particular, delivery via a mucous membrane of the respiratory and / or gastrointestinal tract, in particular of the lung, either by means of a dispersion or solution or preferably in gaseous form, in particular via a respiratory gas (this term includes there are also mixtures of gases).
  • the supply preferably takes place by means of a rebreathing device, since a correction for CO still present in the lungs can then be carried out in the exhaled air due to the steep initial phase of the CO decrease.
  • the noninvasive determination of the elimination of the abatembaren tracer by means of a correlated with the amount of tracer in the body of the lung breather parameter is preferably carried out (which should not exclude the removal of breathing gas from the mouth, eg via a mouthpiece or a tube) and / or on the Outside of the body of the lung respirator, in particular via a measurement of the concentration reduction of the tracer (as such) in
  • “Breathing gas” is preferably the breathing gas in a closed system near the mouth, or alternatively or additionally the exhalation gas near the mouth of the subject, in one possible preferred embodiment of the invention the end-alveolar exhalation gas may be meant, in another the inhaling and exhaling gas in one closed system near the mouth, wherein the amount of CO is then preferably integrated as shown below, so that even without consideration of the tracer concentrations only in end-alveolar expiratory gas good results can be achieved, which is a particular advantage of the process in question.
  • Determination of elimination at a plurality of times means that during each breath, at least 2 measurements, preferably 3 or more measurements, in particular 6 or more measurements, are taken.
  • the advantage of such a variety of measurements is that single measurement errors can be better averaged out
  • this can be achieved by means of a sensor for the content of tracer in the respiratory gas or a pulse oximeter having a tgo of 500 ms or less, in particular of 250 ms or less, above all of 150 ms or less (tgo is as defines the time required to register 10% to 90% of a step change in gas concentration.)
  • Time thus also means period, so preferably 2 or more measurements per second are possible, for example 4 or more measurements per second possible measurements may be due to the t90 values of the sensors or measuring instruments used borders.
  • the computer-aided (at least largely automated) determination of the total hemoglobin amount of a lung respirator from the data obtained takes place, if desired, advantageously with computer-aided smoothing of raw data, but preferably, for example, according to a "moving average” method in which, for example, the mean value is formed sequentially for a specific number of measured values (eg 10 or 20) before and / or after a measured value to be smoothed), integration (in particular eg breathable integration, wherein the respiratory tract detection is preferably carried out by means of the data of a flow meter (flow meter).
  • a flow meter flow meter
  • the tracer concentration for example, the tracer concentration, determining the time course of the tracer concentration (preferably with the aid of prior calibration, especially when eliminating the tracer) based on the integral values and application of known in principle Umrechvorschriften (for example, linear dependence of the CO concentration and the CO-Hb saturation according to equation I below) for determining the carboxyhemoglobin (CO-Hb) saturation and / or (preferably and) adaptation of curve functions (in particular also for determining distribution compartments of the tracer and their separation) and their use in arithmetic instructions for Determination of total CO-Hb (eg, including the use of the equation shown below
  • the rebreathing device preferably includes a calibration function for the CO content.
  • a calibration function for the CO content for example, the zero signal (ambient air or special breathing gas without CO) and the signal for a gas with a defined CO content (for example 50 ppm) can be determined and the difference of the resulting measured values used for calibration.
  • the rebreathing device preferably has ports or chambers which allow the tracer to be used (in particular CO) quantity from chambers or containers with a clearly metered amount of tracer, eg with tracer or tracer-containing gas mixtures pre-filled individual cartridges, prepare and administer, which increases the safety for the subjects.
  • a method according to the invention takes place between a remindatemphase (preferably about 2 minutes) and a Auswaschphase (for example, 5 to 60 minutes, eg about 10 minutes) of the abatembaren tracer preferably the automatic switching of the proband mouthpiece between remindatemreservoir and room air or O 2 supply an automatically switchable valve, eg an electronic solenoid valve.
  • a recommendatemphase preferably about 2 minutes
  • a Auswaschphase for example, 5 to 60 minutes, eg about 10 minutes
  • a possible preferred variant of the invention is the mouthpiece with the sensor unit for the tracer (in particular with a CO sensor for CO measurement), preferably with the above-preferred tgo values, from the rest of the unit removable, so that the subject is given more freedom of movement.
  • the above-mentioned automatically switchable valve between Ü 2 supply and room air can be dispensed with in the corresponding rebreathing device.
  • the respective phases of the measurement procedure are e.g. displayed on a display for the subject and / or operator of the rebreathing device, so that accordingly a preferred rebreathing device according to the invention is equipped with a corresponding evaluation module (eg in the form of a computer) with display (eg computer monitor) or used in the method according to the invention becomes.
  • a corresponding evaluation module eg in the form of a computer
  • display eg computer monitor
  • the rebreathing device according to the invention (which is then also used in the method according to the invention) contains protection mechanisms to protect against unfavorable gas conditions (for example, the oxygen concentration should not be too low, the carbon dioxide concentration should not rise too high). Therefore, it is preferably provided that when exceeding thresholds in an emergency even during the rebreathing phase, a valve for Room air is automatically opened.
  • unfavorable gas conditions for example, the oxygen concentration should not be too low, the carbon dioxide concentration should not rise too high. Therefore, it is preferably provided that when exceeding thresholds in an emergency even during the rebreathing phase, a valve for Room air is automatically opened.
  • the measurement of its concentration is preferably breathable (for example, by integration of several measured values during a breath) . This enables accurate automatic analysis of the washout kinetics.
  • a further preferred embodiment of the invention relates to the computational (computer-aided) implementation of an integration of the determined tracerderi fourth measurement signals (sensor signals) of Auswaschkinetiken and (which is particularly necessary when measuring the CO concentration via a CO sensor of exhaled CO) a computational separation the proportion of different CO binding compartments, in particular the lung and blood portion of the applied CO, preferably by finding adapted functions (fitting) and decomposition of superimposed functions in individual functions. As a result, an accurate distribution of CO in the system can be calculated.
  • Fig. 1 Schematic representation (in cross section) of an inventively applicable and inventive rebreathing device. The arrow indicates the direction of the airflow when inhaling a subject.
  • Fig. 2 Graphic representation (detail) of the CO signal at the mouth as a function of time in the washout phase (elimination phase of the CO in open system). The abscissa (x-axis) is the time (min), the ordinate (y-axis) is the CO signal (V).
  • Fig. 3 Graphical representation (detail) of the CO signal as a function of time in the washout phase with curve for breath-integrated CO signal. Values on abscissa and ordinate as in FIG. 2.
  • FIG. 5 Graphical representation of the CO-hemoglobin (CO-Hb) saturation (% of Hb 1 present as CO-Hb) determined from the CO concentrations in FIG. 4 over time.
  • FIG. 6 Graphical representation of the adaptation (fitting) to falling exponential functions for the CO elimination from the two main compartments.
  • Fig. 7 Schematic representation of another vomatmungsvoutter according to the invention with fixed or removable unit mouthpiece and measuring sensors (if this unit is removable, the rebreathing device can also be designed without the valve 10 shown, the Clippings A and B show the path of the air when opening the way to the room air (A) or the remindatemreservoir (B)).
  • a mouthpiece 2 is adjoined by an area with measuring sensors and / or devices 3 (in particular a CO sensor and a flow meter, also other sensors or measuring devices such as oxygen or CO 2 sensors or measuring devices are possible here), followed by a CO 2 - Absorption chamber 4.
  • An attachment 5 allows the connection to a CO applicator (for example, a cartridge or a syringe with a defined CO-
  • the CO supply is controlled by a valve 6, which is opened for CO supply, while another valve 7, the connection to a remindatemreservoir 8, for example in the form of a so-called Douglassack, which may have, for example, an internal volume of 3 I.
  • the valves 6 and 7 may be embodied, for example, coupled, so that the valve 7 can be opened with a time delay after the valve 6, for example as a coupled, automated vacuum valve system 9 with flow / volume meter.
  • Another valve 10 may allow the supply of fresh air or oxygen.
  • the data of the measuring sensors and / or devices in the area 3 and the control of the valves can via a (multi-component executable) evaluation module 11 (which may include a control, for example, the CO dosage, the valves and other relevant components of the rebreathing device 1 and
  • a connectable computer can be executed and preferably the necessary programs, in particular for the implementation of the following calculation rules (eg, the formulas and algorithms, as given below), includes) collected and evaluated or made.
  • Fig. 7 shows a variant in which instead of the Douglassackes as mulchatemreservoir 8 (here accordion-like expandable) bellows is provided, allowing a simpler determination of the volume (for example, by measuring the height of the bellows or a parallel calibrated display) in the rebreathing reservoir, thus allowing easier correction for uninflated CO in the rebreathing device.
  • valve 10 can be omitted, namely, if a separation area 24 (eg, as aufsteckbares on or in the remaining area of the connector with the mouthpiece 2) is provided - then the mouthpiece with the measuring sensors and devices 3 can be separated from the rest of the rebreathing device after inhaling the CO 5 and CO exhalation can be performed without these other components, which can allow high mobility for a subject.
  • the separation region 24 may be provided and yet a valve 10, or the separation region 24 may be omitted entirely and then a valve 10 may be provided to switch between room air and air in the rest of the rebreathing device.
  • a computer 23 (corresponding to the evaluation module 11 in FIG. 1) enables the collection and evaluation of the data.
  • the CO sensor one having a tgo of 500 ms or less, for example, 250 or, preferably, 125 ms, is used, or is provided in the device, to allow a plurality of measured values to be obtained, for example advantageously a correspondingly equipped IR -Sensor. This can for example be equipped so that an aliquot of the gas flowing through the device is branched off and supplied to the actual sensor.
  • Standard gas eg, 50 ppm CO
  • room air or CO-free standard gas (0 ppm)
  • the rebreathing device 1 can be set up to dose a certain amount of CO, for example by attaching a cartridge, bottle, syringe, bag, chamber or other containing a suitable predetermined amount of CO Container, pumping of such an amount or the like.
  • Suitable amounts of CO are 0.7 to 1.0 ml per kilogram body weight of the subject.
  • the rebreathing device is filled with a suitable breathing gas, such as pure oxygen. This filling can also be done without the presence of the subject.
  • a subject is connected via the mouthpiece 2 (alternatively, for example, a tube would be possible) connected (if he is not already connected in the previous steps).
  • a first step the subject breathes through the area with measuring sensors and / or devices 3 with the valve 10 open (or, if a separation area 24 is present, with mouthpiece 2 and measuring sensors and devices 3 and 2 connected to the rest of the rebreathing device) open) valve 10), for example, 10 breaths quietly on and off.
  • the valve 10 open (or, if a separation area 24 is present, with mouthpiece 2 and measuring sensors and devices 3 and 2 connected to the rest of the rebreathing device) open) valve 10), for example, 10 breaths quietly on and off.
  • the rebreathing device 1 which is previously filled, for example, with pure oxygen or air, the previously set body weight-adapted amount of CO, via e.g. about 2 minutes in the closed
  • the continuous registration of the breaths over, for example, 10 minutes takes place analogously to the measurement before Application of the carbon monoxide with the valve 10 open and / or with the use of a possibly existing separation region 24 removed unit mouthpiece 2 and measuring sensors and devices 3.
  • the necessary (CO concentration, flow) and possibly optional data are collected (for example if only the end-alveolar concentration of CO is to be measured, this is determined by parallel determination of the CO 2 concentration (for example by gas chromatography), which is also highest in the end-alveolar gas, and by the corresponding CO concentration measurements be correlated). In the example described further below not only the end-alveolar, but the CO concentration is used during the entire breath.
  • raw data (signals) 12 are obtained (FIG. 2) which, as shown here, can advantageously be smoothed by a so-called “moving-averaging” method (for example, by in each case one data window of 20 values each)
  • the measurement signal (hereinafter also referred to as V) of the sensor is applied.)
  • the CO concentration can now be determined automatically by computer-aided breathing (FIG Signals (V) are here integrated (Fig. 3) in the device itself Breathable (“Breath-by-Breath”) computer-aided.
  • Curve 14 corresponds to the uncalibrated, breath-integrated CO signal.
  • the breath detection is based, for example, on the analysis of the signal, not shown here, for the flow of breathing gas (Flow, l / s).
  • the values for the breath-by-breath course of the expiratory CO concentration [CO] are determined computer-assisted (FIG. 4).
  • every data point represented corresponds to one breath over time (time (min)).
  • CO-Hb saturation can be graphically (or computationally) represented
  • the leaching of CO from the organism after the rebreathing phase when measuring the CO in the respiratory gas is mainly made up of two compartments:
  • Fig. 6 illustrates the non-linear modeling of leaching two compartments according to the general equation II, obtained here using eg the Levenberg-Marquardt algorithm (other adaptation algorithms would also be usable, such as the Gauss-Newton algorithm or the method of gradient descent) ):
  • CO-Hb (%) Asiut ' e " ⁇ Blood ⁇ ⁇ + A Lung ⁇ ⁇ e " ALunge ⁇ + s (II)
  • t is the time after completion of the rebreathing phase and s is the reference value for the CO-Hb (%) fraction of total Hb before CO administration.
  • a and ⁇ are the respective macro parameters of the blood and lung washout functions.
  • Fig. 6 can be clearly distinguished between the two main compartments of the CO distribution in the rebreathing phase (blood compartment, fitted curve 18, lung compartment: fitted curve 19), the straight line 20 stands for the reference value for CO-Hb (%) before the beginning of CO application.
  • a generally valid reference for the calculation of the Hb mass represents the size A B iut 21.
  • the values thus obtained permit a calculation of the hemoglobin mass: Based on the increase in CO-Hb saturation during the rebreathing phase, which can be determined by the measurement data, at an optimized time, the amount of hemoglobin mass is determined from the administered CO amount, for example, according to equation III (Schmidt et al., Eur. J. Physiol. 95 (5-6): 486-95, 2005, and Bürge et al., J. Med.
  • Hb mass (g) K ⁇ D co '100 • ( ⁇ HbCO% ⁇ 1, 39) "1 (III) Barometric pressure (mm Hg) • 273 0 K)
  • Dco is the applied CO dose
  • ⁇ HbCO% is the increase in HbCO (%) (increase in absolute%) by the rebreathing phase and 1
  • 39 is the Hüfner number (measure how much ml of oxygen or carbon monoxide can bind a gHb ).
  • the selection of the window for ⁇ HbCO% is relevant for the quality of the Hb mass calculation. Ideally, this should be the moment of maximum binding and distribution of the amount of CO inhaled in the rebreathing phase. However, this time varies due to individual CO kinetics from subject to subject. The method shown for exact numerical detection of the dynamic change is therefore suitable i.a. also for the optimization of this value.
  • D C o can be corrected according to the model shown with the amount of CO "lost" via the lung compartment according to equation V:
  • COsystem is the remaining amount of CO in the rebreathing system at the end of the experiment - this value is determined by the measured CO concentration and the (known and when using eg a bellows as mulchatemreservoir 8 as shown in Fig. 7 very easily determinable) volume of System determines. For example, this can be done by means of a shown in Fig. 1, for example, only 22, an aliquot part of the gas in the rebreathing system is directed to the measuring sensors or devices 3, where the CO concentration is determined. Other arrangements (also separate sensors for CO concentration in the rebreathing device) may alternatively be used.
  • the total body hemoglobin mass can be calculated by way of example:
  • K is calculated according to C. Bürge et al., J. Appl. Physiol. 79 (2), 623-631, 1995) at a temperature of 26.8 ° C and a barometric pressure of 735.5 mm Hg as:
  • Equation VIII After substitution in Equation III, the result for the Hb mass is obtained via Equation VIII:
  • Corresponding computing steps are computer implemented via suitable computer software in the evaluation unit 11 or the computer 24 (evaluation unit and computer are used interchangeably in the present application), so that the total body hemoglobin can be determined automatically.
  • the determination of the decrease in CO-Hb concentration can also be carried out by other noninvasive methods, for example by means of a pulse oximeter, which is also equipped for the measurement of CO-Hb. These measurements can be used, for example, to determine the general body status or for diagnostic purposes for healing purposes.

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Abstract

L'invention concerne un procédé non invasif pour l'obtention de données de mesure permettant de déterminer la quantité totale d'hémoglobine d'un sujet à respiration pulmonaire. Selon ce procédé, une dose préalablement définie d'un traceur expirable est ajustée et est amenée de manière non invasive au sujet à respiration pulmonaire par le biais d'une muqueuse corporelle de ce dernier. L'absorption et/ou l'élimination du traceur expirable sont déterminées à une pluralité d'instants par la mesure non invasive d'un paramètre corrélé avec la quantité du traceur dans le corps du sujet. L'invention concerne également un dispositif ainsi que du CO à utiliser ou l'utilisation de CO dans un procédé correspondant, diagnostique par exemple. Des règles de calcul appropriées (visualisées à la figure 6, par exemple) permettent de déterminer automatiquement le taux d'hémoglobine corporel total.
PCT/EP2007/010279 2006-12-05 2007-11-27 Procédé de mesure non invasif, dispositif correspondant et son utilisation Ceased WO2008067931A2 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009053225A1 (de) * 2009-11-06 2011-05-12 Deutsche Sporthochschule Köln Verfahren zur Bestimmung der totalen Hämoglobinmenge im Körper eines Lebewesens
CN111281400A (zh) * 2020-01-22 2020-06-16 首都医科大学宣武医院 借助于非接触式血管可视化设备的辅助操作装置及方法

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CA3047628C (fr) 2017-01-30 2023-05-16 Opco Medical Aps Dispositif servant a determiner la quantite d'hemoglobine dans le sang d'un patient

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US5022406A (en) * 1988-08-01 1991-06-11 Tomlinson Harold W Module for determining diffusing capacity of the lungs for carbon monoxide and method
US5810723A (en) * 1996-12-05 1998-09-22 Essential Medical Devices Non-invasive carboxyhemoglobin analyer
US6415236B2 (en) * 1999-11-30 2002-07-02 Nihon Kohden Corporation Apparatus for determining concentrations of hemoglobins
DE10222750C1 (de) * 2002-05-23 2003-11-06 Walter Schmidt Vorrichtung zur Inhalation einer vorgegebenen Menge an Kohlenmonoxid

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009053225A1 (de) * 2009-11-06 2011-05-12 Deutsche Sporthochschule Köln Verfahren zur Bestimmung der totalen Hämoglobinmenge im Körper eines Lebewesens
CN111281400A (zh) * 2020-01-22 2020-06-16 首都医科大学宣武医院 借助于非接触式血管可视化设备的辅助操作装置及方法
CN111281400B (zh) * 2020-01-22 2022-08-19 首都医科大学宣武医院 借助于非接触式血管可视化设备的辅助操作装置及方法

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