Breathing gas delivery method and apparatus

• US 7,100,607 B2
• Filed: 05/27/2005
• Issued: 09/05/2006
• Est. Priority Date: 09/22/1989
• Status: Expired due to Fees

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Inventors: Zdrojkowski, Ronald J., Sanders, Mark, Estes, Mark
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US11/139,235
• Publication Number:
  US 20050224078A1
• Time in Patent Office: 466 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.22, 128/204.23, 128/204.24
• US Class Current: 128/204.18
• 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 16/026 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 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/205 used for exhalation control
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital

Abstract

An improved methodology and systems for delivery of breathing gas such as for the treatment of obstructive sleep apnea through application of alternating high and low level positive airway pressure within the airway of the patient with the high and low airway pressure being coordinated with the spontaneous respiration of the patient, and improved methods and apparatus for triggering and for leak management in such systems.

Claims

1. A method of treating obstructive sleep apnea comprising the steps of:

providing a pressure support system to a patient diagnosed as suffering from obstructive sleep apnea, wherein the pressure support system is adapted to generate a flow of gas;

communicating the flow of gas to an airway of a patient via a patient circuit connected to the pressure support system;

applying the flow of gas to an airway of such a patient during at least a portion of an inspiratory phase at a pressure sufficient to prevent airway obstruction; and

adjusting a pressure of the flow of gas in the patient'"'"'s airway to coordinate the application of a positive pressure to such a patient'"'"'s airway with an occurrence of alternating inspiratory and expiratory phases of such a patient'"'"'s respiration so as to provide the positive pressure in such a patient'"'"'s airway during a sequence of inspiratory and expiratory phases, and wherein the positive pressure during at least a portion of each expiratory phase is less than a magnitude of the positive pressure during at least a portion of an immediately preceding inspiratory phase.

2. The method as set forth in claim 1, wherein the positive pressure is applied to an airway of such a patient at an inspiratory positive airway pressure that is substantially constant during a majority of an inspiratory phase of such a patient'"'"'s breathing cycle.

3. The method as set forth in claim 1, wherein the positive pressure is applied to an airway of such a patient at an expiratory positive airway pressure that is substantially constant during a majority of an expiratory phase of such a patient'"'"'s breathing cycle.

4. The method as set forth in claim 1, further comprising exhausting gas from the patient circuit to ambient atmosphere using an exhaust port provided in the patient circuit proximate to the patient interface or provided in the patient interface.

5. The method as set forth in claim 1, further comprising identifying changes in such a patient'"'"'s respiratory state between inspiration and expiration by monitoring the flow of gas to detect a first parameter indicative of an instantaneous flow rate, processing the first parameter to provide a reference, and comparing the first parameter and the reference.

6. The method as set forth in claim 1, wherein processing the first parameter includes determining an average rate of the flow of gas as the reference.

7. The method as set forth in claim 1, further comprising determining a leak component of the flow of gas by determining a rate of the flow of gas, integrating the rate of the flow of for a selected plurality of patient respiratory cycles to determine a total respiratory gas volume for the selected plurality of patient respiratory cycles, and dividing the total respiratory gas volume for the selected plurality of patient respiratory cycles by a time duration associated with the selected plurality of patient respiratory cycles.

8. The method as set forth in claim 1, further comprising:

measuring a total flow of the flow of gas;

measuring a pressure P(t) of the flow of gas;

calculating, based on the total flow and the pressure, a characteristic K of a hypothetical orifice which represents an orifice through which all leakage of gas from the pressure support system occurs; and

determining a total instantaneous flow of the leakage of gas from the pressure support system based on the characteristic K of the hypothetical orifice.

9. The method as set forth in claim 1, wherein processing the first parameter includes determining an average rate of the flow of gas as the reference.

10. A method of treating obstructive sleep apnea comprising the steps of:

providing a pressure support system to a patient diagnosed as suffering from obstructive sleep apnea, wherein the pressure support system is adapted to generate a flow of gas;

communicating the flow of gas to an airway of such a patient;

adjusting a pressure of the flow of gas to coordinate with an occurrence of alternating inspiratory and expiratory phases of such a patient'"'"'s respiration so as to provide a positive pressure in such a patient'"'"'s airway during a sequence of inspiratory and expiratory phases, wherein the positive pressure during at least a portion of each expiratory phase is less than the positive pressure during at least a portion of an immediately preceding inspiratory phase, and wherein the positive pressure during at least a portion of the inspiratory phase is at a level sufficient to prevent an airway obstruction; and

identifying changes in such a patient'"'"'s respiratory state between inspiration and expiration by monitoring the flow of gas to detect a first parameter indicative of an instantaneous flow rate, processing the first parameter to provide a reference, and comparing the first parameter and the reference.

11. The method as set forth in claim 10, wherein the sequence consists of a single inspiratory phase followed by a single expiratory phase of such a patient'"'"'s respiration.

12. The method as set forth in claim 10, wherein the positive pressure is applied to an airway of such a patient at an inspiratory positive airway pressure that is substantially constant during a majority of an inspiratory phase of such a patient'"'"'s breathing cycle.

13. The method as set forth in claim 10, wherein the positive pressure is applied to an airway of such a patient at an expiratory positive airway pressure that is substantially constant during a majority of an expiratory phase of such a patient'"'"'s breathing cycle.

14. The method as set forth in claim 10, further comprising exhausting gas from the patient circuit to ambient atmosphere using an exhaust port provided in the patient circuit proximate to the patient interface or provided in the patient interface.

15. A method of treating obstructive sleep apnea comprising the steps of:

providing a pressure support system to a patient diagnosed as suffering from obstructive sleep apnea, wherein the pressure support system is adapted to generate a flow of gas;

communicating the flow of gas to an airway of such a patient;

adjusting a pressure of the flow of gas to coordinate with an occurrence of alternating inspiratory and expiratory phases of such a patient'"'"'s respiration so as to provide a positive pressure in such a patient'"'"'s airway during a sequence of inspiratory and expiratory phases, wherein the positive pressure during at least a portion of each expiratory phase is less than the positive pressure during at least a portion of an immediately preceding inspiratory phase, and wherein the positive pressure in such a patient'"'"'s airway during at least a portion of the inspiratory phase is at a level sufficient to prevent an airway obstruction; and

determining a leak component of the flow of gas by determining a rate of the flow of gas, integrating the rate of the flow of for a selected plurality of patient respiratory cycles to determine a total respiratory gas volume for the selected plurality of patient respiratory cycles, and dividing the total respiratory gas volume for the selected plurality of patient respiratory cycles by a time duration associated with the selected plurality of patient respiratory cycles.

16. The method as set forth in claim 15, wherein the positive pressure is applied to an airway of such a patient at an inspiratory positive airway pressure that is substantially constant during a majority of an inspiratory phase of such a patient'"'"'s breathing cycle.

17. The method as set forth in claim 15, wherein the positive pressure is applied to an airway of such a patient at an expiratory positive airway pressure that is substantially constant during a majority of an expiratory phase of such a patient'"'"'s breathing cycle.

18. The method as set forth in claim 15, further comprising exhausting gas from the patient circuit to ambient atmosphere using an exhaust port provided in the patient circuit proximate to the patient interface or provided in the patient interface.

19. A method of treating obstructive sleep apnea comprising the steps of:

providing a pressure support system to a patient diagnosed as suffering from obstructive sleep apnea, wherein the pressure support system is adapted to generate a flow of gas;

communicating the flow of gas to an airway of a patient;

adjusting a pressure of the flow of gas to coordinate with an occurrence of alternating inspiratory and expiratory phases of such a patient'"'"'s respiration so as to provide a positive pressure in such a patient'"'"'s airway during a sequence of inspiratory and expiratory phases, wherein the positive pressure during at least a portion of each expiratory phase is less the positive pressure during at least a portion of an immediately preceding inspiratory phase, and wherein the positive pressure in such a patient'"'"'s airway during at least a portion of the inspiratory phase is at a level sufficient to prevent an airway obstruction;

measuring a total flow of the flow of gas;

measuring a pressure P(t) of the flow of gas;

calculating, based on the total flow and the pressure, a characteristic K of a hypothetical orifice, which represents an orifice through which all leakage of gas from the pressure support system occurs; and

determining a total instantaneous flow of the leakage of gas from the pressure support system based on the characteristic K of the hypothetical orifice.

20. The method as set forth in claim 19, further comprising identifying changes in such a patient'"'"'s respiratory state between inspiration and expiration by monitoring patient breathing, determining a patient respiratory gas flow characteristic at selected time intervals to provide a plurality of gas flow characteristics displaced in time from one another based on the monitored breathing, identifying selected pairs of the respiratory gas flow characteristics from the plurality of gas flow characteristics displaced in time from one another, and comparing selected pairs of respiratory gas flow characteristics.

21. The method as set forth in claim 19, further comprising determining a predicted value of such a patient'"'"'s respiratory gas flow based on the monitored breathing, and wherein each selected pair of respiratory gas flow characteristics includes the predicted value of such a patient'"'"'s respiratory gas flow and such a patient'"'"'s actual respiratory gas flow rate.