Gas supply device for sleep apnea

• US 6,761,168 B1
• Filed: 11/08/2001
• Issued: 07/13/2004
• Est. Priority Date: 05/21/1999
• Status: Expired due to Term

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Mallinckrodt Developpement France
• Inventors: Lanoir, Véronique Griller, Nicolazzi, Pascal, Nadjafizadeh, Hossein
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/913,296
• Time in Patent Office: 978 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit

Abstract

Methods and apparatus for controlling air supplied under pressure to a patient suffering from sleep disorders such as apnoea. Controlled pressurized air is supplied to the patient'"'"'s upper anatomical airways by the apparatus according to the methods of the present invention. The apparatus measures the air flow and pressure to the airway, and determines whether to increase or decrease the pressure based on a determination of several factors, such as the occurrence of an obstructive or central apnoea, hyperventilation, air leakage and acoustical vibrations. Occurrences of apnoeas may be stored by the apparatus and read by a clinician at a later date.

Claims

1. A method of controlling an apparatus for supplying air pressure delivered to a patient, comprising:

providing a flow of air at a maintenance pressure to an airway of a patient;

measuring the flow of air to the patient;

detecting the presence of an apnoea in the flow of air to the patient;

detecting oscillations of the measured air flow to the patient;

determining whether an amplitude of the detected oscillations is greater than a first central apnoea threshold;

determining whether an amplitude of the detected oscillations is less than the first central apnoea threshold;

identifying the occurrence of a central apnoea when the amplitudes of the detected oscillations are successively greater than and then less than the first central apnoea threshold;

summing each occurrence of the central apnoeas identified during a ventilation cycle of air flow to the patient;

determining whether the sum of the occurrence of central apnoeas is less than or equal to a second central apnoea threshold during the ventilation cycle;

determining whether the ventilation cycle is a normal cycle; and

increasing the pressure of the air flow to the patient above the maintenance pressure when the ventilation cycle is determined to be a normal cycle, the presence of an apnoea is detected and the sum of the occurrence of central apnoeas is less than or equal to the second central apnoea threshold.

2. The method according to claim 1, further comprising:

measuring the pressure of the air flow to the patient;

setting a high pressure time counter to zero when the pressure of the air flow to the patient is less than a high pressure threshold;

incrementing the high pressure time counter when the pressure of the air flow to the patient is not less than the high pressure threshold; and

reducing the pressure of the air flow to the patient to a safety pressure value when the value of the high pressure time counter is greater than a maximum high pressure time threshold.

3. The method according to claim 2, further comprising setting the high pressure threshold to between ten mbar and twenty-five mbar, setting the maximum high pressure time threshold to between one minute and one hundred minutes, and setting safety pressure value to about eight mbar.

4. The method according to claim 1, wherein determining whether a ventilation cycle of air flow to the patient is a normal cycle includes calculating a mean amplitude of the flow air to the patient of during the ventilation cycle and includes designating the ventilation cycle as not a normal cycle when the mean amplitude is greater than a first hyperventilation factor.

5. The method according to claim 1, further comprising measuring a leakage of air flow to the patient during the ventilation cycle, and maintaining the level of pressure of the air flow to the patient when the measured air leakage is greater than a leakage level threshold.

6. The method according to claim 5, further comprising setting the leakage level threshold to substantially equal to an additive leakage value summed with a leakage coefficient multiplied by the measured air flow to the patient.

7. The method according to claim 6, further comprising setting the additive leakage coefficient between zero liters/minute and one hundred liters/minute, and setting the leakage coefficient between zero liters/minute-mbar and ten liters/minute-mbar.

8. The method according to claim 1, further comprising analyzing the detected oscillations so as to identify acoustic vibrations within an acoustic frequency range, and increasing the pressure of the air flow to the patient when acoustic vibrations are identified.

9. The method according to claim 8, further comprising setting the acoustic frequency range between about thirty hertz and about three hundred hertz.

10. The method according to claim 1, further comprising storing a chronology of each detected presence of an apnoea in the flow of air to the patients, and reading the stored chronology.

11. A method for supplying air under pressure to a patient, comprising:

providing a flow of air at a pressure to an airway of a patient;

measuring the flow of air to the patient;

measuring the pressure of the air flow to the patient;

detecting the presence of an apnoea in the flow of air to the patient;

detecting oscillations of the measured air flow to the patient;

determining whether an amplitude of the detected oscillations is greater than a first central apnoea threshold;

determining whether an amplitude of the detected oscillations is less than the first central apnoea threshold;

identifying the occurrence of a central apnoea when the amplitudes of the detected oscillations are successively greater than and then less than the first central apnoea threshold;

summing each occurrence of the central apnoeas identified during a ventilation cycle of air flow to the patient;

determining whether the sum of the occurrence of central apnoeas is less than or equal to a second central apnoea threshold during the ventilation cycle;

determining whether the ventilation cycle is a normal cycle, including calculating a mean amplitude of the flow air to the patient of during the ventilation cycle and designating the ventilation cycle as not a normal cycle when the mean amplitude is greater than a first hyperventilation factor;

setting a high pressure time counter to zero when the pressure of the air flow to the patient is less than a high pressure threshold;

incrementing the high pressure time counter when the pressure of the air flow to the patient is not less than the high pressure threshold;

measuring a leakage of air flow to the patient during the ventilation cycle;

increasing the pressure of the air flow to the patient when the ventilation cycle is determined to be a normal cycle, the presence of an apnoea is detected, the sum of the occurrence of central apnoeas is less than or equal to the second central apnoea threshold and the measured air leakage is not greater than a leakage level threshold; and

reducing the pressure of the air flow to the patient to a safety pressure value when the value of the high pressure time counter is greater than a maximum high pressure time threshold.

12. The method according to claim 11, further comprising analyzing the detected oscillations so as to identify acoustic vibrations within an acoustic frequency range, and increasing the pressure of the air flow to the patient when acoustic vibrations are identified.

13. An apparatus for supplying air pressure delivered to a patient, comprising:

means for providing a flow of air at a maintenance pressure to an airway of a patient;

means for measuring the flow of air to the patient;

means for detecting the presence of an apnoea in the flow of air to the patient;

means for detecting oscillations of the measured air flow to the patient;

means for determining whether an amplitude of the detected oscillations is greater than a first central apnoea threshold;

means for determining whether an amplitude of the detected oscillations is less than the first central apnoea threshold;

means for identifying the occurrence of a central apnoea when the amplitudes of the detected oscillations are successively greater than and then less than the first central apnoea threshold;

means for summing each occurrence of the central apnoeas identified during a ventilation cycle of air flow to the patient;

means for determining whether the sum of the occurrence of central apnoeas is less than or equal to a second central apnoea threshold during the ventilation cycle;

means for determining whether the ventilation cycle is a normal cycle; and

means for increasing the pressure of the air flow to the patient above the maintenance pressure when the ventilation cycle is determined to be a normal cycle, the presence of an apnoea is detected and the sum of the occurrence of central apnoeas is less than or equal to the second central apnoea threshold.

14. The apparatus of claim 13, wherein the means for determining whether a ventilation cycle of air flow to the patient is a normal cycle includes means for calculating a mean amplitude of the flow air to the patient of during the ventilation cycle, and means for designating the ventilation cycle as not a normal cycle when the mean amplitude is greater than a first hyperventilation factor.

15. The apparatus of claim 13, further comprising:

means for measuring the pressure of the air flow to the patient;

means for setting a high pressure time counter to zero when the pressure of the air flow to the patient is less than a high pressure threshold;

means for incrementing the high pressure time counter when the pressure of the air flow to the patient is not less than the high pressure threshold; and

means for reducing the pressure of the air flow to the patient to a safety pressure value when the value of the high pressure time counter is greater than a maximum high pressure time threshold.

16. The apparatus of claim 13, further comprising means for measuring a leakage of air flow to the patient during the ventilation cycle, and means for maintaining the pressure of the air flow to the patient when the measured air leakage is greater than a leakage level threshold.

17. The apparatus of claim 16, further comprising means for setting the leakage level threshold to substantially equal to an additive leakage value summed with a leakage coefficient multiplied by the measured air flow to the patient.

18. The apparatus of claim 13, further comprising means for analyzing the detected oscillations within an acoustic frequency range so as to identify acoustic vibrations, and means for increasing the pressure of the air flow to the patient when acoustic vibrations are identified.