Adaptively controlled mandibular positioning device and method of using the device

• US 6,273,859 B1
• Filed: 06/08/1999
• Issued: 08/14/2001
• Est. Priority Date: 11/01/1995
• Status: Expired due to Fees

• Current Assignee: University Technologies International, Inc.
• Original Assignee: University Technologies International, Inc.
• Inventors: Remmers, John E., Platt, Ronald S., Hajduk, Eric A.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/327,497
• Time in Patent Office: 798 Days
• Field of Search: 607/42, 126/840, 600/534-536, 600/538, 600/595, 600/529
• US Class Current: 600/529
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user

Abstract

The present invention relates to systems and methods for automatically and continuously regulating the amount of mandibular displacement to an optimal value during obstructive sleep apnea treatment. Obstructive sleep apnea therapy is implemented by a device which automatically reevaluates an applied mandibular displacement and continually searches for a minimum displacement required to adequately distend a patient'"'"'s pharyngeal airway. The minimum optimal displacement varies with body position, stage of sleep throughout the night, the patient'"'"'s body weight, and whether alcohol or sleeping medicine has been ingested.

Claims

1. A method for adaptively controlling mandibular displacement for the treatment of obstructive sleep apnea in a patient, comprising:

(a) monitoring the patient for evidence of obstruction of the patient'"'"'s airway;

(b) automatically displacing the patient'"'"'s mandible if evidence of obstruction is detected; and

(c) repeating steps (a) and (b) until evidence of obstruction is eliminated or reduced below a predetermined value.

2. The method of claim 1 wherein the patient'"'"'s mandible is displaced a predetermined increment.

3. The method of claim 2 wherein the patient is monitored for a time in the range of 10 seconds to 4 minutes after the mandible has been displaced.

4. The method of claim 2 wherein the patient is monitored for a time in the range of 2 to 4 minutes after the mandible has been displaced.

5. The method of claim 2 wherein the increment is in the range of 0.25 to 2 millimeters.

6. The method of claim 2 wherein the increment is in the range of 0.5 to 1 millimeter.

7. The method of claim 1 further comprising:

detecting airflow in the patient'"'"'s airway;

averaging said airflow information over a predetermined period; and

comparing the airflow in the patient'"'"'s airway during a first test period after the mandible is displaced to the averaged airflow information to determined if evidence of obstruction is above the predetermined value.

8. The method of claim 7 wherein the predetermined period is in the range of 2 to 10 breaths.

9. The method of claim 7 wherein the predetermined period is in the range of 3 to 5 breaths.

10. The method of claim 1 further comprising:

detecting airflow in the patient'"'"'s airway in predetermined increments of time;

identifying periods of inspiration and expiration;

extracting features of the patient'"'"'s airway during at least one of said periods of inspiration;

identifying airflow profiles based on said detected airflow and said extracted features;

determining a first mandible displacement which produces a first predetermined airflow profile;

introducing incremental mandible displacements to determine a second mandible displacement which produces a second predetermined airflow profile; and

setting the patient'"'"'s mandible at the second mandible displacement.

11. The method of claim 10, wherein the extracting step further includes a step of:

determining an inspiratory airflow profile for the period of inspiration.

12. The method of claim 11, wherein the step of determining an inspiratory airflow profile further includes the step of:

calculating a roundness feature and a flatness feature for the period of inspiration.

13. A method for adaptively controlling mandibular displacement for the treatment of obstructive sleep apnea in a patient, comprising the steps of:

detecting obstruction in a patient'"'"'s upper airway system;

identifying periods of inspiration and expiration for the patient; and

incrementally adjusting a patient'"'"'s mandible in response to the obstruction information detected during the period of inspiration.

14. The method of claim 13, wherein the step of adjusting further includes the steps of:

identifying a mandibular position at which a significant obstruction occurs during said inspiration; and

identifying an optimum mandibular position for eliminating said obstruction during said inspiration.

15. The method of claim 14, wherein said steps of identifying the mandibular position and the optimum mandibular position further includes the step of:

introducing incremental mandibular displacements;

extracting characteristic features of said upper airway system during inspiration;

using said extracted characteristics to identify the optimum mandibular position and the mandibular position at which the significant obstruction occurs.

16. The method of claim 13, wherein the step of adjusting is performed by identifying relative changes in airflow during said step of detecting.

17. The method of claim 13, wherein the step of adjusting further includes the steps of:

extracting features indicative of airflow resistance in said upper airway system.

18. A system for adaptively controlling mandibular displacement for the treatment of obstructive sleep apnea in a patient, comprising:

an adjustable mandibular displacement device;

a unit which detects evidence of obstruction of the patient'"'"'s airway; and

a control system for adaptively controlling the adjustable mandibular displacement device in response to the detecting unit.

19. The system of claim 18 wherein the adjustable mandibular displacement device comprises:

an upper dental appliance;

a lower dental appliance having a mounting bracket extending therefrom; and

an actuator attached to the mounting bracket and in contact with the upper dental appliance.

20. The system of claim 18 wherein the detecting unit comprises an oxygen saturation monitor.

21. The system of claim 18 wherein the detecting unit comprises a sound monitor.

22. The system of claim 18 wherein the detecting unit comprises an airflow monitor.

23. A method for adaptively controlling mandibular displacement for the treatment of obstructive sleep apnea in a patient, comprising:

(a) monitoring the patient for evidence of obstruction of the patient'"'"'s airway;

(b) displacing the patient'"'"'s mandible by adjusting a mandibular positioning device in the patient'"'"'s mouth if evidence of obstruction is detected and

(c) repeating steps (a) and (b) until evidence of obstruction is eliminated or reduced below a predetermined value.

24. The method of claim 23 wherein the patient'"'"'s mandible is displaced a predetermined increment.

25. The method of claim 24 wherein the patient is monitored for a time in the range of 10 seconds to 4 minutes after the mandible has been displaced.

26. The method of claim 24 wherein the patient is monitored for a time in the range of 2 to 4 minutes after the mandible has been displaced.

27. The method of claim 24 wherein the increment is in the range of 0.25 to 2 millimeters.

28. The method of claim 24 wherein the increment is in the range of 0.5 to 1 millimeter.

29. The method of claim 23 further comprising:

detecting airflow in the patient'"'"'s airway;

averaging said airflow information over a predetermined period; and

comparing the airflow in the patient'"'"'s airway during the first breath after the mandible is displaced to the averaged airflow information to determined if evidence of obstruction is above the predetermined value.

30. The method of claim 29 wherein the predetermined period is in the range of 2 to 10 breaths.

31. The method of claim 29 wherein the predetermined period is in the range of 3 to 5 breaths.