Mechanical ventilation in the presence of sleep disordered breathing

• US 8,011,365 B2
• Filed: 12/24/2004
• Issued: 09/06/2011
• Est. Priority Date: 12/29/2003
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Richards, Glenn, Buckley, Mark David, Douglas, Robert, Schindhelm, Klaus Henry, Ujhazy, Anthony John
• Primary Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US10/596,860
• Publication Number:
  US 20070215146A1
• Time in Patent Office: 2,447 Days
• Field of Search: 128/204.18, 12820421-20423, 128/204.26
• US Class Current: 128/204.23
• 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: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• 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 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/15 Detection of leaks

Abstract

A method for controlling operation of a CPAP apparatus. The apparatus has a blower (2), a patient interface (6), an air delivery conduit (8) for delivering air from the blower (2) to the patient interface (6), a sensor (4p) for determining the pressure in the patient interface (6), and a control mechanism (15) that causes air to be delivered at a desired pressure to the patient interface (6) and that detects transitions between inhalation and exhalation of a respiratory cycle of a patient in order to synchronise the blower output with the patient'"'"'s efforts. In one form the CPAP apparatus provides pressure in accordance with a bi-level waveform with at least one characterising parameter of the waveform being automatically adjusted in accordance with indications of sleep disordered breathing. The indications of sleep disordered breathing can be one or more of snoring, apnea, hypopnea, and flow limitation.

Claims

1. In a CPAP apparatus having (i) a blower, (ii) a patient interface, (iii) an air delivery conduit for delivering air from the blower to the patient interface, (iv) a sensor adapted to generate a first signal determined from pressure in the patient interface, (v) a sensor adapted to generate a second signal determined from flow of air to the patient, (vi) a synchrony module programmed to determine transitions between inspiration and expiration of the patient'"'"'s breathing cycle from at least one of said sensors, and (vii) a control mechanism programmed to provide a supply of air from said blower to the patient interface at positive pressure in accordance with a pressure-time template, a method of controlling the blower operation comprising the steps of:

automatically determining from at least one of said first and second signals the presence of a first sleep disordered breathing event;

said first sleep disordered breathing event being categorized as an apnea, a hypopnea, or a snore; and

automatically determining from at least one of said first and second signals whether there is present a second sleep disordered breathing event;

said second sleep disordered breathing event characterized by flow flattening, where said first and second events are determined from different characteristics of said first and second signals,

automatically determining a first treatment pressure in accordance with the first sleep disordered breathing event and a second treatment pressure in accordance with the second sleep disordered breathing event,

setting a pressure parameter of the pressure-time template to the first treatment pressure during the expiration phase of the patient'"'"'s breathing cycle and setting a pressure parameter of the pressure-time template to the second treatment pressure during the inspiratory phase of the patient'"'"'s breathing cycle, and

controlling the blower to deliver a supply of air at positive pressure to the patient interface in accordance with the template and in synchrony with the patient'"'"'s breathing cycles as determined by the synchrony module.

2. A method in accordance with claim 1 in which said template is one of a square wave and a shark-fin wave.

3. A method in accordance with claim 1 in which the first treatment pressure is an EPAP and the second treatment pressure is an IPAP.

4. A method in accordance with claim 1 in which the pressure-time template has a maximum allowable swing between the first treatment pressure and the second treatment pressure.

5. A method in accordance with claim 1 wherein the first treatment pressure is decreased in the absence of an indication of apnea, hypopnea and snoring.

6. A method in accordance with claim 1 wherein the second treatment pressure is decreased in the absence of an indication of flow flattening and snoring.

7. A method in accordance with claim 1 wherein said pressure-time template is stored in look-up tables or arrays.

8. An apparatus for treatment of sleep disordered breathing comprising:

a blower for providing to a patient a supply of air at a treatment pressure in phase with the patient'"'"'s respiratory breathing cycle, the respiratory breathing cycle including an expiratory phase and an inspiratory phase;

a patient interface;

an air delivery conduit for delivering air from the blower to the patient interface;

a first sensor adapted to generate a first signal determined from the pressure in the patient interface;

a second sensor adapted to generate a second signal determined from the flow of air to the patient through the patient interface;

a synchrony module for detecting transitions between inspiration and expiration of the patient'"'"'s breathing cycle from at least one of said sensors; and

a controller programmed to;

(1) receive said first and second signals and in response thereto detect the presence of first and second sleep disordered breathing events, the first event being at least one of an apnea, a hypopnea, or a snore and the second event being a different flow limitation; and

(2) set a first pressure as a function of the occurrence of the first event and set a second pressure as a function of the occurrence of the second event, the first pressure being used to determine the treatment pressure provided during the expiratory phase of the breathing cycle and the second pressure being used to determine the treatment pressure provided during the inspiratory phase of the breathing cycle.

9. The apparatus according to claim 8 wherein the second event is flow flattening.

10. The apparatus according to claim 8 wherein the first pressure is an EPAP or EEP pressure.

11. The apparatus according to claim 8 wherein the second pressure is an IPAP pressure.

12. The apparatus according to claim 8 wherein there is a predetermined maximum pressure difference between the first pressure and the second pressure.

13. The apparatus according to claim 8 wherein the controller is further programmed to provide the supply of air at positive pressure in accordance with a pressure-time template.

14. The apparatus according to claim 13 wherein the pressure-time template is a square wave.

15. The apparatus according to claim 13 wherein the pressure-time template is a shark-fin wave.

16. The apparatus according to claim 13 wherein the pressure-time template is stored in look-up tables or arrays.

17. The apparatus according to claim 8 wherein the controller is further programmed to decrease the first pressure in the absence of the detection of first events.

18. The apparatus according to claim 8 wherein the controller is further programmed to decrease the second pressure in the absence of the detection of second events.

19. In a CPAP apparatus having (i) a blower, (ii) a patient interface, (iii) an air delivery conduit for delivering air from the blower to the patient interface, (iv) at least one sensor adapted to sense pressure or flow and to generate at least one signal from said determined pressure or flow, and (v) a controller that determines transitions between inspiration and expiration of the patient'"'"'s breathing cycle, and that causes said blower to provide a supply of air to the patient interface at positive pressure in accordance with a pressure-time template, a method of controlling the blower operation comprising the steps of:

determining the presence of a first sleep disordered breathing event from said at least one signal;

said first sleep disordered breathing event being in the group consisting of an apnea, a hypopnea, or a snore; and

the presence of a second sleep disordered breathing event from said at least one signal;

said second sleep disordered breathing event being characterized by flow flattening;

where said first and second events are determined from different characteristics of said at least one signal,

setting a first pressure parameter of the pressure-time template for the expiration phase of the patient'"'"'s breathing cycle in accordance with the first event and setting a second pressure parameter of the pressure-time template for the inspiratory phase of the patient'"'"'s breathing cycle in accordance with the second event, and

controlling the blower to deliver a supply of air at positive pressure to the patient interface in accordance with the template and in synchrony with the determined transitions between inspiration and expiration of the patient'"'"'s breathing cycle.

20. A method in accordance with claim 19 in which said template is one of a square wave and a shark-fin wave.

21. A method in accordance with claim 19 in which the first pressure parameter is an EPAP and the second pressure parameter is an IPAP.

22. A method in accordance with claim 19 in which the pressure-time template has a maximum allowable swing between the minimum and maximum values of pressure that is delivered to the patient interface by the blower.

23. A method in accordance with claim 19 wherein the first pressure parameter is decreased in the absence of an indication of apnea, hypopnea and snoring.

24. A method in accordance with claim 19 wherein the second pressure parameter is decreased in the absence of an indication of flow flattening and snoring.

25. A method in accordance with claim 19 wherein said pressure-time template is stored in look-up tables or arrays.

26. An apparatus adapted for treatment of sleep disordered breathing comprising:

a blower for providing to a patient a supply of air at a treatment pressure in phase with the patient'"'"'s respiratory breathing cycle, the respiratory breathing cycle including an expiratory phase and an inspiratory phase;

a patient interface,

an air delivery conduit for delivering air from the blower to the patient interface,

at least one sensor for sensing pressure in the patient interface or flow of air to the patient and to generate at least one signal determined from said sensed pressure or flow, and

a controller for

determining transitions between inspiration and expiration of the patient'"'"'s breathing cycle;

determining the presence first and second sleep disordered breathing events based on sensed pressure or flow, the first and second events being different indications of sleep disordered breathing and being based on different characteristics of said at least one signal;

said first event being at least one of an apnea, a hypopnea, or a snore and said second event being a flow limitation, and

setting a first pressure as a function of the occurrence of one of said events and setting a second pressure as a function of the occurrence of the other of said events, the first pressure being used to determine the treatment pressure provided during the expiratory phase of the patient'"'"'s breathing cycle and the second pressure being used to determine the treatment pressure provided during the inspiratory phase of the patient'"'"'s breathing cycle.

27. The apparatus according to claim 26 wherein the second event is flow limitation.

28. The apparatus according to claim 26 wherein the first pressure is an EPAP or EEP pressure.

29. The apparatus according to claim 26 wherein the second pressure is an IPAP pressure.

30. The apparatus according to claim 26 wherein there is a predetermined maximum pressure difference between the first pressure and the second pressure.

31. The apparatus according to claim 26 wherein the controller causes the blower to provide the supply of air at positive pressure in accordance with a pressure-time template.

32. The apparatus according to claim 31 wherein the pressure-time template is a square wave.

33. The apparatus according to claim 31 wherein the pressure-time template is a shark-fin wave.

34. The apparatus according to claim 31 wherein the pressure-time template is stored in look-up tables or arrays.

35. The apparatus according to claim 26 wherein the controller further causes the blower to decrease the first pressure in the absence of the detection of first events.

36. The apparatus according to claim 26 wherein the controller further causes the blower to decrease the second pressure in the absence of the detection of second events.