WO2009115944A1 - Procédé et système pour commander automatiquement une variable physiologique d'un patient en boucle fermée - Google Patents

Procédé et système pour commander automatiquement une variable physiologique d'un patient en boucle fermée Download PDF

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Publication number
WO2009115944A1
WO2009115944A1 PCT/IB2009/051011 IB2009051011W WO2009115944A1 WO 2009115944 A1 WO2009115944 A1 WO 2009115944A1 IB 2009051011 W IB2009051011 W IB 2009051011W WO 2009115944 A1 WO2009115944 A1 WO 2009115944A1
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WO
WIPO (PCT)
Prior art keywords
patient
user
physiological variable
additional information
controlling
Prior art date
Application number
PCT/IB2009/051011
Other languages
English (en)
Inventor
Gerhard Tivig
Rolf Neumann
Guenter Gegner
Harald Greiner
Original Assignee
Philips Intellectual Property & Standards Gmbh
Koninklijke Philips Electronics N.V.
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Application filed by Philips Intellectual Property & Standards Gmbh, Koninklijke Philips Electronics N.V. filed Critical Philips Intellectual Property & Standards Gmbh
Publication of WO2009115944A1 publication Critical patent/WO2009115944A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/412—Detecting or monitoring sepsis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/20—ICT specially adapted for the handling or processing of medical references relating to practices or guidelines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • 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
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/208—Blood composition characteristics pH-value
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • the invention relates to the field of automatically controlling a physiological variable of a patient, especially in a closed loop system.
  • a method for automatically controlling a physiological variable of a patient in a closed loop system comprising the following steps: automatically measuring a value for the physiological variable of the patient, and automatically treating the patient in order to affect the physiological variable based on a control algorithm using the measured value of the physiological variable, wherein input of additional information by a user is automatically requested, and wherein the additional information is used in the control algorithm for controlling the actuator.
  • physiological variable refers to a specific variable describing the patient's condition with respect to a specific physiological state, i.e. the patient's blood hemoglobin saturation
  • value or value for the physiological variable refers to a specific measure or indicator which is characteristic for the "physiological variable” and, thus, can also be an indirect measure, i.e. the varying part of the absorption spectrum of a pulse oximeter measurement in case of blood hemoglobin saturation.
  • the controlling procedure is continuously documented in a log file.
  • a log file can in general be at least partly done by paper.
  • the log file is exclusively electronic.
  • the log file preferably comprises at least one of: user inputs, measured values, and occurrence of predefined conditions.
  • the log file is preferably not only accessible after the treatment but already during the controlling procedure.
  • the additional information which is requested to be input by the user comprises at least one of: a currently not available measurement value, a non-measureable value, and a treatment confirmation. This way, the control algorithm can be provided with such additional information which is hardly accessible via automatic measurements and which can highly enhance the automatic controlling process.
  • input of additional information by a user is automatically requested periodically.
  • a protocol engine is run on a patient monitoring platform that allows clinicians to run clinical protocols that can monitor developments in the patient's condition. This application notifies the clinicians when certain conditions or combinations of conditions occur and it documents developments in a log which can be stored for further inspections.
  • a protocol engine is incorporated into a patient monitor allowing clinicians to run multiple clinical protocols simultaneously.
  • all protocol specifics are collected into configuration settings files. It is further, preferred that these settings are localized and therefore are language and country specific.
  • the settings information e.g. all kind of definitions of states and their transitions, parameter and thresholds, advisories and prompts, timing, configuration switches, can be loaded into the monitor.
  • This architecture allows to react on protocol definitions changes being able to perform protocol updates in an easy way without updating software to new versions.
  • protocol updates are carried out in the field by a customer support organization.
  • This architecture further allows for implementing different control loop levels, e.g. closed loop, supervised closed loop or open loop, or protocol variations of such a closed loop system to adapt to the current situation of the patient and the data currently available.
  • a closed loop system for automatically controlling a physiological variable of a patient, with a measuring unit for measuring a value for the physiological variable of the patient, an actuator for treating the patient in order to affect the physiological variable, a controller which is fed with the value for the physiological variable of the patient and for controlling the actuator based on a control algorithm using the measured value of the physiological variable, a protocol engine device running at least one protocol and for notifying a user and a user interface for indicating user notifications and for manually inputting additional information, wherein the protocol engine device is adapted for automatically requesting input of additional information via the user interface, the additional information being used in the control algorithm for controlling the actuator.
  • Preferred embodiments of the closed loop system according to the invention result from the preferred embodiments of the method according to the invention as described above.
  • the protocol engine device is adapted for documenting the controlling procedure in a log file. Further, it is especially preferred that multiple measuring units are provided. Furthermore, according to a preferred embodiment of the invention, the user interface is adapted for visualizing information on the patient's conditions. Finally, it is preferred the user interface is adapted for indicating an alarm.
  • the invention is the realization of a closed loop controller using a protocol based implementation with preferably one or more of the following features:
  • Natural way to guide the user through the various steps of the treatment by providing an interactive way to incorporate user inputs, e.g. by manually entries for measurements that are currently not available, confirmations, additional inputs for values that cannot be measured.
  • the human interface for the care giver is enhanced by providing multiple outputs that are optimized for the current situation, e.g. alarms, reminders, advisories, therapeutic recommendations or changes in the visualization of relevant data. Based on the current situation of the patient and the data currently available, the user can choose from a list of protocol variations.
  • Protocol definition files and/or configuration files can be used instead of providing different software engines.
  • An electronic log keeps track of all user inputs, all manually entered data and of all transitions to specific states.
  • This protocol log can be reviewed during the patient treatment, can be printed for documentation purpose and is useful for audit trails on compliance to guidelines.
  • the log can be exported to a central monitoring unit for further compliance tracking.
  • control loops e.g. closed loop controls, supervised controls and open loop controls.
  • FiO2 control infusion pumps medication control, e.g. to control the blood pressure of a patient
  • control for depth of anaesthesia e.g. control of intravenous - aesthetic agents during non-volatile anaesthesia procedures
  • glycemic control e.g. control of intravenous - aesthetic agents during non-volatile anaesthesia procedures
  • This method and system will be used mainly for hospitalized patients, but there are also applications possible for mobile patients in the hospital environment, during transport or at home. Also devices could make use of this invention that are intended for healthy persons or even animals.
  • Fig. 1 schematically depicts a system for a closed loop control according to a preferred embodiment of the invention
  • Fig. 2 schematically depicts a system for a closed loop control according to another preferred embodiment of the invention.
  • Fig. 3 schematically depicts a system for monitoring and controlling a patient according to still another preferred embodiment of the invention.
  • an optimized implementation approach of a physiologic closed-loop controller using a protocol engine as illustrated in Fig. 1 is provided.
  • a further preferred embodiment is the implementation of a closed loop controller using a protocol engine inside a patient monitor as shown in Fig. 2.
  • the closed loop system for automatically controlling a physiological variable of a patient 1 comprises a measuring unit 2 for measuring a value of the physiological variable of the patient 1, an actuator 3 for treating the patient in order to affect the physiological variable, and a controller 4 which is fed with the value for the physiological variable of the patient and for controlling the actuator 3 based on a control algorithm using the measured value of the physiological variable.
  • a protocol engine device 5 is provided which is running at least one protocol and which is further adapted for notifying a user. For such user notifications and for manually inputting additional information, a user interface 6 is provided.
  • controller 4, protocol engine device 5, and user interface 6 are implemented in a patient monitor 7 according to a further preferred embodiment of the invention.
  • the protocol engine device 5 is adapted for automatically requesting input of additional information via the user interface 6.
  • This additional information is used in the control algorithm for controlling the actuator 3 as set out in detail in the following.
  • the protocol engine device is incorporated in patient monitor which allows clinicians to run multiple clinical protocols simultaneously. All protocol specifics are collected in configuration settings files. These settings are localized and therefore language and country specific.
  • the settings information i.e. all kind of definitions of states and their transitions, parameters and thresholds, advisories and prompts, timing, configuration switches are loaded into the patient monitor 7.
  • different control loop levels e.g. closed loop, supervised closed loop or open loop, or protocol variations of such a closed loop system to adapt to the current situation of the patient and the data currently available can be achieved.
  • the protocol engine device 5, and the user interface 6 into patient monitor 7 is defined as a device/system that combines a protocol engine with at least the following functions:
  • Measure at least one physiological signal Measure at least one physiological signal, and Alarming capabilities for at least one measured signal and/or at least one interfaced physiological signal.
  • a patient monitor may comprise one or more of the following features:
  • a wired or wireless connected medical system solution e.g. a central station, a hospital information system, an electronic medical record.
  • Such a system allows reacting on multiple inputs and producing multiple outputs.
  • the protocol summarizes all decision nodes, actions, rules and states: Decision nodes: Evaluate logical combinations of input variables.
  • Actions Execute a specific action, e.g. change the screen.
  • Rules Connect the nodes with the actions.
  • any parameter combination e.g. one or more SpO2 measurements, transcutaneous measurement, skin color, blood gases, etc. can be combined to act as input variables for decision node interpretation.
  • the list of output actions includes the issuing of alerts, reminders and advisories, or switching to an application specific screen containing application specific graphical presentations like horizon trends, histogram view, events review or starting some application specific timers. Escalating notification levels can be implemented using graded severity alerts and advisories. Thus, this way, executing a clinical protocol in the patient monitor is allowed. It is an advantage of the preferred embodiment of the invention described above that the user can select from a list of several possible protocols, e.g.
  • closed loop control sepsis, ventilation weaning or ARDS (acute respiratory distress syndrome support, etc.) those which shall run simultaneously in the monitor.
  • ARDS acute respiratory distress syndrome support, etc.
  • all user interactions as well as user notifications are integrated into the overall patient monitor user interface. The user does not have to deal with an additional device for closed loop control.
  • the protocol engine based closed loop controller acts "behind the scene".
  • a further advantage of the integrated protocol engine is the capability to visualize for orientation purposes in which phase a specific protocol is and to inform the user whether the protocol is currently active or not on the same patient centric user interface.
  • a system for monitoring and controlling a patient 1 which comprises a patient sensor 2 for capturing a patient signal.
  • the system further comprises a patient monitor 7 with an integrated closed loop controller 14 which is fed with the patient signal and which controls a patient treating device 15, in the present case a mechanical ventilator, for treating the patient 1, i.e. for providing the patient 1 with oxygen.
  • a user interface 6 is provided.
  • This user interface 6 is adapted indicating information, e.g. information on the patient 1, on a display 17.
  • the user interface 6 comprises an input device 18, like a keyboard or a touch screen which can be identical with the display 17, which allows a user to input data. Requests for such data input by the user can be indicated via the display 17.
  • a monitoring processer 19 for processing the patient signal and for outputting processed data to the user interface 6, and a control processer 20 for processing the patient signal and for outputting processed data to the closed loop controller 14, are provided.
  • the monitoring processer 19 and the control processer 20 are fed with the same patient signal in the same pre-processing state.
  • the system also comprises an alarming unit 21 which is fed with the patient signal and which is adapted for providing common alarm conditions for monitoring and controlling, e.g. via display 17.
  • FiO2 is controlled automatically, i.e. closed loop control is performed.
  • the display 17 is only used for indicating monitoring data and no external data input is requested. Due to intentionally induced changes in the FiO2 value and/or due to changes of the FiO2 value due to normal control activities, according changes in the captured SpO2 value are expected.
  • This feedback is continuously kept under surveillance, and based on this feedback, there are the following actions of the system:
  • the response does not match with the current model of the transfer functions, but the deviations are in a range that allows to automatically adjusting the model of the transfer functions accordingly.
  • the user might get a low priority warning in regards to the model changes so the user can verify what triggered the changes of the transfer function and might want to correct those.
  • the 02 uptake of the lung is reduced due to accumulation of secretion, but with a slightly increase FiO2 level this can be compensated.
  • the care giver could improve the situation by sucking the patient airways this would trigger a medium or low urgency notification to the user.
  • the response does not match with the current model of the transfer functions and the deviations are so extreme or do not fit into the model that an automatically adjustment of the model is not feasible or too risky.
  • the user is informed of this situation with a higher urgency.
  • the urgency level might also depend on the actual state of the patient variable, but in any case it is important the user is aware of the situation as it might be impossible for the closed loop system to properly react on potential degradation of the patient's conditions in the future. For example, due to airway obstruction there is nearly no air reaching the lungs so the SaO2 will drop quickly even when the FiO2 is set to the maximum. This is a change in the transfer function of the patient that cannot be compensated by the closed loop control system.
  • a high urgency notification is triggered to the user.
  • the 02 supply for the patient got disconnected and the patient is breathing room air.
  • this might cause only a slight drop of SaO2 that might still be in the acceptable range, but the closed loop controller has no control anymore to provide higher FiO2 levels if the patient might require it in the future.
  • This triggers a medium urgency notification to the user.
  • a change from closed loop to open loop is performed and input of external data from a user is requested.

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Abstract

L'invention concerne un système en boucle fermée permettant de commander automatiquement une variable physiologique d'un patient (1), et qui comporte une unité de mesure (2) pour mesurer une valeur de la variable physiologique du patient (1); un actionneur (3) pour traiter le patient (1) afin de modifier la variable physiologique; un organe de commande (4) auquel est appliquée la valeur de la variable physiologique du patient (1) et qui sert à commander l'actionneur (3) sur la base d'un algorithme de commande, au moyen de la valeur mesurée de la variable physiologique; un dispositif (5) de moteur de protocole (5) exécutant au moins un protocole et qui sert à notifier un utilisateur; et une interface utilisateur (6) pour indiquer les notifications d'utilisateur et introduire manuellement des données complémentaires. Le dispositif (5) de moteur de protocole est conçu pour demander automatiquement l'introduction de données complémentaires par l'intermédiaire de l'interface utilisateur (6), ces données complémentaires étant utilisées dans l'algorithme de commande pour commander l'actionneur (3). Ce système, qui permet de commander automatiquement une variable physiologique d'un patient (1) en boucle fermée, est fiable, facile à manier et particulièrement bien accepté par le personnel soignant.
PCT/IB2009/051011 2008-03-17 2009-03-11 Procédé et système pour commander automatiquement une variable physiologique d'un patient en boucle fermée WO2009115944A1 (fr)

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EP08102664.3 2008-03-17
EP08102664 2008-03-17

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Cited By (21)

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US8381729B2 (en) 2003-06-18 2013-02-26 Breathe Technologies, Inc. Methods and devices for minimally invasive respiratory support
US8955518B2 (en) 2003-06-18 2015-02-17 Breathe Technologies, Inc. Methods, systems and devices for improving ventilation in a lung area
US8418694B2 (en) 2003-08-11 2013-04-16 Breathe Technologies, Inc. Systems, methods and apparatus for respiratory support of a patient
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US8136527B2 (en) 2003-08-18 2012-03-20 Breathe Technologies, Inc. Method and device for non-invasive ventilation with nasal interface
US8925545B2 (en) 2004-02-04 2015-01-06 Breathe Technologies, Inc. Methods and devices for treating sleep apnea
US8985099B2 (en) 2006-05-18 2015-03-24 Breathe Technologies, Inc. Tracheostoma spacer, tracheotomy method, and device for inserting a tracheostoma spacer
US10058668B2 (en) 2007-05-18 2018-08-28 Breathe Technologies, Inc. Methods and devices for sensing respiration and providing ventilation therapy
US8567399B2 (en) 2007-09-26 2013-10-29 Breathe Technologies, Inc. Methods and devices for providing inspiratory and expiratory flow relief during ventilation therapy
US8770193B2 (en) 2008-04-18 2014-07-08 Breathe Technologies, Inc. Methods and devices for sensing respiration and controlling ventilator functions
US8776793B2 (en) 2008-04-18 2014-07-15 Breathe Technologies, Inc. Methods and devices for sensing respiration and controlling ventilator functions
US8677999B2 (en) 2008-08-22 2014-03-25 Breathe Technologies, Inc. Methods and devices for providing mechanical ventilation with an open airway interface
US10252020B2 (en) 2008-10-01 2019-04-09 Breathe Technologies, Inc. Ventilator with biofeedback monitoring and control for improving patient activity and health
US10709864B2 (en) 2009-04-02 2020-07-14 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles with an outer tube
US9180270B2 (en) 2009-04-02 2015-11-10 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within an outer tube
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US11896766B2 (en) 2009-04-02 2024-02-13 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation with gas delivery nozzles in free space
US9675774B2 (en) 2009-04-02 2017-06-13 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles in free space
US9962512B2 (en) 2009-04-02 2018-05-08 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature
US10046133B2 (en) 2009-04-02 2018-08-14 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation for providing ventilation support
US11707591B2 (en) 2009-04-02 2023-07-25 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles with an outer tube
US10695519B2 (en) 2009-04-02 2020-06-30 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within nasal pillows
US10232136B2 (en) 2009-04-02 2019-03-19 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation for treating airway obstructions
US9132250B2 (en) 2009-09-03 2015-09-15 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US11154672B2 (en) 2009-09-03 2021-10-26 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US9301716B2 (en) 2009-09-09 2016-04-05 Fresenius Medical Care Deutschland Gmbh Method and apparatus for evaluating values representing a mass or a concentration of a substance present within the body of a patient
US10551370B2 (en) 2009-09-09 2020-02-04 Fresenius Medical Care Deutschland Gmbh Method and apparatus for evaluating values representing a mass or a concentration of a substance present within the body of a patient
EP2295097A1 (fr) * 2009-09-09 2011-03-16 Fresenius Medical Care Deutschland GmbH Procédé et appareil pour évaluer les valeurs représentant une masse ou une concentration de substance présente dans le corps d'un patient
AU2010294525B2 (en) * 2009-09-09 2015-09-17 Fresenius Medical Care Deutschland Gmbh Method and apparatus for evaluating values representing a mass or a concentration of a substance present within the body of a patient
WO2011029569A1 (fr) * 2009-09-09 2011-03-17 Fresenius Medical Care Deutschland Gmbh Procede et appareil d'evaluation de valeurs representant une masse ou une concentration d'une substance presente dans le corps d'un patient
US10099028B2 (en) 2010-08-16 2018-10-16 Breathe Technologies, Inc. Methods, systems and devices using LOX to provide ventilatory support
US9358358B2 (en) 2010-09-30 2016-06-07 Breathe Technologies, Inc. Methods, systems and devices for humidifying a respiratory tract
US8939152B2 (en) 2010-09-30 2015-01-27 Breathe Technologies, Inc. Methods, systems and devices for humidifying a respiratory tract
US10792449B2 (en) 2017-10-03 2020-10-06 Breathe Technologies, Inc. Patient interface with integrated jet pump
US12017002B2 (en) 2020-09-16 2024-06-25 Breathe Technologies, Inc. Patient interface with integrated jet pump

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