Bio-mask with integral sensors

• US 8,281,787 B2
• Filed: 12/15/2009
• Issued: 10/09/2012
• Est. Priority Date: 12/16/1999
• Status: Expired due to Fees

• Current Assignee: Compumedics Limited
• Original Assignee: Compumedics Limited
• Inventors: Burton, David
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US12/638,891
• Publication Number:
  US 20100147304A1
• Time in Patent Office: 1,029 Days
• Field of Search: 128/207.11, 128/206.21, 128/204.21, 128/206.12, 128/205.23, 128/206.27, 128/206.28, 600/508, 600/529, 600/537, 600/538, 600/545, 600/534, 600/544
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/0878 using temperature sensing means
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/386 Accessories or supplementary instruments therefor
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0694 Chin straps
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/08 Other bio-electrical signals
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/62 : Posture
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity

Abstract

A system including a mask to detect an EEG signal and to deliver a gas, the mask having a forehead support extending from the body and adapted to contact a forehead surface of the patient during use, the forehead support having a plurality of sensors located thereon for detecting electrophysiological signals of the patient, with the plurality of sensors including EEG sensors positioned proximate to FP1/FP2 standard electrode placement positions of the patient, a gas delivery device in fluid communication with the mask and having an adjustable gas output, and a control system for determining a sleep stage from EEG signals detected by the mask and adjusting a gas delivery device based on the sleep stage.

Claims

1. A mask assembly comprising:

a body having an internal surface, an external surface, and a perimeter surface; and

a forehead support connected to the body;

a support bar connected to the forehead support and extending in generally lateral directions from the forehead support to define a pair of sensor sites on said forehead support, with one of the pair of sensor sites being proximate to a FP1 standard electrode placement position of a patient and the other of the pair of sensor sites being proximate to a FP2standard electrode placement position of said patient;

a pair of EEG sensors at ends of said support bar, with one of the pair of EEG sensors being held by the support bar at said FP1 standard electrode placement position and the other of the pair of EEG sensors being held by the support bar at said FP2 standard electrode placement position;

a control system adapted to receive a signal from said pair of EEG sensors, said control system determining said patient'"'"'s sleep stage based at least in part on said signal; and

a gas delivery device in communication with said control system, wherein said control system is adapted to adjust a gas delivery setting based upon a control system determination of said patient'"'"'s sleep stage, such that said gas delivery device delivers gas to the patient based on the control system determination of said patient'"'"'s sleep stage.

2. The assembly of claim 1, wherein the perimeter surface includes a padding material having a thermosensitive coating.

3. The assembly of claim 1 wherein wires connected to said pair of EEG sensors pass through an aperture of said support bar forehead.

4. The assembly of claim 1, and wherein an SPO2 sensor is located on the forehead support bar.

5. The assembly of claim 1, wherein the pair of EEG sensors includes pads comprised of a conductive carbonized rubber material.

6. The assembly of claim 1, and further comprising a strap extending from the mask, and wherein a physiological sensor is located on the strap.

7. The assembly of claim 5, wherein a portion of the pads is adapted to measure EOG.

8. A gas delivery system comprising:

a mask comprising a mask body having an internal surface, an external surface, and a perimeter surface;

a forehead support extending from the body and adapted to contact a forehead surface of a patient during use, a support bar connected to the forehead support and extending in generally lateral directions from the forehead support to define a pair of sensor sites at ends of said support bar, with one of the pair of sensor sites being proximate to a FP1 standard electrode placement position of said patient and the other of the pair of sensor sites being proximate to a FP2 standard electrode placement position of said patient;

a pair of EEG sensors, with one of the pair of EEG sensors being held by the support bar at said FP1 standard electrode placement position and the other of the pair of EEG sensors being held by the support bar at said FP2 standard electrode placement position;

a gas delivery device having an adjustable gas delivery setting; and

a control system in communication with the gas delivery device and the pair of EEG sensors, the control system adapted to determine a sleep stage of the patient and to adjust a gas delivery setting based upon a determined sleep stage.

9. The system of claim 8, further comprising a EMG sensor at said support bar.

10. The system of claim 8, further comprising a ECG sensor at said support bar.

11. The system of claim 10, and further comprising a SPO2 sensor connected to the mask.

12. The system of claim 8, wherein wires connected to said pair of EEG sensors pass through an aperture in said support bar.

13. The system of claim 8, wherein the control system is also adapted to determine patient arousal.

14. The system of claim 8, wherein the control system determines arousal by calculating PTT values from a SPO2 reading and a ECG reading.

15. The system of claim 8, wherein the control system determines arousal by analyzing cortical and subcortical EEG signals.

16. The system of claim 8, wherein the control system is provided in communication with a cardiac pacemaker, said control system being adapted to adjust the gas delivery based on a signal from the cardiac pacemaker.

17. A method of delivering gas comprising:

providing a mask adapted to detect an EEG signal and to deliver a gas, the mask comprising a mask body having an internal surface, an external surface, and a perimeter surface;

providing a forehead support extending from the body and adapted to contact a forehead surface of a patient during use, the forehead support having a plurality of sensors located thereon for detecting electrophysiological signals of the patient, with at least one of said plurality of sensors being a first EEG sensor positioned proximate to a FP1 standard electrode placement position of said patient and a second of said plurality of sensors being a second EEG sensor positioned proximate to a FP2 standard electrode placement position of said patient;

providing a gas delivery device in fluid communication with the mask and having an adjustable gas output;

determining a sleep stage from EEG signals detected by the mask; and

adjusting the output from the gas delivery device based on the sleep stage, by the use of a control system adapted to adjust a gas delivery setting based upon a determined sleep stage.

18. The method of claim 17, wherein said determining a sleep state includes determining arousal.

19. The method of claim 18, wherein said determining arousal includes calculating PTT values from a SPO2 reading and a ECG reading of the patient.

20. The method of claim 18, wherein determining arousal includes analyzing cortical and subcortical EEG signals of the patient.

21. The method of claim 17, wherein a processor is provided in communication with the gas delivery device and a cardiac pacemaker, said processor being adapted to adjust the gas delivery based on a signal from the cardiac pacemaker.