Mask assembly with integrated sensors

• US 7,575,005 B2
• Filed: 05/18/2005
• Issued: 08/18/2009
• Est. Priority Date: 05/18/2004
• Status: Active Grant

• Current Assignee: Natus Medical Incorporated
• Original Assignee: Excel-Tech Ltd. (Natus Medical Incorporated)
• Inventors: Wu, Jianping, Kurtz, Ronald Leon, Mumford, John Robert
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US11/131,284
• Publication Number:
  US 20050268916A1
• Time in Patent Office: 1,553 Days
• Field of Search: 128/205.23, 128/206.21, 128/205.25, 128/206.11, 128/206.12, 128/206.18, 128/206.24, 128/206.26, 128/206.27, 128/206.28, 128/207.11, 128/207.13, 128/27.18, 600/534, 600/537, 600/538, 600/544, 600/545
• US Class Current: 128/205.23
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/435 partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/62 Posture

Abstract

Embodiments of the invention relate to a mask assembly for use in treatment systems for treating obstructive sleep apnea using continuous positive air pressure (CPAP). The mask assembly comprises a mask or nasal interface for supplying gas to the nose of a wearer of the mask assembly. The mask assembly also comprises a strap or harness attached to the mask for securing the mask assembly to the wearer and sensors located on the mask assembly for measuring physiological signals of the wearer. These physiological signals are communicated to a monitoring unit which, in association with a CPAP device, serves to determine the efficacy of the CPAP treatment and to vary operational parameters of the treatment.

Claims

1. A mask assembly adapted to be worn by a wearer for treatment of a medical condition, comprising:

a mask shaped to fit over at least the nose of the person, the mask including a gas inlet for providing pressurized gas to the wearer;

a harness assembly attached to the mask, the harness assembly including a plurality of straps for securing the mask assembly to the head of the wearer; and

sensors located on at least one of the mask and the harness assembly for providing physiological information about the person for determining efficacy of treatment and/or for varying operational parameters of the treatment, wherein the sensors include a first electrode for positioning adjacent a nasion area of the head of the wearer, a second electrode for positioning at a first forehead area of the wearer, and a third electrode for positioning at a second forehead area laterally separated from the first forehead area.

2. The mask assembly of claim 1, wherein the first, second and third electrodes are positioned in a triangular configuration.

3. The mask assembly of claim 1, wherein the mask includes a vertical mounting plate extending upwardly from the top of the mask and wherein the first electrode is located on the mask and a fourth electrode is located on the vertical mounting plate at the central forehead region of the person.

4. The mask assembly of claim 1, wherein the mask includes a vertical mounting plate extending upwardly from the top of the mask and a forehead support member attached horizontally therewith, the forehead support member having vertically elongated apertures at either end, and wherein the harness assembly includes right and left upper straps that engage the corresponding elongated aperture on the forehead support member, wherein the first electrode is located on the mask, the second electrode is located the upper right strap horizontally offset with respect to the center of the right eye of the wearer, and the third electrode is located on the upper left strap horizontally offset with respect to the center of the left eye of the wearer.

5. The mask assembly of claim 1, wherein the mask includes a vertical mounting plate extending upwardly from the top of the mask and a forehead support member attached horizontally therewith, the forehead support member having vertically elongated apertures at either end, and wherein the harness assembly includes right and left upper straps that engage the corresponding elongated aperture on the forehead support member, right and left lower straps that engage elongated apertures at the bottom of the mask, a right vertical strap behind the right ear of the wearer that connects the right upper strap to the right lower strap and a left vertical strap behind the left ear of the wearer that connects the left upper strap to the left lower strap, the right and left vertical straps located proximally to the right and left mastoids of the wearer, wherein the second electrode is located at the upper right strap horizontally offset with respect to the center of the right eye of the wearer, the third electrode is located at the upper left strap horizontally offset with respect to the center of the left eye of the wearer, and a fourth electrode is located at one of the right and left vertical straps proximally to the corresponding mastoid of the wearer.

6. The mask assembly of claim 1, wherein the mask includes a vertical mounting plate extending upwardly from the top of the mask and a forehead support member attached horizontally therewith, the forehead support member having vertically elongated apertures at either end, and wherein the harness assembly includes right and left upper straps that engage the corresponding elongated aperture on the forehead support member, right and left lower straps that engage elongated apertures at either side near the bottom of the mask, a right vertical strap behind the right ear of the wearer that connects the right upper strap to the right lower strap and a left vertical strap behind the left ear of the wearer that connects the let upper strap to the left lower strap, the right and left vertical straps located proximally to the right and left mastoids of the wearer, wherein a fourth electrode is located at the vertical mounting plate at the central forehead region of the wearer and a fifth electrode is located at one of the right and left vertical straps proximally to the corresponding mastoid of the wearer.

7. The mask assembly of claim 1, wherein the mask includes a forehead support member extending vertically from the top of the mask, the forehead support member having right and left horizontal ends that extends above the eyebrows of the wearer, wherein the first electrode is located on the mask, the second electrode is located on the right horizontal end of the forehead support member above the right eyebrow of the wearer and horizontally offset with respect to the center of the right eye of the wearer, and the third electrode is located on the left horizontal end of the forehead support member above the left eyebrow of the wearer and horizontally offset with respect to the center of the left eye of the wearer.

8. The mask assembly of claim 1, wherein the sensors further include a blood oximeter sensor.

9. The mask assembly of claim 8, wherein the mask includes a forehead support member extending vertically therefrom, the blood oximeter sensor being located at the forehead support member in close proximity to the forehead of the wearer.

10. The mask assembly of claim 1, wherein the sensors further include a pressure transducer sensor disposed within the mask.

11. The mask assembly of claim 1, wherein the sensors further include a position sensor.

12. The mask assembly of claim 1, wherein the mask includes a forehead support member extending vertically therefrom, the position sensor being located at the forehead support member.

13. The mask assembly of claim 1, wherein the sensors further include at least two of a blood oximeter sensor, a pressure transducer and a position sensor.

14. The mask assembly of claim 1, wherein the mask assembly further includes a remote processing unit connected to the sensors for processing the physiological information.

15. The mask assembly of claim 14, wherein the remote processing unit includes a sleep efficacy algorithm for processing the physiological information and generating a sleep information profile for the wearer.

16. The mask assembly of claim 14, wherein the remote processing unit includes a wireless transceiver for wirelessly transmitting signals related to the physiological information, and a battery for providing power to the remote processing unit.

17. A mask assembly adapted to be worn by a wearer for treatment of a medical condition, comprising:

a mask shaped to fit over at least the nose of the wearer, the mask including a gas inlet for providing pressurized gas to the wearer;

a harness assembly attached to the mask, the harness assembly including a plurality of straps for securing the mask assembly to the head of the wearer; and

a plurality of electrodes located on the inside of at least one of the mask and the harness assembly and being spaced with regards to one another for sensing physiological information including at least one of the EEG, EMG and EOG of the wearer whereby the physiological information is used to monitor the efficacy of treatment or to vary operational parameters of the treatment, wherein the sensors include a first electrode for positioning adjacent a nasion area of the head of the wearer, a second electrode for positioning at a first forehead area of the wearer, and a third electrode for positioning at a second forehead area laterally separated from the first forehead area.

18. A mask assembly adapted to be worn by a wearer for treatment of a medical condition, the mask assembly including sensors located on the mask assembly for sensing physiological information from the wearer and a remote processing unit located on the mask assembly and connected to the sensors for processing the physiological information, wherein the sensors include a first electrode for positioning adjacent a nasion area of the head of the wearer, a second electrode for positioning at a first forehead area of the wearer, and a third electrode for positioning at a second forehead area laterally separated from the first forehead area.

19. A mask assembly for wearing by a wearer during treatment of a medical condition, the mask assembly comprising:

a nasal interface for providing pressurized gas to the wearer, the nasal interface comprising a gas inlet for receiving a source of gas and a gas outlet for providing gas directly to the nares of the wearer;

at least one strap connected to the nasal interface for securing the mask assembly to the head of the wearer; and

a forehead member for location on a forehead of the wearer, the forehead member comprising sensors for measuring physiological signals of the wearer during treatment of the medical condition, wherein the sensors include a first electrode for positioning adjacent a nasion area of the head of the wearer, a second electrode for positioning at a first forehead area of the wearer, and a third electrode for positioning at a second forehead area laterally separated from the first forehead area.

20. The mask assembly of claim 19, wherein the first, second and third electrodes are disposed so as to contact the skin of the forehead of the wearer during the treatment and to sense the physiological signals.

21. The mask assembly of claim 20, wherein the second electrode is disposed on the forehead member so as to overlie a portion of the forehead of the wearer vertically above the nasion.

22. The mask assembly of claim 19, wherein the forehead member, when worn by the wearer, extends laterally across the wearer'"'"'s forehead and has a lower portion that at least partly overlies the nasion area of the wearer.

23. The mask assembly of claim 22, wherein the first electrode is disposed on the lower portion of the forehead member and the second and third electrodes are disposed on lateral extensions of the forehead member.

24. An electrode placement assembly for locating electrodes on a forehead of a wearer of the electrode placement assembly, comprising:

a forehead placement assembly dimensioned to extend laterally across the forehead of the wearer and having a lower portion for at least partly overlying a nasion area of the wearer;

at least one strap connected to the forehead placement assembly for securing the electrode placement assembly to the wearer; and

a plurality of electrodes positioned on at least one of the forehead placement assembly and the at least one strap so that the plurality of electrodes contact the skin of the wearer, wherein the sensors include a first electrode for positioning adjacent a nasion area of the head of the wearer, a second electrode for positioning at a first forehead area of the wearer, and a third electrode for positioning at a second forehead area laterally separated from the first forehead area.

25. The assembly of claim 24, further comprising attachment means for attaching a nasal interface to the electrode placement assembly so that the nasal interface is positioned to provide gas to the nares of the wearer.

26. The assembly of claim 25, wherein the attachment means comprises flexible attachment members for attaching the nasal interface to the at least one strap.

27. The assembly of claim 25, wherein the attachment means comprises a connector member positioned on the forehead placement assembly for connecting the nasal interface to the forehead placement assembly.

28. The assembly of claim 24, wherein the forehead placement assembly comprises a flexible unitary plate.

29. The assembly of claim 24, further comprising a fourth electrode located on the forehead placement assembly to be positioned on the forehead of the wearer between the second and third electrodes.