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WO2010059049A2 - Appareil et système de surveillance de la respiration et de la ventilation, dispositif de défibrillation, appareil et système de surveillance des compressions du torse et appareil à valves - Google Patents

Appareil et système de surveillance de la respiration et de la ventilation, dispositif de défibrillation, appareil et système de surveillance des compressions du torse et appareil à valves Download PDF

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Publication number
WO2010059049A2
WO2010059049A2 PCT/NL2009/050700 NL2009050700W WO2010059049A2 WO 2010059049 A2 WO2010059049 A2 WO 2010059049A2 NL 2009050700 W NL2009050700 W NL 2009050700W WO 2010059049 A2 WO2010059049 A2 WO 2010059049A2
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WO
WIPO (PCT)
Prior art keywords
ventilation
valve
patient
parameters
cardiac
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/NL2009/050700
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English (en)
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WO2010059049A3 (fr
Inventor
Gerardus Wilhelmus Lugtigheid
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Emergency Pulmonary Care BV
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Emergency Pulmonary Care BV
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Filing date
Publication date
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Publication of WO2010059049A2 publication Critical patent/WO2010059049A2/fr
Publication of WO2010059049A3 publication Critical patent/WO2010059049A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M16/0009—Accessories therefor, e.g. sensors, vibrators, negative pressure with sub-atmospheric pressure, e.g. during expiration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H31/00—Artificial respiration by a force applied to the chest; Heart stimulation, e.g. heart massage
    • A61H31/004—Heart stimulation
    • A61H31/005—Heart stimulation with feedback for the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3925—Monitoring; Protecting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/04—Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/20—Blood composition characteristics
    • A61H2230/207—Blood composition characteristics partial O2-value
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/30—Blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/40—Respiratory 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
    • 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
    • A61M16/0003—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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • 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
    • A61M2230/30—Blood pressure
    • 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)
    • 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
    • A61M2230/65—Impedance, e.g. conductivity, capacity

Definitions

  • the present invention relates to an apparatus for monitoring breathing or ventilation, particularly during resuscitation.
  • the invention also relates to a system comprising such an apparatus and a defibrillator. Furthermore the invention relates to a system comprising such an apparatus and a chest fixation device.
  • the invention relates to a defibrillator device.
  • Devices for monitoring ventilation during resuscitation are e.g. known from US 6,155,257, describing a cardiopulmonary ventilator comprising a chest compression sensor that is coupled to a controller, which actuates the ventilator after a certain number of compressions.
  • the disadvantage of such a system is that it does neither measure the condition of the airway nor the condition of the heart rhythm, it does not determine the optimum treatment strategy based on these measured conditions, it does not synchronize chest compression and ventilation, it does not facilitate expiration by reducing the expiration pressure, it does not in any way monitor the effect of the cardiopulmonary resuscitation and it does not give any feedback to the user.
  • the apparatus of the present invention may be interfaced with several different medical devices to monitor and control the effectiveness of mechanical or manual ventilation of the patient, particularly during resuscitation and/or signal the user in case of inadequate ventilation and/or intervene in the case of risk to the patient.
  • the apparatus of the present invention may e.g. be interfaced with a manual ventilator or a mechanical ventilator and/or a defibrillator such as an Automatic External Defibrillator ("AED") and/or a cardiopulmonary resuscitation (“CPR”) device provided with a load distributing band for delivering mechanical chest compressions, also referred to as "Auto CPR".
  • AED Automatic External Defibrillator
  • CPR cardiopulmonary resuscitation
  • a defibrillator in particular an AED, provides unambiguous feedback and instructions.
  • Existing ventilation equipment particularly manual ventilation devices such as a resuscitator or a respirator lack such feedback and instructions, due to the fact that no relevant parameters are measured.
  • the skill and stress level of the operator determine the flow rate and pressure achieved during manual ventilation and a much less controlled flow of gas is delivered into a patient's airway than in the case of a mechanical ventilator.
  • An object of the present invention is to provide an apparatus that improves the effectiveness of the breathing or ventilation, and/or intervenes in the case of inadequate breathing or ventilation, that obviates at least one of the disadvantages of the prior art.
  • Another object of the present invention is to synchronize mechanical ventilation and chest compressions during CPR.
  • Yet another object of the present invention is to facilitate expiration during ventilation.
  • a still further object of the present invention is to provide a control algorithm for breathing or ventilation.
  • the invention provides an apparatus for monitoring breathing or ventilation of a patient during resuscitation, comprising ventilation detecting means for detecting values of ventilation parameters such as an airway pressure level, airway flow, timing and/or an airway CO2 level and comprising processing means for determining an optimum treatment strategy based on the detected values, wherein the apparatus is arranged to compare the actual treatment provided by an operator with the optimum treatment strategy and to provide feedback to an operator with respect to the effect of the actual treatment.
  • ventilation detecting means for detecting values of ventilation parameters such as an airway pressure level, airway flow, timing and/or an airway CO2 level
  • processing means for determining an optimum treatment strategy based on the detected values
  • the processing means are arranged to process the detected values and/or to calculate certain predetermined control parameters.
  • the apparatus monitors different parameters including e.g. pressure, timing and flow in the airway during breathing or ventilation particularly during resuscitation.
  • the apparatus processes data of the detected values of the ventilation parameters, calculates control parameters, determines the optimum treatment strategy based on the detected values and/or the control parameters and gives feedback to the operator with respect to the effectiveness of the breathing or ventilation, and/or intervenes in the case of inadequate breathing or ventilation.
  • the apparatus determines an optimum treatment strategy and proposes the optimum treatment strategy to the operator. The operator performs actions and the apparatus gives feedback depending on the effect of the actions in relation to the optimum treatment strategy.
  • the processing means may give feedback to the drive means for automatically driving the apparatus to resuscitate the patient depending on a detected value of a ventilation parameter, and thus depending on the effectiveness of the breathing or ventilation.
  • the operator may focus more on the overall condition of the patient, e.g. on medication and/or injuries.
  • An automatic ventilation apparatus may be used in hospital care, home care as well as in emergency care situations.
  • the apparatus according to the invention may be provided with ventilation detecting means for detecting values of ventilation parameters, such as airway pressure level, airway CO2 level, oxygen saturation and/or respiratory flow. Also, the apparatus according to the invention may be provided with cardiac detecting means for detecting values of cardiac parameters, such as blood pressure, pulse or thoracic impedance. Other ventilation and/or cardiac parameters may also be detected.
  • the values of the ventilation parameters may be used to determine a relatively optimal ventilation for automatically resuscitating a patient, and/or may be given as information to e.g. an operator of the ventilation apparatus.
  • the values of the cardiac parameters may be used as information for e.g. an operator for giving for example chest compressions, either manually or automatically via an external device.
  • the values of the detected ventilation and/or cardiac parameters may be displayed to a user and/or a medical assistant.
  • instructions may be provided on the display means to a user and/or a medical assistant for the treatment of the patient.
  • a system comprising such an apparatus and further comprising a defibrillator, thus enabling a simultaneous treatment of the patient of the breathing or ventilation function and the heart function.
  • the defibrillator is an automatic defibrillator which may be coupled to the apparatus and thus may be provided with the detected values for cardiac parameters for automatically defibrillating a patient.
  • a system comprising such a ventilation apparatus and further comprising a chest fixation device, wherein the processing means of the apparatus are arranged for processing detected values of cardiac parameters and ventilation parameters for providing internal chest compression via automatic resuscitating of the patient.
  • patient breathing or ventilation is synchronized with patient chest compression.
  • a chest fixation device e.g. a chest band arranged around the chest of a patient
  • the volume of the chest of the patient is approximately fixated.
  • the lungs of the patient may be expanded and contracted regularly. Due to the chest fixation, the outer volume of the chest may not expand more and thus the expanding lungs are pressing against the heart, resulting in internal chest compression, thereby providing a heart massage.
  • the effect of such an internal chest compression may approximately be similar to an external chest compression, e.g. provided manually or via an automatically contracting chest belt.
  • an operator and/or a medical assistant can focus more on the condition of the patient, such as medication or injuries.
  • the ventilation apparatus may be coupled to the patient via a masque or via a tube in the airway.
  • the apparatus according to the present invention is provided with means for monitoring breathing or ventilation of a patient, having for example an airway pressure and/or an airway CO2 level monitor that signals the occurrence of low CO2 levels during expiration.
  • the apparatus of the invention is provided with various means for detecting and/or collecting data, in particular pressure data and CO2 data, and provided with microprocessors for storing and processing said data.
  • the apparatus of the invention is further provided with means for displaying and/or signalling information. Signalling may e.g. take place by giving an alarm to the user, by suggesting an action to be taken to the user, or by sending a control signal to a control device to take controlling action.
  • the apparatus of the invention is interfaced with a defibrillator, such as an AED and/or a CPR device provided with a load distributing band for delivering mechanical chest compressions (Auto CPR).
  • a defibrillator such as an AED and/or a CPR device provided with a load distributing band for delivering mechanical chest compressions (Auto CPR).
  • the apparatus may be provided with means for detecting and/or collecting data regarding the pressure and/or flow in the patient's airway.
  • a relatively high airway pressure at a relatively low flow during inspiration is a measure for the presence of obstructions in the airway, whereas a relatively low pressure at a relatively high flow indicates the presence of leaks.
  • Certain control parameters may be calculated from airway pressure and flow according to known formulas, which are also e.g. used by mechanical ventilators including e.g.
  • Typical control parameters include the expiration volume during 1 second (FEVi), the breathing volume from maximum expiration to maximum inspiration, also known as inspirational vital capacity (IVC), and the ratio between FEVi and IVC, which is known as Tiffeneau index.
  • FEVi expiration volume during 1 second
  • IVC inspirational vital capacity
  • Tiffeneau index is ⁇ 70% is a strong indication of a restrictive obstruction in the airway or reduced elasticity of the lung (alveoli), which is typical for patients suffering from Chronic Obstructive Pulmonary Disease (COPD).
  • COPD Chronic Obstructive Pulmonary Disease
  • the apparatus may be provided with means for detecting and/or collecting data regarding the CO2 concentration level in the patient's airway. A change in the maximum CO2 concentration level during expiration is a measure for the perfusion.
  • the apparatus may be provided with means for detecting and/or collecting data regarding respiratory flow in the airway.
  • the apparatus may be provided with means for detecting and/or collecting data regarding oxygen saturation including the pulsation pattern thereof in the patient.
  • Oxygen saturation is a measure for the effectiveness of breathing or ventilation.
  • the oxygen saturation level during a CPR procedure particularly the saturation measured with a sensor placed on the ear or the forehead, which measures oxygen saturation in the primary circulation, may be used as an additional control signal for the defibrillator.
  • a normal or pace-able heart rhythm requires a minimum oxygen saturation level in order to be maintained or in order to resume after an electric shock. Once that minimum level is detected, compressions must stop and pacing may start. Ventilation is continued using a ventilation mask or tube.
  • the cardiac output may be derived, which is a direct measure for the effectiveness of chest compressions.
  • the apparatus may further be provided with a means for detecting and/or collecting data regarding the electric activity of the heart and thus the heart function, such as a set of electrodes normally used by the defibrillator to measure an electrocardiogram ("ECG").
  • ECG electrocardiogram
  • the system is arranged to synchronise the patient ventilation with the chest compressions such that simultaneous with the chest compression also the patient is automatically ventilated.
  • the system comprises processing means that is arranged to determine an optimal treatment for both ventilation and chest compression depending on the parameters detected and/or control parameters calculated. So an optimum treatment of the patient may be obtained.
  • the invention also provides for a defibrillator device, comprising cardiac detecting means for detecting values of cardiac parameters, further comprising ventilation detection means for detecting values of ventilation parameters, such as an airway pressure level and/or an airway CO2 level, further comprising processing means for processing detected values of the detected cardiac and ventilation parameters, wherein the defibrillator device is arranged to signal the detected values of the cardiac parameters and ventilation parameters.
  • the defibrillator device may also give information and/or instructions about the breathing or ventilation of the patient.
  • the defibrillator device may control an automatic ventilation apparatus.
  • An automatic ventilation apparatus may also be combined with a CPR or with pacing of the heart for heart massage or heart frequency adjustment respectively.
  • an AED can also be used to provide feedback and instructions on pulmonary resuscitation.
  • such an AED is arranged to monitor respiratory flow. This way, the respiratory minute volume of the patient can be monitored and compared with a target.
  • the invention also provides for a defibrillator device that is arranged to monitor oxygen saturation level and pulsation measured with a saturation sensor e.g. placed on the ear or the forehead and to derive blood pressure information there from. This way, feedback may be provided on the ventilation effectiveness or the patient's respiratory movement to the patient and/or the operator.
  • a saturation sensor e.g. placed on the ear or the forehead
  • a valve apparatus comprising a valve housing with an inspiration chamber and an evacuation chamber, wherein the valve housing comprises a combined fresh gas inlet with a gas evacuation outlet, wherein the fresh gas inlet comprises a valve which is open in a first position to allow fresh gas to flow to the inspiration chamber and to close off the evacuation chamber during inspiration and which is closed in a second position to close off the fresh gas inlet for coupling the inspiration chamber to the evacuation outlet during expiration for creating a negative pressure in the valve apparatus during expiration.
  • the evacuation chamber may be closed off from the inspiration chamber during inspiration.
  • the inspiration chamber may be coupled to the evacuation chamber and thus to the evacuation outlet.
  • the inspiration chamber empties and a negative pressure may be created in the valve housing during expiration.
  • the airway of the patient is provided with a negative pressure during expiration, which may help the expiration of the patient, thus providing an active expiration to the patient.
  • active expiration is particularly advantageous for COPD patient since it facilitates a faster and deeper expiration of the patient, which under normal circumstances may be very difficult. For example in home care situations, when the patient has difficulties with expiration, active expiration may facilitate the expiration of the patient.
  • active expiration is provided in combination with a control mechanism to prevent a negative end pressure.
  • a control mechanism to prevent a negative end pressure.
  • An advantage of active expiration during CPR is that the reduced pressure in the airway or thoracic cavity of the patient may facilitate a quick expiration of the gas volume which was introduced into the patient with limited pressure during compression, resulting in a slightly reduced pressure at the end of the expiration providing an additional force for blood to flow from the venous system into the lung.
  • active expiration is combined with a saturation sensor placed on the ear or the forehead as described above of a defibrillator device.
  • the valve housing may be built up again during inspiration.
  • a fresh gas inlet which is coaxially combined with the gas evacuation outlet, a compact connection may be provided for fresh gas and evacuation gas, thus reducing the number of connection cables.
  • valve apparatus may be provided with various sensors for detecting and/or measuring ventilation parameters.
  • the values of these parameters may further be processed by processing means and may be signalled to the operator to give information and/or feedback to the operator.
  • the values may be provided to a control unit for controlling drive means for automatically driving the ventilation apparatus.
  • valve apparatus may be a Pmax valve apparatus, i.e. a valve apparatus with a maximum pressure level.
  • the valve apparatus may be an adjustable valve apparatus, i.e. a valve apparatus of which the pressure level may be varied.
  • different embodiments of a valve apparatus that is arranged to provide a negative expiration pressure at the beginning of an expiration may be possible. Further advantageous embodiments are given in the dependent claims.
  • Fig. 1 shows a control apparatus according to the present invention in a typical manual CPR setup.
  • Fig. 2 shows a apparatus according to the present invention in a typical mechanical CPR setup.
  • Fig. 3 shows a typical set of curves for sensed pressure, CO2, impedance and pulsation.
  • Fig. 4 shows an algorithm for controlled manual CPR to be used in the control apparatus according to the present invention.
  • Fig. 5 shows an algorithm for controlled mechanical CPR to be used in the control apparatus according to the present invention.
  • Fig. 6 shows a valve apparatus according to the invention during inspiration (Fig. 6a) and expiration (Fig. 6b).
  • a typical manual CPR setup comprises a face mask 1, which is provided with a pressure transducer 11 that is connected to the control apparatus 2, which in turn is connected to an Automatic External Defibrillator AED 3.
  • the face mask may be used with a resuscitation bag 4 as shown in Fig. 1.
  • a resuscitation bellows may be used, which provides a constant volume of air when fully squeezed.
  • the face mask is provided with straps that may be fitted around the head of the patient, such that the face mask may be secured airtight over the nose and mouth of the patient.
  • the pressure transducer measures the pressure in the airway passage from the resuscitator to the patient.
  • the face mask is further provided with a CO2 sensor 12, which may comprise, for example, an infrared source and a detector. Other forms of CO2 detection may be substituted as well.
  • This sensor may be provided in the passage from the resuscitator to the airway of the patient, in which case the CO2 level is measured and displayed without delay.
  • the senor may be provided in a separate sensor unit connected to the passage through a relatively long sampling line that samples a small stream of gas to the sensor unit, in which case the CO2 level is measured and displayed with a known delay, which is related to the length and diameter of the sampling line.
  • the control apparatus 2 is further provided with a pulsation sensor 13, which may be attached to the forehead of a patient using a headband. Alternatively the pulsation sensor 13 may be clamped to the earlobe or nose of the patient.
  • the control apparatus 2 is provided with processing means for processing values detected by the sensors of various parameters.
  • the processing means are arranged to determine an optimum treatment strategy and to propose the optimum treatment strategy to the operator of the system.
  • the optimum treatment strategy may be proposed via display means, e.g. a screen on the AED 3.
  • the processing means may also calculate certain predetermined control parameters, e.g. FEVi or IVC.
  • the optimum treatment strategy may be determined based on the detected values of the sensed parameters and/or on the calculated control parameters.
  • the apparatus is further arranged to compare the optimum treatment strategy with the actions performed by the operator and to provide feedback to the operator with respect to the effect of his/her actions.
  • the apparatus may e.g. display the feedback, but it may also be possible to provide voice instructions to the operator.
  • the detected values and/or the calculated control parameters may be signalled to the operator, e.g. visual in a display or audio via a voice instruction.
  • the setup of fig.1 may be used by a lay person with training skills in Basic Life Support (BLS).
  • BLS Basic Life Support
  • the single adaptation to the BLS procedure is to place the face mask over nose and mouth of the patient, to fit the straps around the head of the patient and to attach the pulsation sensor.
  • the AED gives instructions and/or information to the user concerning the CPR.
  • the AED may also give information and/or instructions to the user concerning the ventilation of the patient depending on the detected values of the pressure sensor 11 and/or the CO2 sensor 12.
  • a typical mechanical CPR setup comprises a face mask 1 provided with pressure sensor 11 and CO2 sensor 12 that is connected to the control apparatus 2 in a similar way as explained in fig.l.
  • the face mask 1 may be used with a flow generator 5, which is also connected to the control apparatus 2. Furthermore a load distributing band 6 is connected to the control apparatus 2 for providing mechanical chest compressions.
  • the setup of fig. 2 may be used for example by paramedics of the emergency medical services.
  • the two adaptations to the Advanced Life Support procedure are: 1) to place the face mask over nose and mouth of the patient, to fit the straps and attach the pulsation sensor, and 2) to attach the load distributing band to the patient.
  • the control apparatus 2 then synchronizes inspiration and chest compression in a ratio of 1:1.
  • control unit 2 controls the flow generator 5 for providing the patient with fresh air via the mask 11.
  • the flow generator 5 may be the drive means that drive the ventilation apparatus for resuscitating the patient controlled automatically by the control unit 2.
  • the control unit 2 may also control the defibrillator device for automatically providing compressions to the patient's chest.
  • the patient may be provided with a chest band 6 that may contract, whereby the contractions are controlled by the control unit, depending on values detected of cardiac parameters, such as pulse determined by the pulsation sensor 13.
  • a fixed chest band may be provided avoiding the volume of the chest to be expanded. Due to e.g. automatic ventilation, the lungs of the patient may be expanded and contracted. Expansion of the chest may not be possible because of the fixed chest band thereby giving an internal chest compression and a pressing of the lungs against the heart, resulting in a heart massage that is synchronous with the ventilation of the patient.
  • an automatic ventilation apparatus is used in combination with a fixed chest band, an operator may focus more on other aspects of the condition of the patients, e.g. medication or injuries. Heart massage and ventilation of the patient are thus provided simultaneously.
  • the control apparatus 2 may have a wireless connection (not shown) with an emergency department of a hospital, for transmitting data thereto and for receiving feedback from emergency medicine physicians based there. Also, the ventilation apparatus of Fig. 1 may be driven automatically be a flow generator and controlled automatically by the control unit, similar to the embodiment of Fig. 2.
  • a typical output of the various sensors during pulmonary resuscitation using a CPR setup as displayed in Fig. 1 comprises an airway pressure curve 1, a ventilation flow curve 2, a CO2 curve 3 and a pulsation- saturation curve 4. Inspiration and expiration are clearly distinguished phases in the airway pressure curve 1, also showing the maximum pressure exerted on the airway during inspiration and the residual pressure that is retained in the airway and lungs of the patient after expiration. This situation, where a residual pressure keeps the alveoli open and prolongs the exchange of gases, helps to improve oxygen saturation and is referred to as positive end expiration pressure or PEEP. Maximum pressure and PEEP are important control parameters during pulmonary resuscitation, particularly in the case of near- drowning.
  • a typical control algorithm for manual CPR comprises the steps of:
  • - a control loop for recognising and treating leaks; - a control loop for recognising and treating airway obstructions; - sensing an airway CO2 level and plotting a CO2 curve;
  • the pressure curve plotted from recorded pressure data displays the inspiration pressure and PEEP level achieved during ventilation and by comparing the achieved levels with standard settings, the control apparatus determines deviations e.g. too low or too high pressure levels, which may be due to obstructions, such as vomit or blood clots, or leakage, and signals these deviations to the operator. Subsequently, the control apparatus instructs the operator to take specific actions to treat the probable causes of these deviations and restore normal ventilation.
  • the CO2 curve plotted from recorded CO2 data displays the CO2 level achieved during inspiration and expiration and by comparing the achieved levels with standard settings, the control apparatus may signal the operator in case the achieved values deviate from the standard, in particular too low concentration levels, which may be due to inadequate lung perfusion or insufflations of the stomach. Subsequently the control apparatus instructs the operator to take specific actions such as the instruction to insert a tube into the patient's throat to treat the probable causes of these deviations and restore normal perfusion.
  • the pulsation and oxygen saturation curve plotted from recorded pulsation and saturation data displays the venous pressure level achieved and the oxygen saturation level achieved, and by comparing the achieved levels with standard settings, the control apparatus may signal the operator in case the achieved values deviate from the standard, which may be due to ineffective compression of the patient's chest. Subsequently the control apparatus instructs the operator to take specific actions to treat the probable causes of these deviations.
  • the thoracic impedance curve plotted from recorded thoracic impedance data displays the variation in the thoracic cavity and thus the volume of the lungs and by comparing the achieved levels with standard settings, the control apparatus may signal the operator in case the achieved values deviate from the standard, which may be due to ineffective ventilation. Subsequently the control apparatus instructs the operator to take specific actions to treat the probable causes of these deviations.
  • a typical control algorithm for mechanical CPR comprises similar steps as referred to in Fig. 4, with an additional step in that the thoracic impedance is compared with the pulsation curve.
  • the control loop for recognising and treating ineffective ventilation is replaced by a control loop for synchronizing ventilation with chest compressions.
  • control apparatus By providing the control apparatus with such extended control algorithms containing the recognized and approved best practices of emergency medicine physicians and professional respiratory therapists, the situation is achieved that these best practices are embedded in the hardware and are thus available to all users of that hardware.
  • Fig. 6 shows a valve apparatus 100 according to the invention.
  • the valve apparatus 100 comprises a valve housing 110 with an inspiration chamber 101 and an evacuation chamber 102.
  • a fresh gas flow inlet (FGF) 103 is connected to the inspiration chamber 101.
  • An evacuation outlet 104 is connected to the evacuation chamber 102.
  • the fresh gas flow inlet 103 and the evacuation outlet 104 are combined coaxially, to provide an efficient and elegant connection of the valve apparatus 100 to an evacuation line (not shown) and a fresh gas line (not shown).
  • the fresh gas flow inlet 103 is provided with a valve 105, which is in this embodiment provided as a duckbill valve. However, other types of valves may also be provided.
  • the valve 105 is open and provides for an open connection between the fresh gas flow inlet 103 and the inspiration chamber 102 to a patient connection 106.
  • the evacuation chamber 102 is cut off from the inspiration 'route' via the valve 105.
  • fresh gas is supplied under pressure to the patient.
  • the pressure during inspiration is approximately 20 hPa or more in the valve housing to enable a good inspiration by the patient.
  • the valve 105 is closed and the fresh gas flow inlet 103 is closed off from the valve apparatus 100.
  • the inspiration chamber 101 is in fluid communication with the evacuation chamber 102 and the evacuation outlet 104. Air in the inspiration chamber 101 will flow to the evacuation outlet 104. During expiration a negative pressure may be in the valve housing 110, thereby facilitating expiration of the patient.
  • the valve apparatus may also be combined with a maximum pressure valve and/or with an adjustable pressure valve, and/or in other valve apparatus applications.
  • sensors may be provided to measure and/or detect values of ventilation parameters, such as airway pressure and/or CO2 content and/or oxygen saturation.
  • the detected values of the ventilation parameters may be provided as information to an operator or as input to an automatic ventilation apparatus.

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Abstract

L'invention concerne un appareil de surveillance de la respiration et de la ventilation d'un patient pendant la réanimation, qui signale la présence de bas niveaux de CO2 pendant l'expiration du patient. L'appareil est doté d'un détecteur de pression des voies respiratoires et d'un détecteur de niveau de CO2 dans les voies respiratoires. L'appareil peut en outre être doté d'un détecteur de pulsations et de saturation et d'un détecteur de débit respiratoire. L'invention concerne également un procédé de surveillance de la respiration et de la ventilation d'un patient dans lequel l'apparition de bas niveaux de CO2 pendant l'expiration est signalée et un procédé de synchronisation de la ventilation et des compressions du torse.
PCT/NL2009/050700 2008-11-19 2009-11-19 Appareil et système de surveillance de la respiration et de la ventilation, dispositif de défibrillation, appareil et système de surveillance des compressions du torse et appareil à valves Ceased WO2010059049A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL2002225A NL2002225C2 (en) 2008-11-19 2008-11-19 Apparatus and system for monitoring breathing or ventilation, defibrillator device, apparatus and system for monitoring chest compressions, valve apparatus.
NL2002225 2008-11-19

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WO2010059049A2 true WO2010059049A2 (fr) 2010-05-27
WO2010059049A3 WO2010059049A3 (fr) 2010-07-08

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US11654234B2 (en) 2014-11-04 2023-05-23 Respiratory Motion, Inc. Respiratory parameter guided automated IV administration and IV tube clamp activation
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