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WO2011021978A1 - Contrôle coordonné d'un dispositif de ventilation et d'un dispositif d'assistance pulmonaire - Google Patents

Contrôle coordonné d'un dispositif de ventilation et d'un dispositif d'assistance pulmonaire Download PDF

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Publication number
WO2011021978A1
WO2011021978A1 PCT/SE2010/050891 SE2010050891W WO2011021978A1 WO 2011021978 A1 WO2011021978 A1 WO 2011021978A1 SE 2010050891 W SE2010050891 W SE 2010050891W WO 2011021978 A1 WO2011021978 A1 WO 2011021978A1
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WIPO (PCT)
Prior art keywords
subject
control unit
blood
ventilator
assist device
Prior art date
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Ceased
Application number
PCT/SE2010/050891
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English (en)
Inventor
Christer Ahlmén
Mario Loncar
Mats Wallin
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Maquet Critical Care AB
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Maquet Critical Care AB
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Publication of WO2011021978A1 publication Critical patent/WO2011021978A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • A61M1/3667—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines with assisted venous return
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0042—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the expiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • A61M2016/1025—Measuring a parameter of the content of the delivered gas the O2 concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • A61M2016/103—Measuring a parameter of the content of the delivered gas the CO2 concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3561—Range local, e.g. within room or hospital
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • 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)
    • 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
    • A61M2230/435—Composition of exhalation partial O2 pressure (P-O2)

Definitions

  • the present invention relates to a control unit according to the preamble of claim 1 , a ventilatory support system according to the preamble of claim 8, a lung assist device according to the preamble of claim 9, a ventilator according to the preamble of claim 10, a ventilatory support monitoring system according to the preamble of claim 11, a method according to the preamble of claim 12, and a computer program according to the preamble of claim 15.
  • Ventilators and heart-lung machines are well known types of medical equipment that are used to provide ventilatory and sometimes circulatory support to patients with reduced lung capacity. Ventilators are primarily used to provide ventilatory support to patients with decreased ventilation due to different medical conditions.
  • the ventilator
  • a treatment allowing carbon dioxide to be removed from, and oxygen to be added to, the circulatory system of a patient through gas exchange within the lungs, provided by a ventilator through the supply of breathing gases to the pulmonary system of the patient, will herein be referred to as a respiratory treatment.
  • Heart-lung machines are primarily used to provide ventilatory (and circulatory) support to patients having reduced lung and/or heart capacity in situations where less-invasive conventional treatments, such as mechanical ventilation, are insufficient.
  • a heart-lung machine mimics the function of the heart and lungs.
  • Carbon dioxide rich blood is pumped from the patient to an oxygenator which serves as an artificial lung by removing carbon dioxide and adding oxygen to the blood before the oxygen-enriched blood is returned to the circulatory system of the patient.
  • a treatment allowing carbon dioxide to be removed from the circulatory system of a patient through oxygenation of a machine-generated flow of blood, provided by a heart-lung machine or any machine capable of doing so, will herein be referred to as an extracorporeal lung assist treatment (ECLA).
  • ECLA extracorporeal lung assist treatment
  • ECMO extracorporeal membrane oxygenation
  • ECO2R extracorporeal carbon dioxide removal
  • a control unit for controlling the operation of either or both of a first and second apparatus of which one is a ventilator for providing a respiratory treatment to a subject by supplying a breathing gas to the lungs of the subject, and the other is a lung assist device for providing an extracorporeal lung assist (ECLA) treatment to the subject by generating a flow of blood from the subject, oxygenating the blood, and returning the oxygen-enriched blood to the subject.
  • the control unit is characterised in that it is configured to generate a control signal controlling the operation of the second apparatus in response to a control parameter obtained by the first apparatus.
  • a ventilatory support system comprising a first and a second apparatus of which one is a ventilator configured to provide a respiratory treatment to the subject, and the other is a lung assist device configured to provide an ECLA treatment to a subject.
  • the system further comprises a control unit configured to generate a control signal controlling the operation of the second apparatus in response to a control parameter obtained by the first apparatus.
  • the object is also achieved by a method for controlling the operation of either or both of the first and second apparatus (i.e. either or both of the ventilator and the lung assist device) when connected to a subject.
  • the method is characterized by the step of controlling the operation of the second apparatus based on a control parameter obtained by the first apparatus.
  • the method is typically performed by a control unit in a ventilator, a control unit in a lung assist device, or a control unit in a ventilatory support monitoring system connected to one or both of the ventilator and the lung assist device.
  • the control unit is caused to perform the method by a computer program running on a processing means, such as a microprocessor, in the control unit.
  • the control unit further comprises a computer readable medium, for example a non- volatile memory in form of a read-only memory, a flash memory, a hard disk drive or the like, which computer readable medium stores the computer program in form of computer readable code.
  • a computer program for controlling the operation of either or both of the first and second apparatus which computer program comprises computer readable code causing a control unit to perform the above-mentioned method when executed by a processing means in the control unit.
  • the invention also provides a computer program product comprising a computer readable medium, for example a non- volatile memory in form of a readonly memory, a flash memory, a hard disk drive, a CD ROM or the like, which computer readable medium stores the above described computer program in form of computer readable code.
  • a control parameter obtained by an apparatus is a parameter that is indicative of anything that affects or is affected by the treatment provided by that apparatus. It may be a setting parameter related to the current settings of the apparatus, a sensor parameter indicative of measurements obtained by sensors of the apparatus, or a calculated parameter calculated based on measurements obtained by the sensors of the apparatus.
  • the second apparatus By controlling the operation of the second apparatus based on a control parameter obtained by the first apparatus, the second apparatus can be controlled based on the treatment and/or the effect of the treatment currently provided by the first apparatus.
  • the means and method of the invention allow the respiratory treatment and the ECLA treatment to be coordinated such that an effective and non-injurious overall treatment can be provided to a patient who is connected to both a ventilator and a lung assist device.
  • the present invention thus provides a new type of ventilatory support system wherein a ventilator and a lung assist device are made to cooperate to provide a patient with the best possible ventilatory support.
  • control signal is generated in response to a control parameter indicative of the degree of removal Of CO 2 from the subject's circulatory system, achieved by the currently provided ECLA and respiratory treatments, and the operation of the second apparatus is controlled such that the degree of CO 2 removal from the subject's circulatory system, achieved by the treatment provided by the second apparatus, is adjusted in response to the control parameter.
  • control unit can generate a control signal which intensifies the ECLA treatment provided by the lung assist device so as to increase the amount of CO 2 removed from the circulatory system of the patient by the ECLA treatment and hence the total amount of CO 2 removed by the two treatments.
  • the control unit operates the lung assist device to accomplish the required CO 2 reduction.
  • the ventilation can be maintained at a healthy intensity, minimizing the risk of injuring the pulmonary system of the patient, while the CO 2 content in the circulatory system of the subject can be maintained at an acceptable level.
  • a "healthy ventilation intensity” is herein considered to be a ventilation intensity wherein the tidal volume of breathing gas supplied to the patient does not exceed 6 ml/kg predicted bodyweight, and wherein the peak pressure delivered to the patient does not exceed 30 mbar.
  • control unit may automatically control the operation of the ventilator based on the control parameter so as to increase the amount of CO 2 that is removed from the circulatory system of the patient by the respiratory treatment.
  • one of the apparatuses can be operated to compensate for any occasional or permanent insufficiency in CO 2 removal achieved by the treatment provided by the other apparatus such that no apparatus has to be operated at an intensity level which may jeopardize the safety of the patient.
  • the intensities of the respiratory treatment and the ECLA treatment can be automatically adjusted to provide effective but yet lenient ventilatory support to the patient.
  • Another advantage with the proposed ventilatory support system is that since the ventilator assists the lung assist device in the removal Of CO 2 out of the patient's circulatory system, the flow through the lung assist device can be reduces as compared to the required flow through a lung assist device (such as a conventional heart-lung machine) being the sole device providing ventilatory support to the patient. While a conventional heart-lung machine typically operates at flows between 4 and 7 litres per minute, it has been found that flows of 0,5-1,5 1/min or even less may be sufficient to maintain the CO 2 content in the circulatory system of a patient at an acceptable level when the lung assist device is used in parallel with a ventilator operating at an healthy ventilation intensity, even when treating patients suffering from severe lung diseases.
  • the cannulae and tubes connecting the lung assist device with the circulatory system of the patient can be made much thinner than normally required. This fact makes the connection of a patient to the lung assist device less critical since the use of thinner cannulae and tubes reduces the risk of bleedings and eliminates the requirement of specialized vascular surgeons to carry out the procedure.
  • a conventional heart-lung machine normally is connected between a large vein (e.g. the inferior or superior vena cava) and a large artery (e.g. the aorta)
  • the proposed lung assist device which only requires a fraction of the blood flow normally required may be connected to the patient through a vein-to-vein connection having a common or two separate connection points.
  • the lung assist device may be connected to the patient through a vein-to-vein connection by means of a double lumen cannula, similar to cannulae commonly used in dialysis.
  • control parameter obtained by a ventilator which can be used to control the operation of a lung assist device is a sensor parameter indicative of the CO 2 content in the gases expired by the patient, which content may be measured by a conventional gas analyzer located in or connected to the Y-piece of the ventilator.
  • the control parameter obtained by the ventilator and used for controlling the lung assist device is indicative of the end tidal CO 2 (EtCO 2 ) concentration in the gases expired by the patient.
  • the EtCO 2 concentration is closely related to the partial pressure of carbon dioxide (PaCO 2 ) in the arterial blood and is hence a good measure of whether the combined effect of the currently provided respiratory and ECLA treatments is sufficient to maintain the CO 2 content in the patients circulatory system at an acceptable level.
  • an operator can set the intensity of the ventilation to a desired, fix level, e.g. by setting the ventilator to deliver a tidal volume of 6 ml/kg predicted bodyweight to the patient, whereupon the lung assist device can be automatically controlled based on EtCO 2 measurements obtained by the ventilator so as to help the ventilator in the ventilatory support of the patient in case the respiratory treatment turns out to be insufficient to maintain the EtCO 2 concentration at an acceptable level.
  • An example of a control parameter obtained by a lung assist device which can be used to control the operation of a ventilator is a sensor parameter indicative of the saturation level of oxygen (SaO 2 ) in the haemoglobin of the flow of blood that is withdrawn from the patient.
  • This level may be measured e.g. by a blood gas analyzer, an online saturation analyzer, or the like, located upstream or downstream of an oxygenator in the lung assist device.
  • the control signal that is generated by the control unit in response to the control parameter may control the apparatus in question in any appropriate manner.
  • control unit when the control unit controls the operation of the ventilator based on control parameters obtained by the lung assist device, the control unit may be configured to generate control signals controlling the flow of breathing gas supplied to the patient and/or the composition of the breathing gas supplied to the patient. This may be achieved e.g. by configuring the control unit such that it regulates one or several valves in a gas mixing and flow generating unit of the ventilator in response to the control parameters.
  • control unit When the control unit controls the operation of the lung assist device based on control parameter obtained by the ventilator, the control unit may be configured to generate control signals controlling the flow of said generated flow of blood, and/or the flow and/or concentration of oxygen supplied to the generated flow of blood. This may be achieved e.g. by configuring the control unit such that it regulates an electric current provided to an electric pump serving as flow generating means of the lung assist device and/or regulates one or several valves in an oxygenator within the lung assist device.
  • the control unit according to the invention may be located in any of the first or second apparatus (i.e. any of the lung assist device or the ventilator) or any other device that is communicatively connected at least to the apparatus that is to be controlled based on control parameters obtained by the other apparatus, for example a ventilatory support monitoring system for monitoring and/or controlling the operation of the lung assist device and/or the ventilator.
  • a ventilatory support monitoring system for monitoring and/or controlling the operation of the lung assist device and/or the ventilator.
  • a single control unit is adapted to control the operation of the lung assist device based on control parameters obtained by the ventilator, and to control the operation of the ventilator based on control parameters obtained by the lung assist device.
  • a control unit can be located in the lung assist device and adapted to receive control parameters from, and transmit control signals to, the ventilator via a control connection in form of a wired or wireless connection communicatively connecting the lung assist device and the ventilator.
  • the ventilator and the lung assist device in the proposed ventilatory support system comprise a respective control unit which is configured to exchange control parameters with the control unit of the other apparatus via the control connection.
  • the control unit of the lung assist device can be made to control the operation of the lung assist device based on control parameters received from the ventilator whereas the control unit of the ventilator can be made to control the operation of the ventilator based on control parameters received from the lung assist device.
  • the second apparatus or a ventilatory support monitoring system controlling the operation of the second apparatus may comprise a user input device, such as a keypad, and the control unit, located in the second apparatus or the ventilatory support monitoring system, may be configured to receive the control parameter from the user input device.
  • the first apparatus, or the ventilatory support monitoring system if connected to the first apparatus may comprise a display device, such as a digital display screen, which is configured to display control parameters obtained by the first apparatus.
  • FIG. 1 illustrates a ventilatory support system according to one embodiment of the invention
  • Fig. 2 illustrates a ventilatory support system according to another embodiment of the invention
  • Fig. 3 illustrates a ventilatory support system according to yet another embodiment of the invention
  • Fig. 4 illustrates a control unit according to one embodiment of the invention.
  • Fig. 1 illustrates a ventilatory support system 1 comprising a lung assist device 3 and a ventilator 4, both connected to the same patient 7.
  • the lung assist device 3 and the ventilator 4 are both examples of ventilatory support devices used to provide ventilatory support to patients with reduced lung capacity.
  • the lung assist device 3 is configured to provide extracorporeal lung assist (ECLA) treatment to the patient 7 by generating a flow of blood from the patient, oxygenating the blood, and returning the oxygen-enriched blood to the patient.
  • the step of oxygenating the blood is performed by accomplishing a gas exchange through which the carbon dioxide in the blood is replaced by oxygen.
  • oxygenation of blood should herein be interpreted as a process including both the step of removing carbon dioxide (CO 2 ) from the blood, and the step of adding oxygen (O 2 ) to the blood.
  • the lung assist device 3 comprises flow generating means 9, typically in form of one or several roller, turbine and/or centrifugal pumps.
  • the flow generating means 9 generates a flow of blood through tubing forming a blood flow path 11 of the lung assist device, in which the blood flows in a clockwise direction as indicated by arrows in the drawing.
  • Oxygenation of the blood is performed by means of an oxygenating means 13, typically in form of a bubble oxygenator or a membrane oxygenator arranged downstream of the flow generating means 9.
  • the oxygenating means 13 is connected to an inlet 15 of the lung assist device 3 through which it receives a flow of oxygen from an oxygen supply (not shown).
  • the oxygenating means 13 then removes carbon dioxide from and adds oxygen to the blood by, in a controllable way, discharging oxygen into the blood.
  • the lung assist device 3 may further comprise one or several blood reservoirs (not shown) in which the gas exchange takes place. Furthermore, the lung assist device 3 comprises a sensor arrangement 17, 19, 21 for obtaining sensor measurements related to the ongoing ECLA treatment of the patient 7, such as the composition of the blood before and/or after removal of carbon dioxide, the pressure and/or flow in the blood flow path 11, upstream and/or downstream of the flow generating means 9, etc.
  • the sensor arrangement comprises a first flow/pressure sensor 17 for measuring the flow and/or pressure in the blood flow path 11, upstream of the flow generating means 9, a blood gas analyzer 19 for measuring the O 2 and/or CO 2 content of the blood in the blood flow path 11, upstream or downstream of the oxygenating means 13, and a second flow/pressure sensor 21 for measuring the flow and/or pressure in the blood flow path 11, downstream of the oxygenating means 13.
  • the lung assist device 3 may comprise a so called online saturation analyzer (not shown) which determines the O 2 saturation of the blood by optical analysis (basically by determining the colour of the blood).
  • Such an online saturation analyzer may be arranged upstream or downstream of the oxygenating means 13 along the blood flow path 11, or connected to the tubing transporting blood from or to the patient 7.
  • Other components typically included in a heart-lung machine, such as heat exchangers and temperature sensors, may be arranged along the gas flow path 11 of the lung assist device 3 but have been omitted in the drawing so as not to obscure the drawing with unnecessary detail.
  • the sensors 17, 19, 21, the flow generating means 9, and the oxygenating means 13 are electrically connected to a control unit 5 A which may be configured to automatically control the flow generating means 9 and/or the oxygenating means 13 based on the sensor parameters measured by the various sensors 17, 19, 21.
  • the control unit 5 A is also connected to a user input device 23 A, such as a keypad, pressure display or rotary control knob, and configured to control the flow generating means 9 and/or the oxygenating means 13 based on user input parameters that are input on the user input device 23 A by an operator 25.
  • the control unit 5A is connected to a display device 27A, such as a digital display screen or a pressure display, and configured to display various lung assist device-related parameters informing the operator 25 about the ongoing ECLA treatment.
  • a lung assist device-related parameter may be setting parameter indicative of a current lung assist device setting chosen by the operator 25 via the user input device 23 A, a sensor parameter measured by any of the sensors 17, 19, 21 of the lung assist device 3, and/or a calculated parameter calculated by the control unit 5 A of the lung assist device 3 based on the sensor measurements.
  • any such lung assist device-related parameter carrying information of an ongoing ECLA treatment may be used to control the operation of the ventilator 4 and will hereinafter, when used for this purpose, be referred to as a lung assist device-related control parameter.
  • the ventilator 4 is configured to provide respiratory treatment to the patient 7 by supplying a breathing gas to the lungs of the subject.
  • the ventilator 4 comprises a gas mixing and flow generating means 23 which is connected to a plurality of inlets 26A-C of the ventilator 4 through which it may receive various gases, such as air, oxygen and heliox from one or several gas supplies (not shown).
  • the gas mixing and flow generating means 23 mixes the gases from the gas supplies and delivers a suitable breathing gas composition to the patient 7 via an inspiratory line 28, a Y-piece 29, a common line 31 and a patient connector (not shown), such as a breathing mask or tracheal tube.
  • the ventilator 4 further comprises an expiratory line 33 for conveying gases expired by the patient back to the ventilator 4 and out through an outlet 35, typically connected to a scavenging system (not shown).
  • the ventilator 4 comprises a sensor arrangement 37, 39, 41 for obtaining sensor measurements related to the ongoing respiratory treatment of the patient 7, such as the composition of the breathing gases supplied to the patient 7 and/or the gases expired by the patient 7, the inspiratory and expiratory pressure and/or flow, etc.
  • the sensor arrangement comprises a first pressure/flow sensor 37 disposed in the inspiratory line 28 for measuring the inspiratory pressure and flow, a gas analyzer 39 disposed in the common line of the Y-piece 29 for measuring the O 2 and CO 2 content of the breathing gases and the exhalation gases, and a second flow/pressure sensor 31 disposed in the expiratory line 33 for measuring the expiratory pressure and flow.
  • the sensors 37, 39, 41 and the gas mixing and flow generating means 23 are electrically connected to a control unit 5B which may be configured to automatically control the gas mixing and flow generating means 23 based on the sensor parameters measured by the various sensors 37, 39, 41.
  • the control unit 5 B is also connected to a user input device 23B, such as a keypad, pressure display or rotary control knob, and configured to control the gas mixing and flow generating means 23 based on user input parameters that are input on the user input device 23B by the operator 25.
  • the control unit 5B is connected to a display device 27B, such as a digital display screen or pressure display, and configured to display various ventilator-related parameters informing the operator 25 about the ongoing respiratory treatment.
  • a ventilator-related parameter may be a setting parameter indicative of a current ventilator setting chosen by the operator 25 via the user input device 23B, a sensor parameter measured by any of the sensors 37, 39, 41 of the ventilator 4, and/or a calculated parameter calculated by the control unit 5B of the ventilator 4 based on the sensor measurements.
  • any such ventilator-related parameter related to an ongoing respiratory treatment may be used to control the operation of the lung assist device 3 and will hereinafter, when used for this purpose, be referred to as a ventilator-related control parameter.
  • Fig. 1 illustrates a ventilatory support system 1 configured for automatic, coordinated control of a ventilator 4 and a lung assist device 3.
  • the ventilatory support system 1 comprises two control units 5 A, 5B of which at least one is configured to receive a control parameter obtained by one of the apparatuses 3, 4 and generate a control signal controlling the operation of the other apparatus 4, 3 in response thereto.
  • the lung assist device 3 and the ventilator 4 is communicatively connected to each other through a wired or wireless connection 43, hereinafter referred to as a control connection.
  • the control unit 5 A of the lung assist device 3 and the control unit 5B of the ventilator 4 are arranged to exchange control parameters over the control connection 43.
  • the control unit 5B of the ventilator 4 is configured to transmit ventilator-related control parameters to the control unit 5 A of the lung assist device 3, which control parameters, as previously mentioned, may comprise any parameters related to the ongoing respiratory treatment provided by the ventilator 4, such as setting parameters indicative of current ventilator settings, sensor parameters measured by sensors 37, 39, 41 of the ventilator 4, and/or calculated parameters calculated by the control unit 5B of the ventilator 4 based on measurements obtained by the sensors 37, 39, 41.
  • the control unit 5 A of the lung assist device 3 is in turn configured to receive the ventilator-related control parameters and generate a control signal controlling the operation of the lung assist device 3 in response thereto.
  • control unit 5 A of the lung assist device 3 is configured to transmit lung assist device-related control parameters to the control unit 5B of the ventilator 4, which control parameters, as previously mentioned, may comprise any parameters related to the ongoing ECLA treatment provided by the lung assist device 3, such as setting parameters indicative of current lung assist device settings, sensor parameters measured by sensor 17, 19, 21 of the lung assist device 3, and/or calculated parameters calculated by the control unit 5 A of the lung assist device 3 based on measurements obtained by the sensors 17, 19, 21.
  • the control unit 5B of the ventilator 4 is in turn configured to receive the lung assist device-related control parameters and generate a control signal controlling the operation of the ventilator 4 in response thereto.
  • the ventilator-related control parameters transmitted from the ventilator 4 to the lung assist device 3 are indicative of the end tidal CO 2 (EtCO 2 ) concentration in the gases expired by the patient. If the ventilator-related control parameters indicate that the EtCO 2 concentration is high, the control unit 5 A of the lung assist device 3 increases the intensity of the ECLA treatment by increasing the blood flow rate through the blood flow path 11 and/or increasing the flow of oxygen supplied to the blood by the oxygenator 13.
  • the control unit 5 A may be configured to increase the blood flow by increasing the electric current supplied to an electric motor driving the flow generating means 9, and to increase the flow of oxygen supplied to the blood by regulating a valve in the oxygenating means 13.
  • ventilator-related control parameters which may be used to control the operation of the lung assist device 3 are sensor parameters, setting parameters and/or calculated parameters indicative of the level of absorption of oxygen by the patient's lungs.
  • sensor measurements of the flow and oxygen content of the breathing gases supplied to the patient 7 together with sensor measurements of the flow and oxygen content of the gases expired by the patient 7 can be used by the ventilator 4 to obtain a calculated parameter indicating the patient's capability of absorbing oxygen from the breathing gas, which calculated parameter in turn can be used as a ventilator-related control parameter.
  • the flow of breathing gases supplied to the patient 7 may be measured by the pressure/flow sensor 37 in the inspiratory line 28 of the ventilator 4, while the flow of gases expired by the patient may be measured by the pressure/flow sensor 41 in the expiratory line 33.
  • the oxygen content in the breathing gases and the oxygen content in the exhalation gases may both be measured by the gas analyzer 39 positioned in the common line of a Y-piece 29, which gas analyzer can be used to obtain measurements during both inspiration and expiration.
  • suitable ventilator-related control parameters for controlling the lung assist device 3 are setting parameters, sensor parameters or calculated parameters indicative of the intensity level of the currently provided respiratory treatment, such as parameters indicative of the flow rate of the supplied breathing gas, the tidal volume delivered to the patient 7, the peak airway pressure of the patient 7, the breathing gas
  • the lung assist device-related control parameters transmitted from the lung assist device 3 to the ventilator 4 are preferably indicative of the oxygen saturation (SaO 2 ) in the blood that is withdrawn from the patient 7 and has not yet been oxygenated, measured by the blood gas analyzer 19 or an online saturation analyzer as mentioned above.
  • the degree of oxygen saturation in the blood that is already oxygenated by the lung assist device 3 may also be used as a lung assist device- related control parameter. If the lung assist device-related control parameters indicate that the SaO 2 level is low, the control unit 5B of the ventilator 4 increases the intensity of the respiratory treatment by increasing the flow and/or the oxygen content of the breathing gases supplied to the patient 7.
  • the control unit 5B may be configured to increase the flow of breathing gases supplied to the patient 7 by regulating an inspiratory valve in the ventilator 4, and to increase the oxygen content in the breathing gases by regulating a valve of the gas mixing and flow generating means 23.
  • the saturation of peripheral oxygen (SpO 2 ) and the partial pressure of oxygen (PaO 2 ) are examples of other parameters which may be measured by sensors in the lung assist device and used as control parameters for controlling the ventilator.
  • control parameters that may be obtained by the lung assist device 3 and used to control the operation of the ventilator 4 are sensor parameters, setting parameters, or calculated parameters indicative of the intensity level of the currently provided ECLA treatment, such as parameters indicative of the flow rate of the generated flow of blood and/or the flow rate of the flow of oxygen supplied to the blood by the oxygenating means 13 of the lung assist device 3.
  • the control units 5A, 5B may be adapted to adjust the intensities of the ECLA and respiratory treatments for each received control parameter but is typically adapted to compare the control parameter with a predetermined threshold value and to adjust the intensity of the respective treatment only when the control parameter exceeds the threshold value.
  • control units 5 A, 5B are adapted to adjust the intensity of the respective treatments only when each of a plurality of consecutively received control parameters exceeds the predetermined threshold value.
  • control units 5 A, 5B may be adapted to establish a trend for a plurality of consecutively received control parameters and to adjust the intensity of the respective treatments based on the trend. For example, if the control unit 5 A of the lung assist device establishes a trend for the received ventilator-related control parameters indicating an increasing EtCO 2 concentration in the gases expired by the patient 7 over time, it may be adapted to increase the intensity of the ECLA treatment although none of the individually received control parameters exceeds a threshold value representing a critical EtCO 2 concentration level.
  • Fig. 2 a ventilatory support system 10 according to another embodiment of the invention is shown.
  • the ventilatory support system 10 comprises a ventilatory support monitoring system 6 (hereinafter referred to as simply the monitoring system) for monitoring and/or controlling any or both of the lung assist device 3 and the ventilator 4.
  • the monitoring system 6 is connected to the lung assist device 3 via a first wired or wireless control connection 43A and to the ventilator 4 via a second wired or wireless control connection 43B.
  • the control unit 5 C of the monitoring system 6 is adapted to receive lung assist device-related control parameters via the first control connection 43 A, generate control signals controlling the operation of the ventilator 4 in response to the lung assist device-related control parameters, and transmit the control signals to the ventilator 4 via the second control connection 43B.
  • the control unit 5C of the monitoring system 6 is also adapted to receive ventilator-related control parameters via the second control connection 43B, generate control signals controlling the operation of the lung assist device 3 in response to the ventilator-related control parameters, and transmit these control signals to the lung assist device 3 via the first control connection 43B.
  • the lung assist device 3 and the ventilator 4 comprise a respective sub-control unit 45 A, 45B which are configured to communicate with the control unit 5C of the monitoring system 6.
  • Each of the sub-control units 45A, 45B is adapted to obtain control parameters related to the apparatus 3, 4 to which it belongs, and transmit them to the control unit 5 C of the monitoring system 6.
  • Each of the sub-control units 45 A, 45B is also adapted to receive control signals from the control unit 5C of the monitoring system 6 and control the operation of the apparatus 3, 4 to which it belongs in accordance therewith.
  • the monitoring system 6 is further seen to comprise a user input device 23 C, such as a keypad, pressure display or rotary control knob, and a display device 27C, such as a digital display screen or a pressure display.
  • the control unit 5 C is adapted to display, on the display device 27C, the lung assist device-related control parameters and the ventilator-related control parameters received from the lung assist device 3 and the ventilator 4, respectively.
  • the sub-control units 45 A, 45B of the lung assist device 3 and the ventilator 4 may be exchanged for the control units 5A, 5B previously described with reference to Fig.
  • the monitoring system 6 may be adapted to simply forward the lung assist device-related control parameters received from the lung assist device 3 to the control unit 5B of the ventilator, and the ventilator-related control parameters received from the ventilator 4 to the control unit 5 A of the lung assist device 3.
  • Such an arrangement may still be advantageous compared to the arrangement in Fig. 1 in that both the ECLA treatment and the respiratory treatment can be monitored by the operator 25 via the display unit 27C of the monitoring system 6, and/or manually controlled by the operator 25 via the user input device 23 C of the monitoring system 6.
  • a ventilatory support system 100 according to yet another embodiment of the invention is shown. This embodiment of the ventilatory support system 100 differs from the
  • Figs. 1 and 2 in that the lung assist device 3 and the ventilator 4 are not communicatively connected to each other, and in that the coordinated control of the ventilator 4 and the lung assist device 3 is based on user input.
  • the lung assist device 3 and the ventilator 4 comprise a respective user input device 23 A, 23B and a respective display device 27A, 27B, which user input devices 23 A, 23B and display devices 27A, 27B, in a way previously described with reference to Fig. 1, are adapted to communicate with the respective control unit 5 A, 5B of the lung assist device 3 and the ventilator 4.
  • the control unit 5 A of the lung assist device 3 is hence adapted to display lung assist device-related control parameters on the display device 27A
  • the control unit 5B of the ventilator 4 is adapted to display ventilator-related parameters on the display device 27B.
  • the user input device 23 A, 23B of the first apparatus 3, 4 is adapted to allow the operator 25 to input thereon a control parameter obtained by the second apparatus 4, 3, whereupon the control unit 5 A, 5B of the first apparatus 3, 4 is adapted to receive the input control parameter from the user input device 23 A, 23B and to generate a control signal controlling the operation of the first apparatus 3, 4 in response thereto.
  • the control parameter obtained by the second apparatus 4, 3 may hence be displayed to the operator 25 on the display device 23B, 23 A of the second apparatus and used to control the first apparatus 23 A, 23B by manually inputting the control parameter on the user input device 23 A, 23B of the first apparatus 3, 4.
  • the user input device 23 A of the lung assist device 3 may be adapted to allow the operator 25 to input a ventilator-related control parameter thereon, whereupon the control unit 5 A of the lung assist device 3 generates a control signal controlling the operation of the lung assist device 3 in response thereto so as to adjusts the intensity of the currently provided ECLA.
  • the user input device 23B of the ventilator 4 may be adapted to allow the operator 25 to input a lung assist device-related control parameter thereon, whereupon the control unit 5B of the ventilator generates a control signal controlling the operation of the ventilator 4 in response thereto so as to adjusts the intensity of the currently provided respiratory treatment.
  • the feature of allowing an operator 25 to control any of the apparatuses 3, 4 by manually inputting a control parameter obtained by the other apparatus 4, 3 on a user input device 23 A, 23B may be combined with the automatic coordinated control of the lung assist device 3 and the ventilator 4 previously described with reference to Figs. 1 and 2.
  • the user input devices 23 A, 23B, 23C of the lung assist device 3, the ventilator 4, and/or the monitoring system 6 in Figs. 1 and 2 may be adapted to allow the operator 25 to manually input control parameters related to any one of the apparatuses 3, 4, whereupon a control signal controlling the operation of the other apparatus 4, 3 can be generated in response thereto.
  • control unit 5B of the ventilator 4 may be configured to determine one or several recommended lung assist device settings based on one or several ventilator- related control parameters and to communicate the recommended lung assist device setting(s) to the operator 25, e.g. by displaying the recommendations on the display device 27B.
  • the control unit 5B of the ventilator may be configured to display a recommendation telling the operator 25 to increase the intensity of the ECLA treatment provided by the lung assist device.
  • the control unit 5 A of the lung assist device 3 may be configured to, in a corresponding manner, determine and communicate recommended ventilator settings based on lung assist device-related parameters.
  • the present invention also relates to a method for controlling the operation of either or both of a first and second apparatus connected to a subject 7, of which one apparatus is a ventilator 4 for providing a respiratory treatment to the subject 7 by supplying a breathing gas to the subject's lungs, and the other apparatus is a lung assist device 3 for providing an ECLA treatment to the subject 7 by generating a flow of blood from the subject, oxygenating the blood, and returning the oxygen-enriched blood to the subject.
  • the method is characterized in that the operation of the second apparatus is controlled based on a control parameter obtained by the first apparatus.
  • the operation of the lung assist device may be controlled based on a control parameter obtained by the ventilator and/or the operation of the ventilator may be controlled based on a control parameter obtained by the lung assist device.
  • the method may be performed by a control unit 5B in the ventilator 4, a control unit 5 A in the lung assist device 3, a control unit 5C in a ventilatory support monitoring system 6, or by two or more of these control units 5A, 5B, 5C working together to perform the method.
  • any control unit 5A, 5B, 5C fully or partially performing the method is caused to do so by a computer program running on a processing means of the control unit.
  • the control unit 5 may hence be any of the control units 5 A, 5B or 5C in Figs. 1, 2 and 3.
  • the control unit 5 comprises a computer readable medium 47, for example a non-volatile memory in form of a read- only memory, a flash memory, a hard disk drive or the like, which computer readable medium stores a computer program 49 in form of computer readable code.
  • the control unit 5 further comprises a processing means 51 , such as a microprocessor. When the computer program 49 is executed by the processing means 51 , the computer program causes the control unit 5 to fully or partially perform the above- mentioned method of controlling the operation of the lung assist device 3 based on a control parameter obtained by the ventilator 4, or vice versa.

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Abstract

La présente invention concerne une unité de contrôle (5A-C) qui contrôle le fonctionnement d'un premier et/ou d'un deuxième appareil (3, 4) dont l'un est un ventilateur (4) qui délivre un traitement respiratoire à un sujet (7) en délivrant un gaz respiratoire aux poumons du sujet, l'autre étant un dispositif (3) d'assistance pulmonaire qui assure un traitement extracorporel d'assistance pulmonaire [ECLA] au sujet (7) en produisant un écoulement de sang depuis le sujet, en oxygénant le sang et en renvoyant au sujet le sang enrichi en oxygène. L'unité de contrôle est configurée pour délivrer un signal de commande qui commande le fonctionnement du deuxième appareil en réponse à un paramètre de commande obtenu par le premier appareil. Par conséquent, l'unité de commande permet de coordonner le traitement respiratoire et le traitement ECLA de manière à assurer au patient une assistance ventilatoire efficace mais modérée.
PCT/SE2010/050891 2009-08-21 2010-08-17 Contrôle coordonné d'un dispositif de ventilation et d'un dispositif d'assistance pulmonaire Ceased WO2011021978A1 (fr)

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