Oral appliance with auto negative pressure control and method thereof

• US 8,616,208 B2
• Filed: 09/17/2009
• Issued: 12/31/2013
• Est. Priority Date: 10/29/2008
• Status: Active Grant

• Current Assignee: Somnics inc.
• Original Assignee: Industrial Technology Research Institute
• Inventors: Chen, Chung-Chu, Huang, Chen-Ning, Yu, Tung-Ming, Lin, Chen-Liang
• Primary Examiner(s): Ostrup, Clinton T
• Application Number:
  US12/561,364
• Publication Number:
  US 20100101583A1
• Time in Patent Office: 1,566 Days
• Field of Search: 128/205.19, 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/205.23, 128/206.21, 128/206.29
• US Class Current: 128/205.19
• 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. A method applied in an oral appliance, for automatic controlling negative pressure supplied to a user'"'"'s oral cavity, the oral appliance comprising:

a sensing unit, a physiological status extraction unit, a negative pressure source, an oral interface, and a negative pressure control unit, and the method comprising;

sensing a physiological signal from a user and outputting the physiological signal by the sensing unit;

providing a negative pressure to an oral interface interfacing with the user'"'"'s oral cavity by the negative pressure source; and

extracting a physiological status based on the physiological signal by the physiological status extraction unit;

automatically controlling the negative pressure provided to the user'"'"'s oral cavity based on the physiological status by the negative pressure control unit;

wherein the method further comprising;

determining a breath phase of the user in exhalation or in inhalation, and automatically turning on or increasing the negative pressure in inhalation phase, and automatically maintaining or turning off or decreasing the negative pressure in exhalation phase.

2. The method as in claim 1, wherein the physiological status is selected from the group consisting 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.

3. The method as in claim 1, wherein the step of sensing a physiological signal from the user and outputting the physiological signal includes:

sensing the physiological signal by a sensing unit which is selected from the group consisting 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.

4. The method according to claim 1, wherein the step of automatically controlling the negative pressure is performed by selected from the group consisting 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.

5. The method as in claim 1, further comprising:

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

6. The method as in claim 1, further comprising:

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

7. The method as in claim 1, further comprising:

determining the user in rapid eye movement period.

8. The method as in claim 1, further comprising:

determining the user in muscle relaxation period.

9. The method as in claim 1, further comprising:

determining if the user has snore sound.

10. The method as in claim 1, further comprising:

determining if the user has airway pressure oscillation.

11. The method as in claim 1, further comprising:

determining if the user has oxygen desaturation.

12. The method as in claim 1, further comprising:

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

13. The method as in claim 1, further comprising:

determining if the user has abnormal breathing events.

14. The method as in claim 1, further comprising:

determining if the user has high heart rate variability.

15. The method as in claim 1, further comprising:

determining if the user has oral suction intent.

16. The method as in claim 1, further comprising:

determining if the user has open mouth intent.

17. The method as in claim 1, further comprising:

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

determining an optimized pressure setting with the least breathing disorder events corresponding to a plurality of breaths patterns of the user.

18. The method as in claim 17, wherein the negative pressure supplied is adjusted based on whether the user abnormal breathing events.

19. The method as in claim 18, wherein automatically turn on or increase the negative pressure if an abnormal breathing event is detected, and automatically maintain or turn off or decrease the negative pressure if an abnormal breathing event is not detected.

20. The method as in claim 1, wherein the negative pressure supplied is adjusted based on whether the user has abnormal breathing events.

21. The method as in claim 20, wherein automatically turn on or increase the negative pressure if an abnormal breathing event is detected, and automatically maintain or turn off or decrease the negative pressure if an abnormal breathing event is not detected.