Remote-controlled mandibular positioning device and method of using the device

• US 5,826,579 A
• Filed: 10/25/1996
• Issued: 10/27/1998
• Est. Priority Date: 11/01/1995
• Status: Expired due to Term

• Current Assignee: University Technologies International, Inc.
• Original Assignee: University Technologies International, Inc.
• Inventors: Lowe, Alan A., Remmers, John E., Platt, Ronald S., Hajduk, Eric A.
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US08/736,900
• Time in Patent Office: 732 Days
• Field of Search: 128/848, 128/859-862, 128/323, 128/534-536, 128/544-546
• US Class Current: 128/848
• 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

A remote-controlled mandibular positioner for conveniently and precisely positioning the mandible during a sleep center or in-hospital study of patients who are candidates for mandibular positioner therapy. The remote-controlled mandibular positioner is used during sleep to perform a therapeutic titration study during full polysomnographic monitoring to determine the mandible position effective in treating obstructive sleep apnea. During the titration study, the mandible is advanced by a technician using the remote-controlled mandibular positioner until all apneas and hypopneas are eliminated. The titration study determines whether a mandibular positioner will be effective in treating a particular patient, and if so, the degree of mandibular ventral displacement required for effective treatment of obstructive sleep apnea.

Claims

1. A method for determining mandibular displacement effective in treating obstructive sleep apnea in a sleeping patient, comprising:

providing the patient with a remotely-controlled adjustable mandibular displacement device;

detecting evidence of obstruction of the sleeping patient'"'"'s airway; and

displacing the sleeping patient'"'"'s mandible while the patient is asleep with a remote unit which sends a signal to a first unit which relays a signal to the remotely-controlled adjustable mandibular displacement device until the evidence of obstruction of the sleeping patient'"'"'s airway is reduced below a predetermined value or eliminated.

2. The method of claim 1 wherein the detecting step further comprises:

detecting respiratory variation, apnea and hypoventilation.

3. The method of claim 1 wherein the detecting step comprises:

monitoring oxygen saturation, nasal airflow or snoring sound.

4. The method of claim 1 wherein the detecting step comprises:

monitoring supraglottic pressure and respiratory airflow.

5. The method of claim 1 wherein the detecting step comprises:

monitoring pressure, airflow, sound, oxygen saturation and body position.

6. The method of claim 1 further comprising:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the patient'"'"'s airway.

7. The method of claim 1 further comprising:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the sleeping patient'"'"'s airway when the sleeping patient is in a non-rapid eye movement sleep state, in a rapid eye movement sleep state, in a supine position, and in a lateral decubitus posture.

8. The method of claim 1 further comprising:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the sleeping patient'"'"'s airway when the sleeping patient is in a non-rapid eye movement sleep state or in a rapid eye movement sleep state.

9. The method of claim 8 wherein the recording step further comprises:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the sleeping patient'"'"'s airway when the sleeping patient is on their side or in a lateral decubitus posture.

10. A method for determining mandibular displacement effective in treating obstructive sleep apnea in a sleeping patient, comprising the steps of:

(a) providing the patient with a remotely-controlled adjustable mandibular displacement device;

(b) detecting evidence of obstruction of the sleeping patient'"'"'s airway;

(c) displacing the sleeping patient'"'"'s mandible ventrally while the patient is asleep with a remote unit which sends a signal to a first unit which relays a signal to the remotely-controlled adjustable mandibular displacement device; and

(d) repeating steps (b) and (c) until the evidence of obstruction of the sleeping patient'"'"'s airway is reduced below a predetermined value or eliminated.

11. The method of claim 10 wherein step (a) comprises:

filling an upper and a lower dental tray with molding material;

inserting the upper and lower dental trays into the patient'"'"'s mouth while the patient is awake until the molding material sets to form an upper dental appliance and a lower dental appliance;

attaching an actuator to the lower dental appliance; and

repositioning the upper and the lower dental appliances in the patient'"'"'s mouth while the patient is awake.

12. The method of claim 11 further comprising:

attaching the upper and the lower dental appliances together at a position effective in eliminating the evidence of obstruction of the sleeping patient'"'"'s airway.

13. The method of claim 12 further comprising:

forming a mandibular positioner for the patient.

14. The method of claim 10 wherein step (b) comprises:

monitoring changes in airflow, snoring and supraglottic pressure.

15. The method of claim 10 wherein step (c) comprises:

protruding the patient'"'"'s mandible a predetermined distance if evidence of obstruction of the patient'"'"'s airway is detected.

16. The method of claim 10 wherein step (c) comprises:

protruding the patient'"'"'s mandible a predetermined distance at a predetermined velocity if evidence of obstruction of the sleeping patient'"'"'s airway is detected.

17. The method of claim 16 wherein the predetermined distance is in the range of 0.25 to 2 millimeters.

18. The method of claim 16 wherein the predetermined velocity is in the range of 0.1 to 2 millimeters/second.

19. The method of claim 10 wherein when step (d) is performed step (b) is performed for a duration of about 1 minute.

20. The method of claim 10 further comprising:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the sleeping patient'"'"'s airway when the sleeping patient is in a supine position.

21. The method of claim 10 further comprising:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the sleeping patient'"'"'s airway when the sleeping patient is in a lateral decubitus posture.

22. The method of claim 10 further comprising:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the sleeping patient'"'"'s airway when the sleeping patient is in a non-rapid eye movement sleep state.

23. The method of claim 10 further comprising:

recording the amount of mandibular displacement that is effective in reducing or eliminating the evidence of obstruction of the sleeping patient'"'"'s airway when the sleeping patient is in a rapid eye movement sleep state.

24. A system for determining mandibular displacement effective in treating obstructive sleep apnea in a sleeping patient, comprising:

an adjustable mandibular displacement device;

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

a remote control system used to displace the adjustable mandibular displacement device while the patient is asleep, the remote control system comprising a first unit which sends signals to protrude the adjustable mandibular displacement device; and

a remote unit which sends signals to the first unit to protrude the adjustable mandibular displacement device.

25. The system of claim 24 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.

26. The system of claim 24 wherein the control system comprises:

a first unit which sends signals to protrude the adjustable mandibular displacement device; and

a remote unit which sends signals to the first unit to protrude the adjustable mandibular displacement device.

27. The system of claim 24 wherein the remote unit is a personal computer.

28. The system of claim 24 wherein the remote unit is a personal computer with a mandibular displacement device controller.

29. The system of claim 24 wherein the first unit has mandibular displacement device controller circuitry and logic which protrudes the adjustable mandibular displacement device.

30. The system of claim 29 wherein the first unit comprises:

a display which displays the current location and step increment of the adjustable mandibular displacement device;

a first input device which displaces the adjustable mandibular displacement device; and

a second input device which adjusts the step increment.

31. The system of claim 30 wherein the remote unit comprises:

a display which displays the current location and step increment of the adjustable mandibular displacement device;

a first input device which sends signals to the first input device of the first unit; and

a second input device which sends signals to the second input device of the first unit.