WO2007088255A1 - Device for delivering a quantity of additional respiratory oxygen - Google Patents

Device for delivering a quantity of additional respiratory oxygen Download PDF

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Publication number
WO2007088255A1
WO2007088255A1 PCT/FR2006/051349 FR2006051349W WO2007088255A1 WO 2007088255 A1 WO2007088255 A1 WO 2007088255A1 FR 2006051349 W FR2006051349 W FR 2006051349W WO 2007088255 A1 WO2007088255 A1 WO 2007088255A1
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WO
WIPO (PCT)
Prior art keywords
patient
oxygen
amount
control device
pressure
Prior art date
Application number
PCT/FR2006/051349
Other languages
French (fr)
Inventor
Bernard Carron
Bruno Fournier
Noureddine Kissi
Original Assignee
L'Air Liquide Société Anonyme pour l'Etude et l'Exploitation des Procédés Georges Claude
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.)
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Publication date
Application filed by L'Air Liquide Société Anonyme pour l'Etude et l'Exploitation des Procédés Georges Claude filed Critical L'Air Liquide Société Anonyme pour l'Etude et l'Exploitation des Procédés Georges Claude
Publication of WO2007088255A1 publication Critical patent/WO2007088255A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A61B5/0836—Measuring rate of CO2 production
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A61M16/0677—Gas-saving devices therefor
    • 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. mouth-to-mouth respiration; 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
    • A61M16/101—Preparation of respiratory gases or vapours with O2 features or with parameter measurement using an oxygen concentrator
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • 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
    • A61M2202/0208—Oxygen
    • 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
    • A61M2202/03—Gases in liquid phase, e.g. cryogenic liquids
    • 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
    • A61M2230/202—Blood composition characteristics partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
    • 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
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)

Definitions

  • the present invention relates to a device for dispensing an amount of supplemental respiratory oxygen.
  • the invention relates to a device for supplying an amount of supplemental breathing oxygen comprising an oxygen source, a circuit for conveying supplemental oxygen from the source to a patient, and means for generating a variable amount of oxygen from the source in the circuit to enable delivery of a determined amount of oxygen to the patient.
  • the management of a number of respiratory diseases is done with the help of oxygen therapy.
  • the patient is connected to a device for delivering a quantity of supplemental respiratory oxygen.
  • Known oxygen delivery devices include a source of oxygen, such as, for example: a concentrator, a pressurized oxygen gas cylinder, or a fixed or portable liquid oxygen reservoir.
  • the oxygen source generally has an oxygen flow control system typically between 0.25 and 6 L / min. This flow is delivered to the patient by the device using a telescope, which allows the patient to breathe a mixture of ambient air and additional oxygen.
  • the rate and / or volume of supplemental oxygen delivered to the patient may be continuous or pulsed.
  • the oxygen delivered during the expiratory phase of the patient is largely lost, resulting in a greater oxygen consumption than necessary.
  • the pulsed flow makes it possible to remedy this disadvantage by means of a demand valve, which uses a pressure measurement at the level of the nostrils to detect the inspiratory and expiratory phases of the patient.
  • the device delivers oxygen only during the inspiratory phase (and possibly during part of the inspiratory phase).
  • the doctor's prescription usually includes two flow figures, one for rest, the other for effort.
  • the patient intervenes manually on his oxygen therapy device to adjust the flow according to his needs.
  • valves on demand In the case where the device delivers a flow of oxygen pulsed by means of a valve on demand, there are other disadvantages.
  • one of the problems posed by valves on demand is the risk of non-detection of the patient's inspiratory call, which can in some cases become very low, especially during sleep. This has the consequence of causing the cessation of oxygen delivery.
  • one solution consists in providing that the device switches from a "pulsed" operating mode to a “continuous” operating mode as soon as the oxygen saturation of the detected patient is lower than a given threshold.
  • This solution also has disadvantages and in particular its lack of progressiveness (only two modes of operation are proposed).
  • these devices require an additional sensor to measure the oxygen saturation (SaO 2 ) of the patient.
  • these devices adapt with a certain delay, in fact, the fall of SaO 2 is one of the last sign of lack of oxygen to appear in a patient.
  • the device for delivering a quantity of supplementary respiratory oxygen which moreover complies with the generic definition given in the preamble above, is essentially characterized in that it comprises means for determining the pressure in the circuit coupled to a control device, the control device determining the respiratory rate of the patient as a function of the pressure in the circuit and controlling the generation means to regulate the quantity of oxygen of supplement delivered to the patient (eg flow and / or delivered volume) according to the determined respiratory rate.
  • the invention may include one or more of the following features:
  • control device determines the ratio between the durations of the inspiratory and expiratory phases of the patient as a function of the pressure in the circuit, the device controls the generating means for regulating the amount of supplemental oxygen delivered to the patient as a function of this ratio between the durations of the inspiratory and expiratory phases of the patient,
  • control device generates a control signal representative of a variation in the ratio of the inspiratory and exhalation phases of the patient with respect to a predetermined ratio, for regulating and adjusting the amount of supplemental oxygen to the patient's needs;
  • control device generates a control signal representative of a variation in respiratory rate determined with respect to a predetermined respiratory rate, for regulating and adjusting the amount of supplemental oxygen to the patient's needs, when the respiratory frequency determined becomes greater than a predetermined reference respiratory rate, the control device controls the generating means so as to deliver at least a first amount of so-called "high" oxygen,
  • the control device controls the generating means so as to deliver at least a second amount of so-called "low" auxiliary oxygen
  • the means for generating a variable quantity are capable of delivering a flow rate and / or an additional volume of oxygen in the form of a pulsed or continuous signal and in that the regulation of the quantity of oxygen is performed by modulating the amplitude of at least a part of the pulsed or continuous signal
  • the circuit comprises a telescope intended to be connected to at least one nasal orifice of a patient and in that the means for determining the pressure comprises a pressure sensor sensitive to the pressure of the gases exhaled by the patient
  • the device comprises means for determining the concentration of carbon dioxide in the gases exhaled by the patient, the control device controlling the generating means for regulating the amount of supplemental oxygen delivered to the patient as a function of the concentration determined carbon dioxide,
  • the device comprises means for determining the concentration or saturation of oxygen in the blood of the patient such as a pulse oximeter, the control device controlling the generating means for regulating the amount of supplemental oxygen delivered to the patient; patient according to the determined oxygen concentration,
  • the device comprises means for determining the transcutaneous carbon dioxide concentration of the patient, the control device controlling the generation means for regulating the amount of supplemental oxygen delivered to the patient as a function of the concentration of carbon dioxide transcutaneous,
  • the means for determining the pressure in the circuit comprise a pressure sensor sensitive to the pressure in the circuit
  • the generation means are capable of delivering a variable booster flow rate in a range of authorized flows and delimited by a minimum flow rate value and a maximum flow rate value,
  • control device controls the generation means to automatically regulate the quantity of supplemental oxygen delivered to the patient (for example regulation of the volume and / or of the delivered oxygen flow rate) as a function of the parameters of the patient, the so-called high and low quantities are respective constant flow values in the case of a mode of delivery of a continuous makeup oxygen flow,
  • the so-called high and low quantities are respectively minimum and maximum flow curves in the case of a mode of delivery of a pulsed supplemental oxygen flow rate
  • the device comprises means for determining the heart rate of the patient, the control device controlling the generating means for regulating the amount of supplemental oxygen delivered to the patient as a function of the determined heart rate.
  • the invention also relates to a method of therapeutic treatment using all or part of the features described in the present text.
  • the device for supplying a quantity of supplemental respiratory oxygen comprises a high and / or low pressure oxygen source 1, for example a concentrator or a bottle of gaseous oxygen under pressure, or a fixed or portable reservoir of oxygen. liquid oxygen or any other similar source.
  • a high and / or low pressure oxygen source for example a concentrator or a bottle of gaseous oxygen under pressure, or a fixed or portable reservoir of oxygen. liquid oxygen or any other similar source.
  • the device also comprises a system 2 for generating a quantity of variable oxygen that can be controlled from the source 1.
  • the system 2 for generating a variable quantity of oxygen comprises, for example, means making it possible to vary the flow rate. and / or the volume of supplemental oxygen delivered to the patient from the source. That is to say, an input of the flow generation system 2 is connected to an output of the source 1 so as to allow the delivery of a flow rate and / or variable volume of oxygen to a circuit 6 located downstream.
  • a system 2 for generating a flow rate and / or variable volume comprises for example a mechanically or electrically controlled valve.
  • the flow generation system 2 delivers a variable flow rate and / or volume according to an analog control (continuous or with pulse width modulation: PWM "Pulse Width Modulation") or a numerical control.
  • PWM pulse width modulation
  • the control signal can be for example:
  • each instant signifying that the control signal is sampled with a period of, for example, between 1 ms and 100 ms.
  • the output of the system 2 for generating flow and / or volume is connected to a circuit 6 for conveying the oxygen flow rate to a patient.
  • the circuit 6 may conventionally comprise a pipe whose end is provided with a telescope intended to be inserted into the nostrils of the patient.
  • the device comprises means for detecting the pressure in the circuit 6, preferably at the level of the telescope.
  • a pipe 14 forms a pressure point at the level of the telescope to connect the exhaled gases with a set of 4 pressure sensors.
  • the pressure sensors 4 are associated with CO 2 sensors exhaled by the patient.
  • the analysis of the instantaneous pressure signal detected at the level of the telescope makes it possible to detect the inspiratory and expiratory phases of the patient.
  • the determination of the inspiratory and expiratory phases of the patient is performed by the set of pressure sensors and / or by a computer 3 which receives the information of the pressure sensors 4 and CO 2 .
  • the determination of the inspiratory and expiratory phases of the patient makes it possible to deduce the respiratory rate of the patient, as well as the ratio I / E (ratio between the duration of the inspiratory and expiratory phases of the patient).
  • the device comprises means 4 for measuring the CO 2 exhaled by the patient
  • a pump (not shown) may be disposed within the sensor assembly 4. During the periods when this pump is active, the pressure measurement of the sensors 4 can be disturbed (the start of the pump can inhibit the trigger or inspiratory trigger). To remedy this, the period of activation of the pump is chosen relative to the respiratory cycle of the patient so as to render inconsistent the temporary inhibition of triggering ("trigger") inspiratory.
  • the device may include a pulse oximeter (optional) for obtaining an estimate of the oxygen saturation value in the blood (SaO 2 ) as well as the heart rate of the patient.
  • this sensor 5 can be connected to the patient's ear, but it can be connected to another part of his body, such as for example a finger.
  • the device may also include a transcutaneous CO 2 sensor 8
  • the device comprises a computer 3 or the like that receives as input the signals from the sensors 4, 5 8 of pressure, exhaled CO 2 , saturation of oxygen in the blood (SaO 2 ) and transcutaneous CO 2 .
  • An output of the computer 3 is connected to the system 2 for generating flow and / or volume.
  • the computer 3 thus provides a control signal for the generator 2 of flow and / or volume.
  • the device advantageously comprises a Human Machine Interface 9
  • HMI HMI
  • the computer 3 thus also receives R input from a user via the interface 9.
  • the rate and / or volume of supplemental oxygen delivered to the patient by the generation means 2 as a function of the respiratory rate determined from the measurement 4 of pressure in the circuit 6.
  • the device may optionally use one or more of the other parameters detected (I / E ratio, expired CO 2 , oxygen saturation in the blood (SaO 2 ) and transcutaneous CO 2 ) to automatically adapt the flow rate and / u the volume of oxygen delivered.
  • I / E ratio expired CO 2
  • oxygen saturation in the blood SaO 2
  • transcutaneous CO 2 transcutaneous CO 2
  • the device preferably has two modes of use a first mode called “valve on demand” (flow of oxygen pulsed in case of appeal inspiratory detected) and a second mode called “continuous” (oxygen delivered continuously).
  • valve on demand flow of oxygen pulsed in case of appeal inspiratory detected
  • continuous oxygen delivered continuously
  • the device can automatically switch to continuous mode. This continuous mode can be maintained until a respiratory activity of the patient is again detected. Moreover, for safety in case of apnea also, in continuous mode, the measurement of CO2 is inhibited while the measurement of SaO2 continues.
  • oxygen delivery begins as soon as an inspiratory call from the patient is detected. This detection is based on the measurement 4 of pressure. The stop of the flow of the oxygen flow in "valve on demand” mode takes place (at the choice of the user)
  • the device allows an adjustment of the characteristics of the flow rate and / or the volume of supplemental oxygen delivered.
  • the user can set via the Interface 9 the two flow values, one minimum and the other maximum, between which the oxygen flow rate can be allowed to vary automatically according to the patient's parameters (respiratory rate at least).
  • the device preferably allows the choice of the shape of the administered flow rate curve, for example: a constant flow rate, or an initial pulse of large amplitude followed by a lower constant value or any other known signal.
  • the device automatically varies the oxygen flow rate by means of generation means 2 between the minimum and maximum flow rates set by the user.
  • the instantaneous value of the oxygen flow rate administered is determined by the computer 3 as a function of at least the instantaneous respiratory rate of the patient obtained via the means 4 for measuring the pressure.
  • the instantaneous value of the oxygen flow calculated and delivered to the patient in real time can also take into account the I / E ratio between the inspiratory (I) and expiratory phase times.
  • the instantaneous value of the oxygen flow rate calculated and delivered to the patient may take into account the SaO 2 measurements, and / or the detected heart rate, and / or the CO 2 concentration in the exhaled gas.
  • the computer 3 controls the increase of the supplemental oxygen flow delivered to the patient (for example a bounded proportional increase). Conversely, when the instantaneous respiratory rate of the patient decreases, the computer 3 controls the decrease of the supplemental oxygen flow delivered to the patient.
  • the computer 3 can control the increase of the supplemental oxygen flow delivered to the patient (and vice versa).
  • the increase in oxygen flow rate may, for example, be substantially proportional to the I / E ratio between the duration of the inspiratory (I) and expiratory (E) phases.
  • the computer 3 can control the increase of the flow rate. supplemental oxygen delivered to the patient (and vice versa).
  • the device may use one or more parameters to automatically regulate the flow rate and / or the volume supplement made to the patient.
  • the correlation of several parameters allows optimal regulation of the flow rate and / or the volume of oxygen.
  • the device according to the invention can regulate a rate and / or volume of supplemental oxygen delivered in continuous mode or a supplemental flow rate delivered in a pulsed manner.
  • the pressure measurement 4 serves both to trigger the valve on demand (i.e., detecting the patient's inspiratory calls) and to measure the respiratory rate.
  • the device described comprises two means for measuring the patient's CO2 level (exhaled CO2 and transcutaneous CO2). Of course, although these two CO 2 measurements are preferably used simultaneously, only one of these measurements can be used.
  • the invention while being of simple and inexpensive structure, can deliver to a patient a rate and / or volume of supplemental oxygen variable automatically, with great ergonomics of use.
  • the device according to the invention makes it possible to vary the amount of supplemental oxygen delivered to the patient as a function of one or more parameters of the patient.
  • the device may vary the delivered oxygen flow rate and / or may increase or decrease the duration of supplemental oxygen delivery (constant flow or not).
  • the duration of supplemental oxygen delivery By varying the duration of supplemental oxygen delivery, the volume and thus the amount of supplemental oxygen can be varied.
  • the invention also allows a better progressiveness and anticipation in administering an oxygen flow rate to the patient by adjusting this amount of oxygen (flow and / or volume) to the actual needs of the patient.
  • the invention is particularly suitable for portable devices.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
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Abstract

Device for delivering a quantity of additional respiratory oxygen, comprising a source (1) of oxygen, a circuit (6) designed to convey the additional oxygen to a patient, means (2) for generating a variable quantity of oxygen from the source (1) in the circuit (6), means (4) which determine the pressure (P) in the circuit (6) and are coupled to a control device (3) that determines the respiratory frequency of the patient as a function of the pressure (P) and governs the generating means (2) in order to regulate the quantity of additional oxygen delivered to the patient as a function of the respiratory frequency that is determined, characterized in that it comprises means (8) for determining the concentration of transcutaneous carbon dioxide of the patient, and in that the control device (3) governs the generating means (2) in order to regulate the quantity of additional oxygen delivered to the patient as a function of the transcutaneous carbon dioxide concentration that is determined.

Description

Dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint Device for delivering a quantity of supplemental breathing oxygen
La présente invention concerne un dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint.The present invention relates to a device for dispensing an amount of supplemental respiratory oxygen.
L'invention concerne plus particulièrement un dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint comprenant une source d'oxygène, un circuit destiné à acheminer l'oxygène d'appoint depuis la source jusqu'à un patient, et des moyens de génération d'une quantité variable d'oxygène à partir de la source dans le circuit pour permettre de délivrer au patient une quantité d'oxygène déterminée.More particularly, the invention relates to a device for supplying an amount of supplemental breathing oxygen comprising an oxygen source, a circuit for conveying supplemental oxygen from the source to a patient, and means for generating a variable amount of oxygen from the source in the circuit to enable delivery of a determined amount of oxygen to the patient.
La prise en charge d'un certain nombre de pathologies respiratoires, comme notamment la broncho-pneumopathie chronique obstructive se fait à l'aide d'oxygénothérapie. Pour cela le patient est relié à un dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint.The management of a number of respiratory diseases, such as chronic obstructive pulmonary disease, is done with the help of oxygen therapy. For this, the patient is connected to a device for delivering a quantity of supplemental respiratory oxygen.
Les dispositifs de délivrance d'une quantité d'oxygène connus comportent une source d'oxygène, telle que, par exemple : un concentrateur, une bouteille d'oxygène gazeux sous pression, ou un réservoir fixe ou portatif d'oxygène liquide.Known oxygen delivery devices include a source of oxygen, such as, for example: a concentrator, a pressurized oxygen gas cylinder, or a fixed or portable liquid oxygen reservoir.
La source d'oxygène possède en général un système de réglage du débit d'oxygène compris typiquement entre 0,25 et 6 L/min. Ce débit est délivré au patient par le dispositif à l'aide d'une lunette, qui permet au patient de respirer un mélange d'air ambiant et d'oxygène additionnel.The oxygen source generally has an oxygen flow control system typically between 0.25 and 6 L / min. This flow is delivered to the patient by the device using a telescope, which allows the patient to breathe a mixture of ambient air and additional oxygen.
Classiquement, le débit et/ou le volume d'oxygène d'appoint délivré au patient peut être continu ou puisé. Dans le cas d'un débit continu, l'oxygène délivré pendant la phase expiratoire du patient est en grande partie perdu, ce qui entraîne une consommation d'oxygène plus importante que nécessaire. Le débit puisé permet de remédier à cet inconvénient, à l'aide d'une valve à la demande, qui utilise une mesure de pression au niveau des narines pour détecter les phases inspiratoire et expiratoire du patient. Ainsi, l'appareil ne délivre de l'oxygène que pendant la phase inspiratoire (et éventuellement pendant une partie de la phase inspiratoire).Conventionally, the rate and / or volume of supplemental oxygen delivered to the patient may be continuous or pulsed. In the case of a continuous flow, the oxygen delivered during the expiratory phase of the patient is largely lost, resulting in a greater oxygen consumption than necessary. The pulsed flow makes it possible to remedy this disadvantage by means of a demand valve, which uses a pressure measurement at the level of the nostrils to detect the inspiratory and expiratory phases of the patient. Thus, the device delivers oxygen only during the inspiratory phase (and possibly during part of the inspiratory phase).
Dans le cas d'un débit continu, la prescription du médecin comporte habituellement deux chiffres de débit, l'un pour le repos, l'autre pour l'effort. Le patient intervient manuellement sur son dispositif d'oxygénothérapie pour ajuster le débit en fonction des ses besoins.In the case of continuous flow, the doctor's prescription usually includes two flow figures, one for rest, the other for effort. The patient intervenes manually on his oxygen therapy device to adjust the flow according to his needs.
Ces dispositifs connus de délivrance d'une quantité d'oxygène respiratoire d'appoint présentent cependant de nombreux inconvénients. Ainsi, l'adaptation du débit d'appoint par le patient ne permet pas d'anticiper le besoin ni même de répondre suffisamment rapidement au besoin. En effet, en général, le patient intervient pour réguler le débit qu'à partir du moment où un inconfort respiratoire est ressenti. Par ailleurs, les dispositifs connus manquent d'ergonomie, le réglage manuel étant une manipulation supplémentaire mal ressentie par les patients. De plus, le réglage de débit opéré par le patient augmente le risque d'erreur ou d'imprécision. Une erreur peut provoquer la délivrance d'un débit d'oxygène inadapté au patient. Un autre inconvénient est l'impossibilité de régler le débit pendant le sommeil du patient ce qui peut entraîner des désaturations nocturnes.These known devices for delivering a quantity of supplemental respiratory oxygen, however, have many disadvantages. Thus, the adaptation of the extra flow by the patient does not anticipate the need or even respond quickly enough to the need. Indeed, in general, the patient intervenes to regulate the flow rate from the moment when a respiratory discomfort is felt. Moreover, the known devices lack ergonomics, the manual adjustment being an additional manipulation poorly felt by patients. In addition, the flow rate adjustment made by the patient increases the risk of error or inaccuracy. An error may cause the delivery of an inadequate oxygen flow to the patient. Another disadvantage is the impossibility of regulating the flow rate during the patient's sleep, which can lead to nocturnal desaturations.
Enfin, les dispositifs connus ne permettent pas une progressivité dans l'adaptation du débit.Finally, the known devices do not allow a progressiveness in the adaptation of the flow.
Dans le cas où le dispositif délivre un débit d'oxygène puisé au moyen d'une valve à la demande, il y a d'autres inconvénients. Ainsi, un des problèmes posé par les valves à la demande est le risque de non-détection de l'appel inspiratoire du patient, qui peut dans certain cas devenir très faible, notamment au cours du sommeil. Ceci a pour conséquence de provoquer l'arrêt de l'administration d'oxygène.In the case where the device delivers a flow of oxygen pulsed by means of a valve on demand, there are other disadvantages. Thus, one of the problems posed by valves on demand is the risk of non-detection of the patient's inspiratory call, which can in some cases become very low, especially during sleep. This has the consequence of causing the cessation of oxygen delivery.
Pour résoudre cet inconvénient une solution consiste à prévoir que le dispositif commute d'un mode de fonctionnement « puisé » à un mode de fonctionnement « continu » dès que la saturation en oxygène du patient détectée est inférieure à un seuil donné. Cette solution a également des inconvénients et notamment son manque de progressivité (seuls deux modes de fonctionnement sont proposés). En outre, ces dispositifs nécessitent un capteur supplémentaire pour mesurer la saturation en oxygène (SaO2) du patient. De plus, ces dispositifs s'adaptent avec un certain retard, en effet, la chute de SaO2 est un des derniers signe de manque d'oxygène à apparaître chez un patient.To solve this drawback, one solution consists in providing that the device switches from a "pulsed" operating mode to a "continuous" operating mode as soon as the oxygen saturation of the detected patient is lower than a given threshold. This solution also has disadvantages and in particular its lack of progressiveness (only two modes of operation are proposed). In addition, these devices require an additional sensor to measure the oxygen saturation (SaO 2 ) of the patient. In addition, these devices adapt with a certain delay, in fact, the fall of SaO 2 is one of the last sign of lack of oxygen to appear in a patient.
Un but de la présente invention est de pallier tout ou partie des inconvénients de l'art antérieur relevés ci-dessus. A cette fin, le dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint selon l'invention, par ailleurs conforme à la définition générique qu'en donne le préambule ci-dessus, est essentiellement caractérisé en ce qu'il comporte des moyens de détermination de la pression dans le circuit couplés à un dispositif de commande, le dispositif de commande déterminant la fréquence respiratoire du patient en fonction de la pression dans le circuit et pilotant les moyens de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient (par exemple débit et/ou volume délivré) en fonction de la fréquence respiratoire déterminée. Par ailleurs, l'invention peut comporter l'une ou plusieurs des caractéristiques suivantes :An object of the present invention is to overcome all or part of the disadvantages of the prior art noted above. For this purpose, the device for delivering a quantity of supplementary respiratory oxygen according to the invention, which moreover complies with the generic definition given in the preamble above, is essentially characterized in that it comprises means for determining the pressure in the circuit coupled to a control device, the control device determining the respiratory rate of the patient as a function of the pressure in the circuit and controlling the generation means to regulate the quantity of oxygen of supplement delivered to the patient (eg flow and / or delivered volume) according to the determined respiratory rate. In addition, the invention may include one or more of the following features:
- le dispositif de commande détermine le rapport entre les durées des phases inspiratoires et expiratoires du patient en fonction de la pression dans le circuit, le dispositif pilote les moyens de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de ce rapport entre les durées des phases inspiratoires et expiratoires du patient,the control device determines the ratio between the durations of the inspiratory and expiratory phases of the patient as a function of the pressure in the circuit, the device controls the generating means for regulating the amount of supplemental oxygen delivered to the patient as a function of this ratio between the durations of the inspiratory and expiratory phases of the patient,
- le dispositif de commande élabore un signal de commande représentatif d'une variation de rapport entre les durées des phases inspiratoires et expiratoires du patient par rapport à un rapport prédéterminé, pour réguler et adapter la quantité d'oxygène d'appoint aux besoins du patient,the control device generates a control signal representative of a variation in the ratio of the inspiratory and exhalation phases of the patient with respect to a predetermined ratio, for regulating and adjusting the amount of supplemental oxygen to the patient's needs; ,
- le dispositif de commande élabore un signal de commande représentatif d'une variation de fréquence respiratoire déterminée par rapport à une fréquence respiratoire prédéterminée, pour réguler et adapter la quantité d'oxygène d'appoint aux besoins du patient, - lorsque la fréquence respiratoire déterminée devient supérieure à une fréquence respiratoire de référence prédéterminée, le dispositif de commande pilote les moyens de génération de façon à délivrer au moins une première quantité d'oxygène d'appoint dite « haute »,the control device generates a control signal representative of a variation in respiratory rate determined with respect to a predetermined respiratory rate, for regulating and adjusting the amount of supplemental oxygen to the patient's needs, when the respiratory frequency determined becomes greater than a predetermined reference respiratory rate, the control device controls the generating means so as to deliver at least a first amount of so-called "high" oxygen,
- lorsque la fréquence respiratoire déterminée devient inférieure à une fréquence respiratoire de référence prédéterminée, le dispositif de commande pilote les moyens de génération de façon à délivrer au moins une seconde quantité d'oxygène d'appoint dite « basse », - les moyens de génération d'une quantité variable sont aptes à délivrer un débit et/ou un volume d'appoint d'oxygène sous la forme d'un signal puisé ou continu et en ce que la régulation de la quantité d'oxygène est réalisée par la modulation de l'amplitude d'au moins une partie du signal puisé ou continu, - le circuit comprend une lunette destinée à être reliée à au moins un orifice nasal d'un patient et en ce que les moyens de détermination de la pression comportent un capteur de pression sensible à la pression des gaz expirés par le patient,when the determined respiratory rate falls below a predetermined reference respiratory rate, the control device controls the generating means so as to deliver at least a second amount of so-called "low" auxiliary oxygen, the means for generating a variable quantity are capable of delivering a flow rate and / or an additional volume of oxygen in the form of a pulsed or continuous signal and in that the regulation of the quantity of oxygen is performed by modulating the amplitude of at least a part of the pulsed or continuous signal, the circuit comprises a telescope intended to be connected to at least one nasal orifice of a patient and in that the means for determining the pressure comprises a pressure sensor sensitive to the pressure of the gases exhaled by the patient,
- le dispositif comporte des moyens de détermination de la concentration de dioxyde de carbone dans les gaz expirés par le patient, le dispositif de commande pilotant les moyens de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la concentration de dioxyde de carbone déterminée,the device comprises means for determining the concentration of carbon dioxide in the gases exhaled by the patient, the control device controlling the generating means for regulating the amount of supplemental oxygen delivered to the patient as a function of the concentration determined carbon dioxide,
- le dispositif comporte des moyens de détermination de la concentration ou saturation d'oxygène dans le sang du patient tels qu'un oxymètre de pouls, le dispositif de commande pilotant les moyens de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la concentration d'oxygène déterminée,the device comprises means for determining the concentration or saturation of oxygen in the blood of the patient such as a pulse oximeter, the control device controlling the generating means for regulating the amount of supplemental oxygen delivered to the patient; patient according to the determined oxygen concentration,
- le dispositif comporte des moyens de détermination de la concentration de dioxyde de carbone transcutanée du patient, le dispositif de commande pilotant les moyens de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la concentration de dioxyde de carbone transcutanée déterminée,the device comprises means for determining the transcutaneous carbon dioxide concentration of the patient, the control device controlling the generation means for regulating the amount of supplemental oxygen delivered to the patient as a function of the concentration of carbon dioxide transcutaneous,
- les moyens de détermination de la pression dans le circuit comportent un capteur de pression sensible à la pression dans le circuit,the means for determining the pressure in the circuit comprise a pressure sensor sensitive to the pressure in the circuit,
- les moyens de génération sont aptes à délivrer un débit d'appoint variable dans une plage de débits autorisés et délimités par une valeur de débit minimum et une valeur de débit maximum,the generation means are capable of delivering a variable booster flow rate in a range of authorized flows and delimited by a minimum flow rate value and a maximum flow rate value,
- le dispositif de commande pilote les moyens de génération pour réguler automatiquement la quantité d'oxygène d'appoint délivrée au patient (par exemple régulation du volume et/ou du débit d'oxygène délivré) en fonction des paramètres du patient, - les quantités dites haute et basse sont des valeurs de débit constantes respectives dans le cas d'un mode de délivrance d'un débit d'oxygène d'appoint continu,the control device controls the generation means to automatically regulate the quantity of supplemental oxygen delivered to the patient (for example regulation of the volume and / or of the delivered oxygen flow rate) as a function of the parameters of the patient, the so-called high and low quantities are respective constant flow values in the case of a mode of delivery of a continuous makeup oxygen flow,
- les quantités dites haute et basse sont des courbes de débit respectivement minimum et maximum dans le cas d'un mode de délivrance d'un débit d'oxygène d'appoint puisé,the so-called high and low quantities are respectively minimum and maximum flow curves in the case of a mode of delivery of a pulsed supplemental oxygen flow rate,
- le dispositif comporte des moyens de détermination de la fréquence cardiaque du patient, le dispositif de commande pilotant les moyens de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la fréquence cardiaque déterminée.the device comprises means for determining the heart rate of the patient, the control device controlling the generating means for regulating the amount of supplemental oxygen delivered to the patient as a function of the determined heart rate.
L'invention concerne également une méthode de traitement thérapeutique utilisant tout ou partie des caractéristiques décrites dans le présent texte.The invention also relates to a method of therapeutic treatment using all or part of the features described in the present text.
D'autres particularités et avantages apparaîtront à la lecture de la description ci-après, faite en référence à la figure unique qui représente une vue schématique illustrant la structure et le fonctionnement d'un dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint selon l'invention.Other particularities and advantages will appear on reading the description below, made with reference to the single figure which represents a schematic view illustrating the structure and operation of a device for delivering a quantity of respiratory oxygen from supplement according to the invention.
Le dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint comprend une source d'oxygène haute et/ou basse pression 1 , par exemple un concentrateur ou une bouteille d'oxygène gazeux sous pression, ou un réservoir fixe ou portatif d'oxygène liquide ou toute autre source analogue.The device for supplying a quantity of supplemental respiratory oxygen comprises a high and / or low pressure oxygen source 1, for example a concentrator or a bottle of gaseous oxygen under pressure, or a fixed or portable reservoir of oxygen. liquid oxygen or any other similar source.
Le dispositif comporte également un système 2 de génération d'une quantité d'oxygène variable et pilotable à partir de la source 1. Le système 2 de génération d'une quantité d'oxygène variable comprend par exemple des moyens permettant de faire varier le débit et/ou le volume d'oxygène d'appoint délivré au patient à partir de la source. C'est-à-dire qu'une entrée du système 2 de génération de débit est raccordée à une sortie de la source 1 de façon à permettre la délivrance d'un débit et/ou volume variable d'oxygène vers un circuit 6 situé en aval. Classiquement, un tel système 2 de génération d'un débit et/ou volume variable comprend par exemple une vanne commandée mécaniquement ou électriquement.The device also comprises a system 2 for generating a quantity of variable oxygen that can be controlled from the source 1. The system 2 for generating a variable quantity of oxygen comprises, for example, means making it possible to vary the flow rate. and / or the volume of supplemental oxygen delivered to the patient from the source. That is to say, an input of the flow generation system 2 is connected to an output of the source 1 so as to allow the delivery of a flow rate and / or variable volume of oxygen to a circuit 6 located downstream. Conventionally, such a system 2 for generating a flow rate and / or variable volume comprises for example a mechanically or electrically controlled valve.
Par exemple le système 2 de génération de débit délivre un débit et/ou volume variable en fonction d'une commande analogique (continue ou avec modulation de la largeur d'impulsion : PWM "Puise Width Modulation") ou d'une commande numérique.For example the flow generation system 2 delivers a variable flow rate and / or volume according to an analog control (continuous or with pulse width modulation: PWM "Pulse Width Modulation") or a numerical control.
Le signal de commande pouvant être par exemple :The control signal can be for example:
- une commande simple de type ON/OFF, auquel cas la valeur du débit d'appoint délivré dans la phase « ON » est fixe et réglée par la source 2 d'oxygène,a simple command of the ON / OFF type, in which case the value of the makeup flow delivered in the "ON" phase is fixed and regulated by the source 2 of oxygen,
- une commande de type ON/OFF indiquant en plus la valeur du débit d'appoint (constant) à appliquer à chaque cycle,- an ON / OFF type control indicating in addition the value of the extra flow rate (constant) to be applied to each cycle,
- une commande élaborée indiquant à chaque instant la valeur de débit d'appoint à appliquer, « chaque instant » signifiant que le signal de commande est échantillonné avec une période comprise, par exemple, entre 1 ms et 100 ms.an elaborate command indicating at each instant the boost rate value to be applied, "each instant" signifying that the control signal is sampled with a period of, for example, between 1 ms and 100 ms.
La sortie du système 2 de génération de débit et/ou volume est reliée à un circuit 6 destinée acheminer le débit d'oxygène à un patient. Le circuit 6 peut comprendre classiquement un tuyau dont l'extrémité est pourvue d'une lunette destinée à être insérée dans les narines du patient.The output of the system 2 for generating flow and / or volume is connected to a circuit 6 for conveying the oxygen flow rate to a patient. The circuit 6 may conventionally comprise a pipe whose end is provided with a telescope intended to be inserted into the nostrils of the patient.
Le dispositif comporte des moyens de détection de la pression dans le circuit 6, de préférence au niveau de la lunette. Par exemple, un tuyau 14 forme une prise de pression au niveau de la lunette pour relier les gaz expirés avec un ensemble 4 de capteurs de pression. De manière avantageuse, les capteurs 4 de pression sont associés à des capteurs de CO2 expirés par le patient.The device comprises means for detecting the pressure in the circuit 6, preferably at the level of the telescope. For example, a pipe 14 forms a pressure point at the level of the telescope to connect the exhaled gases with a set of 4 pressure sensors. Advantageously, the pressure sensors 4 are associated with CO 2 sensors exhaled by the patient.
L'analyse du signal de pression instantanée détectée au niveau de la lunette permet de détecter les phases inspiratoires et expiratoires du patient. La détermination des phases inspiratoires et expiratoires du patient est réalisée par l'ensemble des capteurs de pression et/ou par un calculateur 3 qui reçoit les informations des capteurs 4 de pression et de CO2. La détermination des phases inspiratoires et expiratoires du patient permet de déduire la fréquence respiratoire du patient, ainsi que le rapport I/E (rapport entre la durée des phases inspiratoires et expiratoires du patient).The analysis of the instantaneous pressure signal detected at the level of the telescope makes it possible to detect the inspiratory and expiratory phases of the patient. The determination of the inspiratory and expiratory phases of the patient is performed by the set of pressure sensors and / or by a computer 3 which receives the information of the pressure sensors 4 and CO 2 . The determination of the inspiratory and expiratory phases of the patient makes it possible to deduce the respiratory rate of the patient, as well as the ratio I / E (ratio between the duration of the inspiratory and expiratory phases of the patient).
Dans le cas où le dispositif comprend des moyens 4 de mesure de CO2 expiré par le patient, il peut être nécessaire d'aspirer du gaz expiré. Dans ce cas, une pompe (non représentée) peut être disposée à l'intérieur de l'ensemble 4 de capteurs. Pendant les périodes où cette pompe est active, la mesure de pression des capteurs 4 peut être perturbée (la mise en route de la pompe peut inhibe le trigger ou déclenchement inspiratoire). Pour y remédier, la période d'activation de la pompe est choisi par rapport au cycle respiratoire du patient de façon à rendre sans conséquence l'inhibition temporaire du déclenchement ("trigger") inspiratoire.In the case where the device comprises means 4 for measuring the CO 2 exhaled by the patient, it may be necessary to aspirate exhaled gas. In this case, a pump (not shown) may be disposed within the sensor assembly 4. During the periods when this pump is active, the pressure measurement of the sensors 4 can be disturbed (the start of the pump can inhibit the trigger or inspiratory trigger). To remedy this, the period of activation of the pump is chosen relative to the respiratory cycle of the patient so as to render inconsistent the temporary inhibition of triggering ("trigger") inspiratory.
Comme représenté, le dispositif peut comporter un oxymètre de pouls 5 (facultatif) permettant d'obtenir une estimation de la valeur de saturation d'oxygène dans le sang (SaO2) ainsi que la fréquence cardiaque du patient. Comme représenté sur la figure, ce capteur 5 peut être relié à l'oreille du patient, mais il peut être relié à une autre partie de son corps, comme par exemple un doigt. Le dispositif peut comporter également et un capteur 8 de CO2 transcutanéAs shown, the device may include a pulse oximeter (optional) for obtaining an estimate of the oxygen saturation value in the blood (SaO 2 ) as well as the heart rate of the patient. As shown in the figure, this sensor 5 can be connected to the patient's ear, but it can be connected to another part of his body, such as for example a finger. The device may also include a transcutaneous CO 2 sensor 8
(facultatif) destiné à mesurer le taux de CO2 transcutané du patient.(optional) to measure the transcutaneous CO 2 level of the patient.
Le dispositif comporte un calculateur 3 ou analogue qui reçoit en entrée les signaux en provenance des capteurs 4, 5 8 de pression, de CO2 expiré, de saturation d'oxygène dans le sang (SaO2) et de CO2 transcutané. Une sortie du calculateur 3 est reliée au système 2 de génération de débit et/ou volume. Le calculateur 3 fournit ainsi en sortie un signal de commande pour le générateur 2 de débit et/ou volume.The device comprises a computer 3 or the like that receives as input the signals from the sensors 4, 5 8 of pressure, exhaled CO 2 , saturation of oxygen in the blood (SaO 2 ) and transcutaneous CO 2 . An output of the computer 3 is connected to the system 2 for generating flow and / or volume. The computer 3 thus provides a control signal for the generator 2 of flow and / or volume.
Le dispositif comprend avantageusement une Interface Homme-Machine 9The device advantageously comprises a Human Machine Interface 9
(IHM) reliée au calculateur 3 et comportant, par exemple, des moyens de saisie, un écran tactile ou non, permettant d'entrer des réglages de paramètre et de visualiser l'état du dispositif. Le calculateur 3 reçoit ainsi également en entrée des réglages R de la part d'un utilisateur par l'intermédiaire de l'interface 9.(HMI) connected to the computer 3 and comprising, for example, input means, a touch screen or not, for entering parameter settings and to view the state of the device. The computer 3 thus also receives R input from a user via the interface 9.
Selon l'invention, le débit et/ou volume d'oxygène d'appoint délivré au patient par les moyens 2 de génération en fonction de la fréquence respiratoire déterminée à partir de la mesure 4 de pression dans le circuit 6.According to the invention, the rate and / or volume of supplemental oxygen delivered to the patient by the generation means 2 as a function of the respiratory rate determined from the measurement 4 of pressure in the circuit 6.
De façon avantageuse, le dispositif peut éventuellement utiliser un ou plusieurs des autres paramètres détectés (rapport I/E, CO2 expiré, de saturation d'oxygène dans le sang (SaO2) et CO2 transcutané), pour adapter automatiquement le débit et/u le volume d'oxygène délivré. Un exemple d'utilisation du dispositif va à présent être décrit en référence à la figure unique.Advantageously, the device may optionally use one or more of the other parameters detected (I / E ratio, expired CO 2 , oxygen saturation in the blood (SaO 2 ) and transcutaneous CO 2 ) to automatically adapt the flow rate and / u the volume of oxygen delivered. An example of use of the device will now be described with reference to the single figure.
Le dispositif possède de préférence deux modes d'utilisation un premier mode dit « valve à la demande » (débit d'oxygène puisé en cas d'appel inspiratoire détecté) et un second mode dit « continu » (oxygène délivrée de façon continue). Le choix du mode de fonctionnement peut être effectué par l'utilisateur, via l'Interface Homme-Machine 9.The device preferably has two modes of use a first mode called "valve on demand" (flow of oxygen pulsed in case of appeal inspiratory detected) and a second mode called "continuous" (oxygen delivered continuously). The choice of the operating mode can be made by the user via the Human Machine Interface 9.
Par mesure de sécurité, en cas d'apnée du patient notamment, lorsque le mode « valve à la demande » est sélectionné, et qu'aucun appel patient n'est détecté au bout d'un temps réglable, par exemple entre 10 s et 60 s, le dispositif peut commuter automatiquement en mode continu. Ce mode continu peut être maintenu jusqu'à ce qu'une activité respiratoire du patient soit à nouveau détectée. Par ailleurs, par sécurité en cas d'apnée également, en mode continu la mesure du CO2 est inhibée tandis que la mesure de Saθ2 continue.As a safety measure, especially in case of patient apnea, when the "demand valve" mode is selected, and no patient call is detected after an adjustable time, for example between 10 s and 60 s, the device can automatically switch to continuous mode. This continuous mode can be maintained until a respiratory activity of the patient is again detected. Moreover, for safety in case of apnea also, in continuous mode, the measurement of CO2 is inhibited while the measurement of SaO2 continues.
Lorsque le dispositif est en mode « valve à la demande » , l'administration de l'oxygène commence dès qu'un appel inspiratoire du patient est détecté. Cette détection est basée sur la mesure 4 de pression. L'arrêt du débit du débit d'oxygène en mode « valve à la demande » a lieu (au choix de l'utilisateur)When the device is in "demand valve" mode, oxygen delivery begins as soon as an inspiratory call from the patient is detected. This detection is based on the measurement 4 of pressure. The stop of the flow of the oxygen flow in "valve on demand" mode takes place (at the choice of the user)
- après une temporisation fixe, ou- after a fixed time delay, or
- après une temporisation dont la durée est proportionnelle à la fréquence respiratoire et/o rapport I/E du patient, ouafter a delay whose duration is proportional to the respiratory rate and / o I / E ratio of the patient, or
- dès la détection d'une expiration du patient. La fréquence respiratoire du patient et la détection de l'expiration du patient est déduite du signal des moyens 4 de mesure de la pression au niveau de la lunette.- upon detection of a patient's expiration. The respiratory rate of the patient and the detection of the patient's expiration is deduced from the signal of the means 4 for measuring the pressure at the level of the telescope.
De préférence, le dispositif permet un réglage des caractéristiques du débit et/ou du volume d'oxygène d'appoint délivré. Par exemple, l'utilisateur peut régler via l'Interface 9 les deux valeurs de débit, l'une minimum et l'autre maximum entre lesquelles le débit d'oxygène pourra être autorisé à varier automatiquement en fonction des paramètres du patient (fréquence respiratoire au moins).Preferably, the device allows an adjustment of the characteristics of the flow rate and / or the volume of supplemental oxygen delivered. For example, the user can set via the Interface 9 the two flow values, one minimum and the other maximum, between which the oxygen flow rate can be allowed to vary automatically according to the patient's parameters (respiratory rate at least).
En mode « valve à la demande », le dispositif permet de préférence le choix de la forme de la courbe de débit administré, par exemple: un débit constant, ou un puise initial d'amplitude importante suivi d'une valeur constante plus faible ou tout autre signal connu. Selon l'invention, le dispositif fait varier automatiquement le débit d'oxygène à l'aide des moyens 2 de génération entre les débits minimum et maximum réglés par l'utilisateur.In "demand valve" mode, the device preferably allows the choice of the shape of the administered flow rate curve, for example: a constant flow rate, or an initial pulse of large amplitude followed by a lower constant value or any other known signal. According to the invention, the device automatically varies the oxygen flow rate by means of generation means 2 between the minimum and maximum flow rates set by the user.
La valeur instantanée du débit d'oxygène administré est déterminée par le calculateur 3 en fonction au moins de la fréquence respiratoire instantanée du patient obtenue via les moyens 4 de mesure de la pression. La valeur instantanée du débit d'oxygène calculé et délivré au patient en temps réel peut également tenir compte du rapport I/E entre les durées des phases inspiratoire (I) et expiratoiresThe instantaneous value of the oxygen flow rate administered is determined by the computer 3 as a function of at least the instantaneous respiratory rate of the patient obtained via the means 4 for measuring the pressure. The instantaneous value of the oxygen flow calculated and delivered to the patient in real time can also take into account the I / E ratio between the inspiratory (I) and expiratory phase times.
(E) du patient. De même, la valeur instantanée du débit d'oxygène calculé et délivré au patient peut tenir compte des mesures de SaO2, et/ou de la fréquence cardiaque détectée, et/ou de la concentration de CO2 dans le gaz expiré.(E) patient. Likewise, the instantaneous value of the oxygen flow rate calculated and delivered to the patient may take into account the SaO 2 measurements, and / or the detected heart rate, and / or the CO 2 concentration in the exhaled gas.
Ainsi, lorsque la fréquence respiratoire instantanée du patient détectée augmente, le calculateur 3 commande l'augmentation du débit d'oxygène d'appoint délivré au patient (par exemple une augmentation proportionnelle bornée). Inversement, lorsque la fréquence respiratoire instantanée du patient diminue, le calculateur 3 commande la diminution du débit d'oxygène d'appoint délivré au patient.Thus, when the instantaneous respiratory rate of the detected patient increases, the computer 3 controls the increase of the supplemental oxygen flow delivered to the patient (for example a bounded proportional increase). Conversely, when the instantaneous respiratory rate of the patient decreases, the computer 3 controls the decrease of the supplemental oxygen flow delivered to the patient.
De même, lorsque le rapport I/E entre les durées des phases inspiratoire (I) et expiratoires (E) du patient augmente le calculateur 3 peut commander l'augmentation du débit d'oxygène d'appoint délivré au patient (et inversement). L'augmentation du débit d'oxygène peut par exemple être sensiblement proportionnelle au rapport I/E entre les durées des phases inspiratoire (I) et expiratoires (E).Likewise, when the I / E ratio between the inspiratory (I) and expiratory (E) phases of the patient increases the computer 3 can control the increase of the supplemental oxygen flow delivered to the patient (and vice versa). The increase in oxygen flow rate may, for example, be substantially proportional to the I / E ratio between the duration of the inspiratory (I) and expiratory (E) phases.
De la même façon, lorsque la saturation d'oxygène dans le sang (SaO2) diminue, que la fréquence cardiaque augmente ou que la concentration de CO2 dans le gaz expiré augmente, le calculateur 3 peut commander l'augmentation du débit d'oxygène d'appoint délivré au patient (et inversement).In the same way, when the saturation of oxygen in the blood (SaO 2 ) decreases, the heart rate increases or the concentration of CO 2 in the exhaled gas increases, the computer 3 can control the increase of the flow rate. supplemental oxygen delivered to the patient (and vice versa).
Ainsi selon l'invention, le dispositif peut utiliser un ou plusieurs paramètres pour réguler automatiquement le débit et/ou le volume d'appoint délivré au patient. Bien entendu, la corrélation de plusieurs paramètres permet une régulation optimale du débit et/ou du volume d'oxygène. Bien entendu, le dispositif selon l'invention peut réguler un débit et/ou volume d'oxygène d'appoint délivré en mode continu ou un débit d'appoint délivré de façon puisée.Thus according to the invention, the device may use one or more parameters to automatically regulate the flow rate and / or the volume supplement made to the patient. Of course, the correlation of several parameters allows optimal regulation of the flow rate and / or the volume of oxygen. Of course, the device according to the invention can regulate a rate and / or volume of supplemental oxygen delivered in continuous mode or a supplemental flow rate delivered in a pulsed manner.
En mode puisé, la mesure de pression 4 sert à la fois à déclencher la valve à la demande (c'est-à-dire la détection des appels inspiratoires du patient) et à mesurer la fréquence respiratoire.In pulsed mode, the pressure measurement 4 serves both to trigger the valve on demand (i.e., detecting the patient's inspiratory calls) and to measure the respiratory rate.
Le dispositif décrit comprend deux moyens de mesure du taux de CO2 du patient (CO2 expiré et CO2 transcutané). Bien entendu, bien que ces deux mesures CO2 soient utilisées de préférence simultanément, il est possible d'utiliser une seule des ces mesures seulement.The device described comprises two means for measuring the patient's CO2 level (exhaled CO2 and transcutaneous CO2). Of course, although these two CO 2 measurements are preferably used simultaneously, only one of these measurements can be used.
On conçoit donc que l'invention, tout en étant de structure simple et peu coûteuse, permet de délivrer à un patient un débit et/ou volume d'oxygène d'appoint variable automatiquement, avec une grande ergonomie d'utilisation.It is therefore conceivable that the invention, while being of simple and inexpensive structure, can deliver to a patient a rate and / or volume of supplemental oxygen variable automatically, with great ergonomics of use.
En effet, le dispositif selon l'invention permet de faire varier la quantité d'oxygène d'appoint délivré au patient en fonction d'un ou plusieurs paramètres du patient. Le dispositif peut faire varier le débit d'oxygène délivré et/ou peut augmenter ou diminuer la durée de délivrance de l'oxygène d'appoint (à débit constant ou non). En faisant varier la durée de délivrance d'oxygène d'appoint, le volume et donc la quantité d'oxygène d'appoint peut être modifiée. L'invention permet également une meilleure progressivité et anticipation dans l'administration d'un débit d'oxygène au patient en ajustant cette quantité d'oxygène (débit et/ou volume) aux besoins réels du patient. L'invention est particulièrement adaptée aux appareils portables. Indeed, the device according to the invention makes it possible to vary the amount of supplemental oxygen delivered to the patient as a function of one or more parameters of the patient. The device may vary the delivered oxygen flow rate and / or may increase or decrease the duration of supplemental oxygen delivery (constant flow or not). By varying the duration of supplemental oxygen delivery, the volume and thus the amount of supplemental oxygen can be varied. The invention also allows a better progressiveness and anticipation in administering an oxygen flow rate to the patient by adjusting this amount of oxygen (flow and / or volume) to the actual needs of the patient. The invention is particularly suitable for portable devices.

Claims

REVENDICATIONS
1. Dispositif de délivrance d'une quantité d'oxygène respiratoire d'appoint comprenant une source (1) d'oxygène, un circuit (6) destiné à acheminer l'oxygène d'appoint depuis la source (1 ) jusqu'à un patient, des moyens (2) de génération d'une quantité variable d'oxygène à partir de la source (1 ) dans le circuit (6) pour permettre de délivrer au patient une quantité d'oxygène déterminée, des moyens (4) de détermination de la pression (P) dans le circuit (6) couplés à un dispositif de commande (3), le dispositif de commande (3) déterminant la fréquence respiratoire du patient en fonction de la pression (P) dans le circuit (6) et pilotant les moyens (2) de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la fréquence respiratoire déterminée, caractérisé en ce qu'il comporte des moyens de détermination de la concentration de dioxyde de carbone transcutanée du patient et en ce que le dispositif de commande (3) pilote les moyens (2) de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la concentration de dioxygène de carbone transcutanée déterminée. A device for supplying an amount of supplemental respiratory oxygen comprising a source (1) of oxygen, a circuit (6) for conveying the supplemental oxygen from the source (1) to a patient, means (2) for generating a variable quantity of oxygen from the source (1) in the circuit (6) to enable the patient to deliver a determined quantity of oxygen, means (4) of determining the pressure (P) in the circuit (6) coupled to a control device (3), the control device (3) determining the respiratory rate of the patient as a function of the pressure (P) in the circuit (6) and controlling the generation means (2) for regulating the amount of supplemental oxygen delivered to the patient as a function of the determined respiratory rate, characterized in that it comprises means for determining the transcutaneous carbon dioxide concentration of the patient and in that the control device (3) piloting the generation means (2) to regulate the amount of supplemental oxygen delivered to the patient as a function of the determined transcutaneous carbon dioxide concentration.
2. Dispositif selon la revendication 1 , caractérisé en ce que le dispositif de commande (3) comprend un calculateur qui reçoit les informations des moyens (4) de détermination de pression et qui est conformé pour déterminer le rapport (I/E) entre les durées des phases inspiratoires (I) et expiratoires (E) du patient en fonction de la pression (P) dans le circuit (6) et en ce que le dispositif pilote les moyens (2) de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de ce rapport (I/E) entre les durées des phases inspiratoires (I) et expiratoires (E) du patient.2. Device according to claim 1, characterized in that the control device (3) comprises a computer which receives the information of the means (4) for determining pressure and which is shaped to determine the ratio (I / E) between the durations of the inspiratory (I) and expiratory (E) phases of the patient as a function of the pressure (P) in the circuit (6) and in that the device controls the generation means (2) for regulating the quantity of oxygen in the supplement delivered to the patient according to this ratio (I / E) between the duration of the inspiratory (I) and expiratory (E) phases of the patient.
3. Dispositif selon la revendication 2, caractérisé en ce que le calculateur du dispositif de commande (3) est conformé pour élaborer un signal de commande représentatif d'une variation de rapport (I/E) entre les durées des phases inspiratoires (I) et expiratoires (E) du patient par rapport à un rapport (I/E) prédéterminé, pour réguler et adapter la quantité d'oxygène d'appoint aux besoins du patient.3. Device according to claim 2, characterized in that the computer of the control device (3) is shaped to develop a control signal representative of a ratio variation (I / E) between the duration of the inspiratory phases (I) and expiratory (E) of the patient by to a predetermined ratio (I / E) to regulate and adjust the amount of supplemental oxygen to the patient's needs.
4. Dispositif selon l'une quelconque des revendications 1 à 3, caractérisé en ce que le dispositif de commande (3) est conformé pour élaborer un signal de commande représentatif d'une variation de fréquence respiratoire déterminée par rapport à une fréquence respiratoire prédéterminée, pour réguler et adapter la quantité d'oxygène d'appoint aux besoins du patient.4. Device according to any one of claims 1 to 3, characterized in that the control device (3) is shaped to develop a control signal representative of a determined variation in respiratory rate with respect to a predetermined respiratory rate, to regulate and adjust the amount of supplemental oxygen to the needs of the patient.
5. Dispositif selon la revendication 4, caractérisé en ce que le dispositif de commande (3) est conformé pour piloter les moyens (2) de génération de façon à délivrer au moins une première quantité d'oxygène d'appoint dite « haute », lorsque la fréquence respiratoire qu'il détermine devient supérieure à une fréquence respiratoire de référence prédéterminée. 5. Device according to claim 4, characterized in that the control device (3) is shaped to drive the means (2) for generating so as to deliver at least a first amount of oxygen called "high" oxygen, when the respiratory rate it determines becomes greater than a predetermined reference respiratory rate.
6. Dispositif selon la revendication 4 ou 5, caractérisé en ce que le dispositif de commande (3) est conformé pour piloter les moyens (2) de génération de façon à délivrer au moins une seconde quantité d'oxygène d'appoint dite « basse », lorsque la fréquence respiratoire qu'il détermine devient inférieure à une fréquence respiratoire de référence prédéterminée.6. Device according to claim 4 or 5, characterized in that the control device (3) is shaped to drive the generating means (2) so as to deliver at least a second amount of extra oxygen called "low" When the respiratory rate which it determines becomes less than a predetermined reference respiratory rate.
7. Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce que les moyens (2) de génération sont conformés pour pouvoir délivrer un débit et/ou un volume d'appoint d'oxygène sous la forme d'un signal puisé ou continu et en ce que la régulation de la quantité d'oxygène est réalisée par la modulation de l'amplitude d'au moins une partie du signal puisé ou continu.7. Device according to any one of the preceding claims, characterized in that the means (2) of generation are shaped to be able to deliver a flow rate and / or a booster volume of oxygen in the form of a pulsed signal or continuous and in that the regulation of the amount of oxygen is achieved by modulating the amplitude of at least a portion of the pulsed or continuous signal.
8. Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce que le circuit (6) comprend une lunette destinée à être reliée à au moins un orifice nasal d'un patient et en ce que les moyens (4) de détermination de la pression (P) comportent un capteur de pression sensible à la pression des gaz expirés et/ou inspirés par le patient. 8. Device according to any one of the preceding claims, characterized in that the circuit (6) comprises a telescope intended to be connected to at least one nasal orifice of a patient and in that the means (4) for determining the the pressure (P) comprises a pressure sensor responsive to the pressure of the exhaled and / or patient-inspired gases.
9. Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il comporte des moyens (4) de détermination de la concentration de dioxyde de carbone (CO2) dans les gaz expirés par le patient et en ce que le dispositif de commande (3) pilote les moyens (2) de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la concentration de dioxyde de carbone (CO2) déterminée.9. Device according to any one of the preceding claims, characterized in that it comprises means (4) for determining the concentration of carbon dioxide (CO 2 ) in the gas exhaled by the patient and in that the device control unit (3) controls the generation means (2) for regulating the amount of supplemental oxygen delivered to the patient as a function of the determined carbon dioxide (CO 2 ) concentration.
10. Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il comporte des moyens de détermination de la concentration ou saturation d'oxygène dans le sang10. Device according to any one of the preceding claims, characterized in that it comprises means for determining the concentration or saturation of oxygen in the blood.
(SaO2) du patient tels qu'un oxymètre de pouls et en ce que le dispositif de commande (3) pilote les moyens (2) de génération pour réguler la quantité d'oxygène d'appoint délivrée au patient en fonction de la concentration d'oxygène déterminée. (SaO 2 ) of the patient such as a pulse oximeter and that the control device (3) controls the generation means (2) for regulating the amount of supplemental oxygen delivered to the patient depending on the concentration determined oxygen.
PCT/FR2006/051349 2006-02-01 2006-12-14 Device for delivering a quantity of additional respiratory oxygen WO2007088255A1 (en)

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