ORAL APPLIANCE WITH AUTO NEGATIVE PRESSURE CONTROL AND METHOD THEREOF

• US 20100101583A1
• Filed: 09/17/2009
• Published: 04/29/2010
• Est. Priority Date: 10/29/2008
• Status: Active Grant

• Current Assignee: Somnics inc.
• Original Assignee: Industrial Technology Research Institute
• Inventors: Chen, Chung-Chu, Lin, Chen-Liang, Huang, Chen-Ning, Yu, Tung-Ming
• Granted Patent: US 8,616,208 B2
• Time in Patent Office: Days
• US Class Current: 128/207.140
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0806 by whole-body plethysmography measuring blood flow using plethysmography A61B5/0295; impedance plethysmography A61B5/053; measuring volume of the body or parts thereof A61B5/1073
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 16/0009 with sub-atmospheric pressure, e.g. during expiration
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0042 in the expiratory circuit
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/14 : Electro-oculogram [EOG]
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity

Abstract

A method for automatically controlling negative pressure supplied in oral cavity, for relieving sleep apnea and snoring is provided. The method includes: sensing a physiological signal from the user and outputting the sensed physiological signal; extracting a physiological status based on said sensed physiological signal; and automatically controlling said negative pressure provided to the user'"'"'s oral cavity based on said physiological status.

Claims

1. An oral appliance with automatic negative pressure control, comprising:

a sensing unit, for sensing a physiological signal from a user and outputting said sensed physiological signal;

a physiological status extraction unit, coupled to said sensing unit, for extracting a physiological status based on said sensed physiological signal from said sensing unit;

a negative pressure source, for providing a negative pressure;

an oral interface, for connecting said negative pressure source and interfacing with oral cavity, and

a negative pressure control unit, coupled to said physiological status extraction unit and said negative pressure source, for automatically controlling said negative pressure source based on said physiological status provided from said physiological status extraction unit.

2. The oral appliance as in claim 1, wherein said sensing unit includes at least one or any combination of a body position sensor, an accelerator, a gravity sensor, a tilt sensor, a motion sensor, electrodes, a microphone, a piezo-transducer, a pressure sensor, an oximeter, a CO2 sensor, a thermistor, a hotwire, a flow sensor, a respiratory inductive plethysmograph, a strain gauge and an impedance pneumograph.

3. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines the user'"'"'s body position in upright, supine, prone or side posture.

4. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines the user'"'"'s sleep/wake status.

5. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines the user in rapid eye movement period.

6. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines the user in muscle relaxation period.

7. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has snore sound.

8. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has airway pressure oscillation.

9. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has oxygen desaturation.

10. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has lower or absent tidal-end CO2 concentration.

11. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has abnormal breathing events.

12. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has high heart rate variability.

13. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has oral suction intent.

14. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines if the user has open mouth intent.

15. The oral appliance as in claim 1, wherein said negative pressure control unit automatically controls said negative pressure source by at least one or any combination of turning pressure on, turning pressure off, setting pressure high, setting pressure low, increasing pressure, decreasing pressure, intermittent, on-demand, auto relaxation, auto titration and maintaining pressure.

16. The oral appliance as in claim 1, wherein:

said physiological status extraction unit determines the user'"'"'s breathe phase in exhalation or in inhalation.

17. The oral appliance as in claim 1, wherein:

said negative pressure control unit providing different negative pressure to a patient'"'"'s oral cavity during a titrating period of time; and

said physiological status extraction unit determining an optimized pressure setting with least breathing disorder events corresponding to a patient'"'"'s breaths patterns.

18. A method applied in an oral appliance, for automatic controlling negative pressure supplied to a user'"'"'s oral cavity, the method comprising:

sensing a physiological signal from the user and outputting the sensed physiological signal;

extracting a physiological status based on said sensed physiological signal; and

automatically controlling said negative pressure provided to the user'"'"'s oral cavity based on said physiological status.

19. The method as in claim 18, wherein said physiological status includes at least one or any combination of body posture, sleep/wake status, rapid eye movement period, muscle relaxation period, snore sound, oxygen desaturation, CO₂ concentration, abnormal breathing event, breath phase, heart rate variability, oral suction intent and open mouth intent.

20. The method as in claim 18, wherein said step of sensing a physiological signal from the user and outputting said sensed physiological signal includes:

sensing the physiological signal by a sensing unit which includes at least one or any combination of a body position sensor, an accelerator, a gravity sensor, a tilt sensor, a motion sensor, electrodes, a microphone, a piezo-transducer, a pressure sensor, an oximeter, a CO2 sensor, a thermistor, a hotwire, a flow sensor, a respiratory inductive plethysmograph, a strain gauge and an impedance pneumograph.

21. The method according to claim 18, wherein the step of automatically controlling said negative pressure is performed by at least one or any combination of turning pressure on, turning pressure off, setting pressure high, setting pressure low, increasing pressure, decreasing pressure, intermittent, on-demand, auto relaxation, auto titration and maintaining pressure.

22. The method as in claim 18, further comprising:

determining the user'"'"'s breath phase in exhalation or in inhalation.

23. The method as in claim 18, further comprising:

determining the user'"'"'s body position in upright, supine, prone or side posture.

24. The method as in claim 18, further comprising:

determining the user'"'"'s sleep/wake status.

25. The method as in claim 18, further comprising:

determining the user in rapid eye movement period.

26. The method as in claim 18, further comprising:

determining the user in muscle relaxation period.

27. The method as in claim 18, further comprising:

determining if the user has snore sound.

28. The method as in claim 18, further comprising:

determining if the user has airway pressure oscillation.

29. The method as in claim 18, further comprising:

determining if the user has oxygen desaturation.

30. The method as in claim 18, further comprising:

determining if the user has lower or absent tidal-end CO2 concentration.

31. The method as in claim 18, further comprising:

determining if the user has abnormal breathing events.

32. The method as in claim 18, further comprising:

determining if the user has high heart rate variability.

33. The method as in claim 18, further comprising:

determining if the user has oral suction intent.

34. The method as in claim 18, further comprising:

determining if the user has open mouth intent.

35. The method as in claim 18, further comprising:

providing different negative pressure to a patient'"'"'s oral cavity during a titrating period of time; and

determining an optimized pressure setting with least breathing disorder events corresponding to a patient'"'"'s patterns of a plurality of breaths.

36. A method applied in an oral appliance, for automatic controlling a negative pressure supplied to a user'"'"'s oral cavity, the method comprising:

automatically controlling said negative pressure provided to the user'"'"'s oral cavity based on a time interval control.

37. The method as in claim 36, said time interval control further comprising:

automatically turning said negative pressure on at a predetermined time interval after power on.

38. The method as in claim 36, said time interval control further comprising:

gradually increasing said negative pressure to a predetermined value at a predetermined time interval after power on.

39. The method as in claim 36, said time interval control further comprising:

intermittently turning said negative pressure off and on at predetermined time periods.

40. The method as in claim 36, said time interval control further comprising:

periodically decreasing said negative pressure to a low value for a predetermined time interval and then resuming to a high value.