Detection appliance and method for observing sleep-related breathing disorders

• US 10,154,811 B2
• Filed: 09/03/2004
• Issued: 12/18/2018
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: ResMed Humidification Technologies GmbH (ResMed Incorporated)
• Original Assignee: ResMed R&D Germany GmbH (ResMed Incorporated)
• Inventors: Madaus, Stefan, Stauffenberg, Caspar Graf von, Vogele, Harald, Heidmann, Dieter, Klaus, Dieter
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US10/570,503
• Publication Number:
  US 20060276718A1
• Time in Patent Office: 5,219 Days
• Field of Search: 600300, 600301, 600481, 600529, 600534, 600537, 600538
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period

Abstract

A mobile detection appliance and a method for detecting and evaluating a measuring signal that is indicative of the breathing of a sleeping person are used in connection with the observation of sleep-related breathing disorders. Instruments for detecting signals that are indicative of the breathing of a patient are also used. Solutions that enable an especially reliable examination in terms of the occurrence of sleep-related sleeping disorders, especially in the usual surroundings of the person concerned, are provided. The mobile detection appliance includes a sensor device for detecting a nasal flow signal that is indicative of a nasal respiratory gas flow, and/or a respiratory flow signal that is indicative of an oral respiratory gas flow, in addition to an electronic data processing unit that includes a memory device and processes the respiratory flow signals that are indicative of the temporal course of the nasal and oral respiration. The data processing device stores data that is indicative of the temporal course of the respiratory flow signals.

Claims

1. A mobile detection appliance configured to record and evaluate data indicative of a respiratory condition of a user, the mobile detection appliance comprising:

a sensor configured to generate a respiratory flow signal based on at least one of an expiratory gas flow and an inspiratory gas flow received from a patient interface, the respiratory flow signal being indicative of the user'"'"'s respiratory gas flow;

a chest strap having (a) an adjacent surface serving in part as a user-contact surface when worn by the user and (b) a non-adjacent surface that is opposite the user-contact surface;

an electronic data processing unit which comprises a memory device and is configured to process the generated respiratory flow signal and a chest expansion signal generated using the chest strap, said electronic data processing unit being configured to store data that is indicative of a temporal course of the generated signals when the generated signals fulfill a certain criterion; and

a common housing with a port configured to receive said at least one of the expiratory gas flow and the inspiratory gas flow from the patient interface, wherein the common housing houses the sensor and the data processing unit, the common housing being selectively fastenable to the user so that the sensor and the data processing unit are securable as a unit to the user,

wherein the common housing comprises a first exterior surface and a second exterior surface, the first exterior surface being opposite the second exterior surface, and

wherein the first exterior surface is configured to be in contact with a body of a user when in use, and

wherein the second exterior surface is configured to be faced away from the body of the user and to be in contact with the adjacent surface of the chest strap so that the adjacent surface lies over the second exterior surface to retain the common housing against the user when in use, and

wherein the second exterior surface includes at least one detector, the at least one detector comprising a pressure or force sensor and configured to be in contact with the adjacent surface of the chest strap to detect force exerted by the chest strap upon the at least one detector to generate the chest expansion signal when in use.

2. A mobile detection appliance according to claim 1, wherein the data processing unit is configured to check whether the generated respiratory flow signal fulfils prescribed signal quality criteria.

3. A mobile detection appliance according to claim 1, wherein the data processing unit comprises a time-keeping device and data that is indicative of the respiratory flow signal is recorded in conjunction with time information.

4. A mobile detection appliance according to claim 1, wherein the data processing unit is provided with a data compression system.

5. A mobile detection appliance according to claim 1, wherein the data processing unit is configured such that storage of the data is initiated by a switching impulse triggered by the user.

6. A mobile detection appliance according to claim 1, wherein the data processing unit is configured to suppress storage of the data when the generated respiratory flow signal does not fulfill the certain criterion.

7. A mobile detection appliance according to claim 1, wherein the common housing further comprises a first pressure measurement connection at the port to that is connectable to a measurement cannula.

8. A mobile detection appliance according to claim 7, wherein the common housing further comprises a second pressure measurement connection configured to acquire a second pressure measurement signal.

9. A mobile detection appliance according to claim 1, wherein said sensor is configured to generate separate respiratory flow signals that are indicative of left and right nasal openings, respectively.

10. A mobile detection appliance according to claim 1, wherein the certain criterion comprises a predetermined periodicity criterion.

11. A mobile detection appliance according to claim 1, wherein the data processing unit is configured to perform a data entry indicative of a time location when the respiratory flow signal does not fulfill certain criteria.

12. A mobile detection appliance according to claim 1, wherein the data processing unit is configured to suppress recording of the generated respiratory flow signal and instead store data indicative of a time location when the generated respiratory flow signal does not fulfill the certain criterion.

13. A mobile detection appliance according to claim 1, wherein the common housing comprises a first loop feature projecting from the second exterior surface, the first loop feature configured to accept the chest strap and arranged to align the chest strap in a position over the at least one detector of the second exterior surface.

14. A mobile detection appliance according to claim 13, wherein common housing comprises a second loop feature projecting from the second exterior surface, the second loop feature configured to accept the chest strap and arranged to align the chest strap in the position over the at least one detector of the second exterior surface, the position over the at least one detector being between the first loop feature and the second loop feature.

15. A mobile detection appliance according to claim 14, wherein the second exterior surface comprises an additional detector comprising a pressure or force sensor and configured to be in contact with the adjacent surface of the chest strap to detect force exerted by the chest strap upon the at least one detector to generate a further chest expansion signal when in use.

16. A mobile detection appliance according to claim 1, wherein the data processing unit is configured to transmit the data that is stored to an external analysis system.

17. A mobile detection system comprising:

the mobile detection appliance of claim 1; and

the patient interface, the patient interface being configured to engage the user'"'"'s face and receive at least one of the expiratory gas flow from the user and the inspiratory gas flow from ambient gas.

18. A mobile detection device according to claim 1, wherein the first exterior surface of the common housing comprises electrode devices to directly contact skin of the user, the electrode devices configured to provide ECG signals from the user.

19. A mobile detection device according to claim 1, wherein the data processing unit is configured to generate evaluation characteristics based on the respiratory flow signal and the chest expansion signal, and wherein the evaluation characteristics are subjected to an associative analysis.

20. A mobile detection device according to claim 1, wherein the sensor is in fluid communication with the port.

21. Method for acquiring and evaluating measurement signals while a user is asleep, the measurement signals being indicative of a respiratory condition of the user, comprising:

providing a chest expansion monitor for use with a chest strap, the chest strap having (a) an adjacent surface serving in part as a user-contact surface when worn by the user and (b) a non-adjacent surface that is opposite the user-contact surface, (b) a sensor and (c) an electronic data processing unit to the user,

wherein the chest expansion monitor, the sensor and the electronic data processing unit are commonly housed within a common housing of a mobile detection appliance so that the chest expansion monitor, the sensor and the electronic data processing unit are securable to the user as a unit;

providing at least one of an expiratory gas flow from the user and an inspiratory gas flow from ambient gas to the sensor that is commonly housed within the mobile detection appliance;

providing chest expansion signals to the chest expansion monitor, the chest expansion signals being indicative of an expansion of the user'"'"'s chest;

generating the measurement signals within the mobile detection appliance based on the chest expansion signals and at least one of the expiratory gas flow and the inspiratory gas flow;

generating evaluation characteristics from said measurement signals through use of several analysis systems; and

generating at least one evaluation result from a result generation step based thereon in which the evaluation characteristics are subjected to an associative analysis, wherein said measurement signals are acquired by the data processing unit in a course of a signal acquisition phase preceding the associative analysis and stored when they fulfill a certain criterion,

wherein the common housing comprises a first exterior surface and a second exterior surface, the first exterior surface being opposite the second exterior surface, and

wherein the first exterior surface is configured to be in contact with a body of a user when in use, and

wherein the second exterior surface is configured to be faced away from the body of the user and to be in contact with the adjacent surface of the chest strap so that the adjacent surface lies over the second exterior surface to retain the common housing against the user when in use, and

wherein the second exterior surface includes at least one detector, the at least one detector comprising a pressure or force sensor and configured to be in contact with the adjacent surface of the chest strap to detect force exerted by the chest strap upon the at least one detector to generate the chest expansion signal when in use.

22. Method according to claim 21, wherein apnea indicators are included among the evaluation characteristics.

23. Method according to claim 21, wherein hypopnea indicators are included among the evaluation characteristics.

24. Method according to claim 21, wherein flow limitation indicators are included among the evaluation characteristics.

25. Method according to claim 21, wherein a contributing characteristic predominantly included among the evaluation characteristics is generated within a generation time window that is smaller than an association time window used in the associative analysis.

26. Method according to claim 21, wherein a physiological characterization of the user according to obstructive, central and/or mixed respiratory disorders occurs on a basis of the associative analysis.

27. Method according to claim 21, wherein the evaluation characteristics are generated on a basis of breathing stability criteria.

28. Method according to claim 21, wherein the evaluation characteristics are generated on a basis of statistical analysis procedures.

29. Method according to claim 21, wherein the evaluation characteristics are generated as an array of characteristics.

30. Method according to claim 21, wherein an evaluation characteristic is generated from a duration of normal respiration phases and/or normal respiration characterizing features and/or features representing a duration of regular or irregular respiration phases and/or regular and/or irregular features.

31. A method according to claim 21, further comprising:

classifying said acquired measurement signals as invalid when said acquired measurement signals do not fulfill the certain criterion;

suppressing storage of the acquired measurement signals that are classified as invalid; and

storing data indicative of time locations associated with respective invalid measurement signals.

32. A method according to claim 21, wherein the sensor and the electronic data processing unit are commonly housed within a housing of the mobile detection appliance, and wherein said at least one of the expiratory gas flow from the user and the inspiratory gas flow from ambient gas is provided to the sensor by way of a port in the housing of the mobile detection appliance.