WO2010059049A2 - Apparatus and system for monitoring breathing or ventilation, defibrillator device, apparatus and system for monitoring chest compressions, valve apparatus - Google Patents

Apparatus and system for monitoring breathing or ventilation, defibrillator device, apparatus and system for monitoring chest compressions, valve apparatus 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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WIPO (PCT)
Prior art keywords
apparatus
ventilation
apparatus according
valve
further
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PCT/NL2009/050700
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French (fr)
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WO2010059049A3 (en
Inventor
Gerardus Wilhelmus Lugtigheid
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Emergency Pulmonary Care B.V.
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Priority to NL2002225A priority Critical patent/NL2002225C2/en
Priority to NL2002225 priority
Application filed by Emergency Pulmonary Care B.V. filed Critical Emergency Pulmonary Care B.V.
Publication of WO2010059049A2 publication Critical patent/WO2010059049A2/en
Publication of WO2010059049A3 publication Critical patent/WO2010059049A3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M16/0009Accessories therefor, e.g. sensors, vibrators, negative pressure with sub-atmospheric pressure, e.g. during expiration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H31/00Artificial respiration or heart stimulation
    • A61H31/004Heart stimulation
    • A61H31/005Heart stimulation with feedback for the user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022Control means therefor
    • A61M16/024Control means therefor including calculation means, e.g. using a processor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/208Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3925Monitoring; Protecting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H2230/00Measuring physical parameters of the user
    • A61H2230/04Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H2230/00Measuring physical parameters of the user
    • A61H2230/20Blood composition characteristics
    • A61H2230/207Blood composition characteristics partial O2-value
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H2230/00Measuring physical parameters of the user
    • A61H2230/30Blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL 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
    • A61H2230/00Measuring physical parameters of the user
    • A61H2230/40Respiratory characteristics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/201Controlled valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/04Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/205Blood composition characteristics partial oxygen pressure (P-O2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/30Blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/40Respiratory characteristics
    • A61M2230/43Composition of exhalation
    • A61M2230/432Composition of exhalation partial CO2 pressure (P-CO2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/65Impedance, e.g. conductivity, capacity

Abstract

An apparatus (2) for monitoring breathing or ventilation of a patient during resuscitation, that signals the occurrence of low CO2 levels during expiration of the patient. The apparatus (2) is provided with an airway pressure sensor (11) and an airway C02 level sensor (12). The apparatus (2) can further be provided with a pulsation (13) and saturation sensor and a respiratory flow sensor.

Description

Title: Apparatus and system for monitoring breathing or ventilation, defibrillator device, apparatus and system for monitoring chest compressions, valve apparatus.

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.

Furthermore, 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".

During a CPR procedure a defibrillator, in particular an AED, provides unambiguous feedback and instructions. Existing ventilation equipment however, 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. As a result 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. Thus there is a need for improved control during pulmonary resuscitation.

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. To that effect 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.

Preferably, the processing means are arranged to process the detected values and/or to calculate certain predetermined control parameters. By providing ventilation detection means, the apparatus monitors different parameters including e.g. pressure, timing and flow in the airway during breathing or ventilation particularly during resuscitation. By providing processing means 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. For example, during a complex situation, the operator is assisted by the apparatus to provide an optimum treatment to the patient. By providing drive means for automatically driving the apparatus, 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. By providing an automatic ventilation apparatus, 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.

By providing display means the values of the detected ventilation and/or cardiac parameters may be displayed to a user and/or a medical assistant. Also, instructions may be provided on the display means to a user and/or a medical assistant for the treatment of the patient. In an aspect of the invention, a system is provided 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. Advantageously, 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.

In another aspect of the invention, a system is provided 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.

Preferably, patient breathing or ventilation is synchronized with patient chest compression. By providing 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. By providing automatic resuscitation of the patient, 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. However, by providing an internal chest compression, 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.

Preferably 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. Preferably 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). 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. the Evita 4XL from Draeger and the Maquet Servo1 (NAVA), which is electromyogram controlled. 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. A 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).

In addition 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. In addition the apparatus may be provided with means for detecting and/or collecting data regarding respiratory flow in the airway. Furthermore 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.

From the pulsation pattern, 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"). Advantageously, 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. Preferably, 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.

Further means for detecting and/or collecting data and/or parameters other than previously mentioned may be provided as the operator may think fit.

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. By providing a defibrillator device that also may detect ventilation parameters, the defibrillator device may also give information and/or instructions about the breathing or ventilation of the patient. In an advantageous embodiment, 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.

In an embodiment, by signalling the occurrence of low CO2 levels during expiration, an AED can also be used to provide feedback and instructions on pulmonary resuscitation. Preferably, 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.

According to an aspect of the invention which is particularly advantageous for both CPR and COPD patients, a valve apparatus is provided 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.

By providing a valve in the fresh gas inlet, the evacuation chamber may be closed off from the inspiration chamber during inspiration. Also, by providing the valve in the fresh gas inlet, the inspiration chamber may be coupled to the evacuation chamber and thus to the evacuation outlet. By coupling the inspiration chamber to the evacuation outlet, the inspiration chamber empties and a negative pressure may be created in the valve housing during expiration. Thus 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. Such 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. Preferably, active expiration is provided in combination with 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. In a very advantageous embodiment such active expiration is combined with a saturation sensor placed on the ear or the forehead as described above of a defibrillator device.

Preferably, during inspiration there is an excess pressure of approximately 20 hPa or more in the valve housing and thus on the patient. Preferably, during expiration, in particular at the beginning of the expiration, there is a negative pressure of approximately 10 hPa or less in the valve housing and thus on the patient, to facilitate expiration of the patient. At the end of the expiration, the pressure is approximately zero. The pressure in the valve housing may be built up again during inspiration. By providing 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.

In an embodiment, the 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. Also, the values may be provided to a control unit for controlling drive means for automatically driving the ventilation apparatus.

In an embodiment the valve apparatus may be a Pmax valve apparatus, i.e. a valve apparatus with a maximum pressure level. In an other embodiment, the valve apparatus may be an adjustable valve apparatus, i.e. a valve apparatus of which the pressure level may be varied. Also, 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.

The invention will be further explained using graphs and examples of preferred embodiments. 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).

Referring to Fig. 1, 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. Alternatively a resuscitation bellows may be used, which provides a constant volume of air when fully squeezed. Preferably 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. It provides a measure of the actual pressure achieved in the airway of the patient during breathing or pulmonary resuscitation. 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.

Alternatively the sensor 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. In addition, 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). 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. Referring to Fig. 2, 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.

Depending on the collected data of the ventilation parameters, the 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. Thereto, 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. Alternatively, 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. When 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.

Referring to Fig. 3, 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. Referring to Fig. 4, a typical control algorithm for manual CPR comprises the steps of:

- sensing an airway pressure and a ventilation flow and plotting a pressure and flow curve;

- 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;

- a control loop for recognising and treating low perfusion;

- sensing oxygen saturation and pulsation and plotting a saturation and pulsation curve; - a control loop for recognising and treating ineffective compression

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.

Referring to Fig. 5, 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.

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. In this embodiment, 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. During inspiration, as shown in Fig. 6a, 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. During inspiration, fresh gas is supplied under pressure to the patient. Preferably the pressure during inspiration is approximately 20 hPa or more in the valve housing to enable a good inspiration by the patient. During expiration, the valve 105 is closed and the fresh gas flow inlet 103 is closed off from the valve apparatus 100. Due to the closed valve 105, 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. Also, in the valve housing, 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.

The invention is not limited to the preferred embodiments described herein. Within the context of the invention many variations are possible.

Claims

Claims
1. 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 for determining an optimum treatment strategy based on the detected values, wherein the apparatus is arranged to compare the actual actions performed by an operator with the optimum treatment strategy and to provide feedback to the operator with respect to the effect of the actual actions.
2. The apparatus according to claim 1, wherein the processing means further are arranged for processing detected values.
3. The apparatus according to claim 1 or 2, wherein the processing means further are arranged for calculating certain control parameters.
4. The apparatus according to any one of the preceding claims, further comprising drive means for automatically driving the apparatus to resuscitate the patient depending on a detected value of a ventilation parameter and/or a control parameter.
5. The apparatus according to any one of the preceding claims, wherein the apparatus signals the occurrence of low CO2 levels during expiration of the patient.
6. The apparatus according to any one of the preceding claims, wherein the ventilation detecting means comprise a pressure sensor for detecting an airway pressure level and/or a CO2 sensor for detecting an airway CO2 level.
7. The apparatus according to any one of the preceding claims, wherein the ventilation detecting means further comprise a pulsation and/or oxygen saturation sensor.
8. The apparatus according to any one of the preceding claims, wherein the ventilation detection is arranged to monitor respiratory flow.
9. The apparatus according to any one of the preceding claims, further being provided with a respiratory flow monitor.
10. The apparatus according to any one of the preceding claims, further comprising display means for displaying detected values of ventilation parameters.
11. The apparatus according to any one of the preceding claims, further comprising cardiac detecting means for detecting values of heart parameters, such as pulse or blood pressure, wherein the processing means further are arranged for processing the detected values of heart parameters.
12. The apparatus of claim 11, wherein the display means further are arranged to signal a low blood pressure.
13. The apparatus of claim 11 or 12, wherein the cardiac detecting means are further arranged to monitor cardiac output from an ECG signal and wherein the display means further are arranged to signal the occurrence of low cardiac output.
14. The apparatus according to any one of the claims 11 - 13, wherein the cardiac detecting means further are arranged for detecting pulsation and/or thoracic impedance.
15. The apparatus according to any one of the claims 11 - 14, wherein the display means further are arranged for displaying detected values of cardiac parameters.
16. A system comprising the apparatus of claims 1-15 and further comprising a defibrillator.
17. A system of claim 16, wherein the defibrillator is an automatic external defibrillator.
18. A system comprising the automatic ventilation apparatus according to any of the claims 11 — 15, further comprising a chest fixation device and wherein the processing means of the apparatus are arranged for processing detected values of cardiac parameters and ventilation parameters for providing chest compression via automatic resuscitating of the patient.
19. The system of claim 18, wherein the processing means of the apparatus further are arranged to synchronize patient ventilation with patient chest compressions.
20. The system of claim 18 or 19, wherein the chest fixation device comprises a chest band.
21. A defibrillator device, comprising cardiac detecting means for detecting values of cardiac parameters, further comprising ventilation detecting 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 and/or the ventilation parameters.
22. The defibrillator device of claim 21, wherein the defibrillator device is arranged to control a ventilation apparatus according to any one of the claims 1 - 9.
23. The defibrillator device of claim 21 or 22, arranged to monitor oxygen saturation level and to derive a blood pressure level there from.
24. A defibrillator device according to any one of the claims 21 - 23, arranged to monitor thoracic impedance.
25. The defibrillator device of any of the claims 21 - 24, wherein the defibrillator is an automatic external defibrillator.
26. 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 an 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.
27. Valve apparatus according to claim 26, wherein the fresh gas inlet and the gas evacuation outlet are coaxially integrated.
28. Valve apparatus according to claim 26 or 27, wherein the valve apparatus further comprises a patient connection.
29. Valve apparatus according to any one of the claims 26 - 28, wherein the valve apparatus comprises a manometer.
30. Valve apparatus according to any one of the claims 26 - 29, wherein the valve apparatus is a Pmax valve apparatus and/or an adjustable pressure valve apparatus.
31. Valve apparatus according to any one of the claims 26 - 30, wherein the valve is a duckbill valve.
32. Valve apparatus according to any one of the claims 26 - 31, wherein the valve apparatus is integrated in the head of a ventilation balloon.
33. Method for providing a negative pressure in a valve apparatus during expiration, wherein an expiration chamber and an evacuation chamber are coupled to a gas evacuation outlet during expiration.
34. System according to any of the claims 16 - 20, further comprising a valve apparatus according to any of the claims 26 - 32.
PCT/NL2009/050700 2008-11-19 2009-11-19 Apparatus and system for monitoring breathing or ventilation, defibrillator device, apparatus and system for monitoring chest compressions, valve apparatus WO2010059049A2 (en)

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