Gas supply device for sleep apnea

• US 20050081854A1
• Filed: 10/18/2004
• Published: 04/21/2005
• Est. Priority Date: 05/21/1999
• Status: Active Grant

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Mallinckrodt Developpement France
• Inventors: Griller Lanoir, Veronique, Nicolazzi, Pascal, Nadjafizadeh, Hossein
• Granted Patent: US 7,370,650 B2
• Time in Patent Office: Days
• US Class Current: 128/204.230
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site

Abstract

An apparatus is provided for controlling air supplied under pressure to a patient suffering from sleep disorders such as apnoea. The apparatus measures and/or calculates the inspiratory air flow, volume and pressure to the airway. Controlled pressurized air is supplied to the patient'"'"'s upper anatomical airway, wherein the apparatus measures the air flow and pressure to the airway. The apparatus determines whether to increase or decrease the pressure to the patient'"'"'s airway based on a determination of one or more factors, such as the occurrence of hypopnoea, hyperventilation, obstructive or central apnoea, air leakage and acoustical vibrations. Occurrences of events representing a sleep problem may be stored by the apparatus and retrieved by a clinician at a later date.

Claims

1. A method for providing air to an airway of a patient, comprising:

supplying an inspiratory flow of air at a first pressure during a respiratory cycle of a patient;

determining whether the respiratory cycle is a valid respiratory cycle, including,

(a) measuring a rate of the inspiratory flow of air,

(b) measuring a volume of the inspiratory flow of air,

(c) measuring a duration of the inspiratory flow of air,

(d) measuring a duration of the respiratory cycle,

wherein the respiratory cycle is determined as valid when the rate of the inspiratory flow of air is greater than an inspiratory flow rate threshold, the volume of the inspiratory flow of air is greater than an inspiratory volume threshold, the duration of the inspiratory flow is within an inspiratory duration interval and the duration of the respiratory cycle is within a respiratory cycle duration interval;

incrementing a respiratory cycle counter when the respiratory cycle is determined as valid;

setting a problem appearance indicator, including,

(e) determining a sinusoidal curve equivalent to a curve of the inspiratory flow of air during the respiratory cycle,

(f) calculating a correlation criterion between the inspiratory flow rate curve and the equivalent sinusoidal curve,

(g) calculating a surface criterion proportional to the ratio of an area delimited by the inspiratory flow rate curve to an area delimited by the equivalent sinusoidal curve,

(h) setting the problem appearance indicator to a problem absence state or setting the problem appearance indicator to a problem appearance state when the calculated correlation criterion is less than a correlation criterion threshold or when the calculated surface criterion is less than a surface criterion threshold;

incrementing a problem appearance counter when the problem appearance indicator changes from the problem absence state to the problem appearance state; and

increasing the pressure of the inspiratory flow of air above the first pressure when the respiratory cycle has been determined to be a valid respiratory cycle, when the respiratory cycle counter is greater than a respiratory cycle threshold and when the problem appearance counter is greater than or equal to a problem appearance threshold.

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

measuring a pressure of the inspiratory flow of air;

setting a high pressure time counter to zero when the measured pressure is less than a high pressure threshold;

incrementing the high pressure time counter when the measured pressure is not less than the high pressure threshold; and

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

3. The method according to claim 1, further comprising measuring a leakage of inspiratory flow of air during the respiratory cycle, setting a leakage level threshold to substantially equal to an additive leakage value summed with a leakage coefficient multiplied by the rate of inspiratory flow of air and maintaining the first pressure of the inspiratory flow of air when the measured air leakage is greater than a leakage level threshold.

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

calculating a mean amplitude of the inspiratory flow of air; and

maintaining the inspiratory flow of air at the first pressure when the mean amplitude is greater tan a first hyperventilation factor.

5. The method accroding to claim 1, further comprising detecting oscillations of the inspiratory flow of air, analyzing the detected oscillations so as to identify acoustic vibrations, and increasing the pressure of the inspiratory flow of air when the acoustic vibrations are within an acoustic frequency range.

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

measuring a pressure of the inspiratory flow of air;

setting a high pressure time counter to zero when the measured pressure is less than a high pressure threshold;

incrementing the high pressure time counter when the measured pressure is not less than the high pressure threshold;

measuring a leakage of inspiratory flow of air during the respiratory cycle;

calculating a mean amplitude of the inspiratory flow of air;

analyzing oscillations of the inspiratory flow of air so as to identify acoustic vibrations; and

maintaining the inspiratory flow of air at the first pressure when the measured air leakage is greater than a leakage level threshold, maintaining the inspiratory flow of air at the first pressure when the mean amplitude is greater than a first hyperventilation factor, increasing the pressure of the inspiratory flow of air when the acoustic vibrations are within an acoustic frequency range and reducing the pressure of the inspiratory flow of air to a safety pressure value when the high pressure time counter is greater than a maximum high pressure time threshold.

7. A method for providing air to an airway of a patient, comprising:

supplying an inspiratory flow of air at a first pressure during a respiratory cycle of a patient;

detecting the presence of an apnoea during the respiratory cycle;

measuring a first amplitude of a first oscillation of the inspiratory flow of air;

measuring a second amplitude of a second oscillation of the inspiratory flow of air;

identifying the occurrence of a central apnoea when the first amplitude is greater than a first central apnoea threshold and when the second amplitude is less than the first central apnoea threshold;

determining a sum of the occurrence of central apnoeas during the respiratory cycle; and

increasing the pressure of the inspiratory flow of air above the first pressure when the presence of an apnoea is detected and the sum of the occurrence of central apnoeas is not greater than a second central apnoea threshold.

8. The method according to claim 7, further comprising:

measuring a pressure of the inspiratory flow of air;

setting a high pressure time counter to zero when the measured pressure is less than a high pressure threshold;

incrementing the high pressure time counter when the measured pressure is not less than the high pressure threshold; and

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

9. The method according to claim 7, further comprising measuring a leakage of inspiratory flow of air during the respiratory cycle, setting a leakage level threshold to substantially equal to an additive leakage value summed with a leakage coefficient multiplied by the rate of inspiratory flow of air and maintaining the first pressure of the inspiratory flow of air when the measured air leakage is greater than a leakage level threshold.

10. The method according to claim 7, further comprising:

calculating a mean amplitude of the inspiratory flow of air; and

maintaining the inspiratory flow of air at the first pressure when the mean amplitude is greater than a first hyperventilation factor.

11. The method according to claim 7, further comprising detecting oscillations of the inspiratory flow of air, analyzing the detected oscillations so as to identify acoustic vibrations, and increasing the pressure of the inspiratory flow of air when the acoustic vibrations are within an acoustic frequency range.

12. The method according to claim 7, further comprising:

measuring a pressure of the inspiratory flow of air;

setting a high pressure time counter to zero when the measured pressure is less than a high pressure threshold;

incrementing the high pressure time counter when the measured pressure is not less than the high pressure threshold;

measuring a leakage of inspiratory flow of air during the respiratory cycle;

calculating a mean amplitude of the inspiratory flow of air;

analyzing oscillations of the inspiratory flow of air so as to identify acoustic vibrations; and

maintaining the inspiratory flow of air at the first pressure when the measured air leakage is greater than a leakage level threshold, maintaining the inspiratory flow of air at the first pressure when the mean amplitude is greater than a first hyperventilation factor, increasing the pressure of the inspiratory flow of air when the acoustic vibrations are within an acoustic frequency range and reducing the pressure of the inspiratory flow of air to a safety pressure value when the high pressure time counter is greater than a maximum high pressure time threshold.

13. A method for providing air to an airway of a patient, comprising:

supplying an inspiratory flow of air at a pressure during a respiratory cycle of a patient;

determining a flow rate of the inspiratory flow of air during a current respiratory cycle;

determining an amplitude of the flow rate;

determining a mean amplitude of a flow rate of the inspiratory flow of air during a predetermined number of respiratory cycles;

incrementing a hypopnoea time counter when the amplitude of the flow rate during a current respiratory cycle is less than the mean amplitude of the flow rate multiplied by a hypopnoea factor;

increasing the pressure of the inspiratory flow of air by a first pressure increase value when the hypopnoea time counter is greater than or equal to a first hypopnoea time threshold;

after increasing the pressure of the inspiratory flow of air, reducing the pressure of the inspiratory flow of air by a first pressure reduction value when the pressure of the inspiratory flow of air is less than a comparative pressure value; and

after increasing the pressure of the inspiratory flow of air, reducing the pressure of the inspiratory flow of air by a second pressure reduction value when the pressure inspiratory flow of air is greater than or equal to the comparative pressure value.

14. The method according to claim 13, further comprising setting the second pressure reduction value greater than the first pressure reduction value.

15. The method according to claim 13, further comprising:

after increasing the pressure of the inspiratory flow of air by the first pressure increase value and after a first hypopnoea respiratory cycle threshold, increasing the pressure of the inspiratory flow of air by a second pressure increase value; and

after increasing the pressure of the inspiratory flow of air by the second pressure increase value and after a second hypopnoea respiratory cycle threshold, increasing the pressure of the inspiratory flow of air by a third pressure increase value.

16. The method according to claim 13, further comprising incrementing the hypopnoea time counter only when the mean amplitude of the flow rate of the inspiratory flow of air is less than a first hyperventilation threshold.

17. The method according to claim 13, further comprising:

measuring a pressure of the inspiratory flow of air;

setting a high pressure time counter to zero when the measured pressure is less than a high pressure threshold;

incrementing the high pressure time counter when the measured pressure is not less than the high pressure threshold; and

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

18. The method according to claim 13, further comprising measuring a leakage of inspiratory flow of air during the respiratory cycle, setting a leakage level threshold to substantially equal to an additive leakage value summed with a leakage coefficient multiplied by the rate of inspiratory flow of air and maintaining the first pressure of the inspiratory flow of air when the measured air leakage is greater than a leakage level threshold.

19. The method according to claim 13, further comprising measuring a leakage of inspiratory flow of air during the respiratory cycle, setting a leakage level threshold to substantially equal to an additive leakage value summed with a leakage coefficient multiplied by the rate of inspiratory flow of air and maintaining the first pressure of the inspiratory flow of air when the measured air leakage is greater than a leakage level threshold.

20. The method according to claim 13, further comprising:

measuring a pressure of the inspiratory flow of air;

setting a high pressure time counter to zero when the measured pressure is less than a high pressure threshold;

incrementing the high pressure time counter when the measured pressure is not less than the high pressure threshold;

measuring a leakage of inspiratory flow of air during the respiratory cycle;

analyzing oscillations of the inspiratory flow of air so as to identify acoustic vibrations; and

maintaining the inspiratory flow of air at the first pressure when the measured air leakage is greater than a leakage level threshold, increasing the pressure of the inspiratory flow of air when the acoustic vibrations are within an acoustic frequency range and reducing the pressure of the inspiratory flow of air to a safety pressure value when the high pressure time counter is greater than a maximum high pressure time threshold.