Method and apparatus for providing positive airway pressure to a patient

• US 6,105,575 A
• Filed: 03/12/1998
• Issued: 08/22/2000
• Est. Priority Date: 06/03/1994
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: Respironics Incorporated
• Inventors: Estes, Mark C., Mechlenburg, Douglas M., Fiore, John H.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): WEISS JR, JOSEPH
• Application Number:
  US09/041,195
• Time in Patent Office: 894 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26
• US Class Current: 128/204.23
• 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 16/204 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 2016/0039 in the inspiratory circuit

Abstract

A system including methods and apparatus for treatment of a medical disorder such as obstructive sleep apnea or congestive heart failure. The system involves applying separate and independent gains to flow rates of pressurized gas delivered to a patient during inspiratory and expiratory phases of a respiratory cycle to deliver the pressurized gas in proportion to the respective gains during inspiration and expiration. A base pressure may be applied in addition to the gain-modified pressures and an elevated pressure profile may be employed to assist or control inspiration. The system may be fully automated responsive to feedback provided by a flow sensor that determines the estimated patient flow rate. A leak computer can be included to instantaneously calculate gas leakage from the system. The system may be utilized in connection with conventional continuous positive airway pressure (bi-level PAP) equipment to effect various beneficial treatment applications.

Claims

1. An apparatus for delivering pressurized breathing gas to an airway of a patient, said apparatus comprising:

a gas flow generator;

a patient interface adapted to couple said gas flow generator to an airway of such a patient;

a sensor adapted to detect a fluid characteristic associated with a flow of gas within said patient interface and to transmit a signal corresponding to said characteristic;

a pressure controller associated with at least one of said gas flow generator and said patient interface to control a pressure of breathing gas provided by said gas flow generator;

control means, receiving said signal from said sensor, for controlling said pressure controller so as to cause said breathing gas to be delivered to such a patient at a minimally sufficient pressure during, at least a portion of a breathing cycle to perform, at least one of the following functions at any given moment;

(1) reduce cardiac preload and afterload, wherein said minimally sufficient pressure is a summation of a pressure needed to reduce cardiac preload and afterload in an absence of respiratory loading and a pressure needed to overcome an impact of respiratory loading on cardiac preload and afterload; and

(2) prevent airway collapse, wherein said minimally sufficient pressure is a summation of a pressure needed to prevent airway collapse and a pressure needed to overcome respiratory effort; and

a first selector unit operatively connected to said control means to selectively establish a first gain, said control means controlling said pressure controller so as to deliver said breathing gas at said minimally sufficient pressure during at least a portion of said breathing cycle based on said first gain and said signal from said sensor.

2. The apparatus of claim 1, wherein said fluid characteristic is one of a rate of said flow of gas within said patient interface and a volume of gas to be exhaled, wherein said volume of gas to be exhaled corresponds to a difference between a current volume of gas in such a patient and a volume of gas within such a patient at rest.

3. The apparatus of claim 1, further comprising a second selector unit operatively unit operatively connected to said control means to selectively establish a second gain, said control means applying said first gain to a first signal output said sensor, said first signal corresponding to a fluid characteristic indicative of inspiration, and applying said second gain to a second signal output by said sensor, said second signal corresponding to a fluid characteristic indicative of expiration.

4. The apparatus of claim 3, further comprising a base pressure controller operatively coupled to said control means to selectively establish a base pressure to be provided by said pressure controller, said base pressure being provided by said pressure controller in addition to said gas pressure provided based on said first gain and said first signal during inspiration and based on said second gain and said second signal during expiration, said base pressure being substantially equivalent to at least one of:

(1) said pressure needed to reduce cardiac preload and afterload in the absence of cardiac loading, wherein said pressure needed to overcome respiratory loading is proportional to a respective first and second gain, and

(2) said pressure needed to prevent airway collapse, wherein said pressure needed to overcome respiratory effort is proportional to a respective first and second gain.

5. The apparatus of claim 4, further comprising means for adjusting at least one of said first gain, said second gain, and said base pressure responsive to signals received from said sensor.

6. The apparatus of claim 3, wherein said control means controls said pressure controller so as to prevent oscillations in said fluid characteristic during expiration.

7. The apparatus of claim 6, wherein said control means controls said pressure controller to prevent oscillations by causing said pressure controller to provide a pressure to such a patient during expiration that is a greater of (1) a first minimally sufficient pressure that is determined by applying said second gain to said second signal output by said sensor, and (2) a second minimally sufficient pressure that corresponds to a current pressure being provided to such a patient.

8. The apparatus of claim 6, wherein said control means controls said pressure controller to prevent oscillations by causing said pressure controller to provide an expiration pressure to such a patient that is determined based on a volume of gas to be exhaled and said second gain, wherein said volume of gas to be exhaled corresponds to a difference between a current volume of gas in such a patient and a volume of gas in such a patient at rest.

9. The apparatus of claim 8, wherein said expiration pressure during an initial portion of a patient'"'"'s expiratory phase is determined based on a dampening factor.

10. The apparatus of claim 1, further comprising means operatively connected to said control means for selectively establishing a pressure profile to be provided by said pressure controller during a predetermined portion of a respiratory cycle.

11. The apparatus of claim 10, further comprising means for adjusting at least one of said first gain, said second gain, and said pressure profile responsive to signals received from said sensor.

12. The apparatus of claim 1, wherein said control means controls said pressure controller to provide a continuous positive pressure during an inspiratory phase of such a patient'"'"'s breathing cycle and to provide said minimally sufficient pressure based on said first gain and said signal from said sensor during an expiratory phase of said patient'"'"'s breathing cycle.

13. The apparatus of claim 1, wherein said control means controls said pressure controller to provide a positive pressure at a first level during an inspiratory phase of such a patient'"'"'s breathing cycle and to provide a second pressure during an expiratory phase of said breathing cycle, wherein said second pressure has a second level that is lower than said first level and is further reduced by an amount based on said first gain and said signal from said sensor.

14. The apparatus of claim 1, further comprising means, upon actuation, for increasing said pressure of said gas being provided to such a patient from a first minimum pressure to said minimally sufficient pressure over a period of time.

15. The apparatus of claim 1, further comprising means for adjusting said first gain.

16. The apparatus of claim 1, wherein said first selector unit automatically determines said first gain based on said signal from said sensor.

17. The apparatus of claim 16, further comprising an alarm actuated responsive to said automatically determined first gain falling outside a predetermined range of values.

18. The apparatus of claim 16, further comprising means for limiting a value for said automatically determined first gain.

19. The apparatus of claim 18, further comprising means for altering limits on said value for said automatically determined first gain over a predetermined period of time.

20. The apparatus of claim 16, further comprising means for preventing said automatically determined first gain from changing by more than a predetermined amount over a predetermined period of time.

21. A proportional positive airway pressure apparatus for delivering pressurized breathing gas to an airway of a patient, said apparatus comprising:

a gas flow generator;

a patient interface adapted to couple said gas flow generator to an airway of a patient;

a sensor adapted to detect at least one physiological condition of such a patient, wherein said physiological condition is suitable for use to differentiate between an expiratory phase and an inspiratory phase of a breathing cycle of such a patient and to output a signal indicative thereof;

a pressure controller associated with at least one of said gas flow generator and said patient interface to control a pressure of said breathing gas provided by said gas flow generator;

control means for controlling said pressure controller so as to cause said breathing gas to be delivered to such a patient at a first pressure level during at least a portion of said inspiratory phase of said breathing cycle and in accordance with a predetermined pressure profile during said expiratory phase of said breathing cycle, wherein a shape of said predetermined pressure profile is set independent of any monitored respiratory characteristics of such a patient.

22. An apparatus of claim 21, further comprising means for setting at least one of a magnitude and a duration of said pressure profile.

23. A method of providing pressured breathing gas to an airway of a patient, said method comprising the steps of:

supplying gas to an airway of such a patient from a source of gas via a patient interface;

determining a fluid characteristic associated with a flow of gas within said patient interface and outputting a fluid characteristic signal indicative thereof;

establishing a first gain to be applied to said fluid characteristic signal; and

controlling said supply of gas to such a patient during at least a portion of a breathing cycle based on said fluid characteristic signal and said first gain so as to deliver said gas to such a patient at a minimally sufficient pressure to perform at least one of the following functions at any given moment during at least a portion of a breathing cycle;

(1) reduce cardiac preload and afterload, wherein said minimally sufficient pressure is a summation of a pressure needed to reduce cardiac preload and afterload in an absence of respiratory loading and a pressure needed to overcome an impact of respiratory loading on cardiac preload and afterload; and

(2) prevent airway collapse, wherein said minimally sufficient pressure is a summation of a pressure needed to prevent airway collapse and pressure needed to overcome respiratory effort.

24. The method of claim 23, wherein said fluid characteristic determined in said determining step is one of (1) a rate of flow of said gas within said patient interface and (2) a volume of gas to be exhaled, wherein said volume of gas to be exhaled corresponds to a difference between a current volume of gas in such a patient and a volume of gas within such a patient at rest.

25. The method of claim 23, further comprising a step of establishing a second gain to be applied to said fluid characteristic signal, wherein said step of controlling said supply of gas to such a patient includes applying said first gain go a first fluid characteristic signal indicative of inspiration, and applying said second gain to a second fluid characteristic signal indicative of expiration.

26. The method of claim 25, further comprising a step of:

controlling said supply of gas so as to provide a base pressure of gas in addition to said pressure provided based on said first gain and said first fluid characteristic signal during inspiration and said pressure provided based on said second gain and said second fluid characteristic signal during expiration, said base pressure being substantially equivalent to at least one of;

(1) said pressure needed to reduce cardiac preload and afterload in the absence of cardiac loading, wherein said pressure needed to overcome respiratory loading is proportional to a respective first and second gain, and

(2) said pressure needed to prevent airway collapse, wherein said pressure needed to overcome respiratory effort is proportional to a respective first and second gain.

27. The method of claim 26, further comprising a step of adjusting at least one of said first gain, said second gain, and said base pressure responsive to signals received from said sensor.

28. The method of claim 25, wherein said controlling step includes controlling said pressure controller so as to prevent oscillations in said fluid characteristic during expiration.

29. The method of claim 28, wherein controlling said pressure controller so as to prevent oscillations includes providing a pressure to such a patient during expiration at one of (1) a first minimally sufficient pressure that is determined by applying said second gain to said second signal output by said sensor, and (2) a second minimally sufficient pressure that corresponds to a current pressure being provided to such a patient.

30. The method of claim 28, wherein controlling said pressure controller so as to prevent oscillations includes providing an expiration pressure to such a patient during expiration that is determined based on a volume of gas to be exhaled and said second gain, wherein said volume of gas to be exhaled corresponds to a difference between a current volume of gas in such a patient and a volume of gas in such a patient at rest.

31. The method of claim 28, wherein controlling said pressure controller so as to prevent oscillations includes determining said expiration pressure during an initial portion of said patient'"'"'s expiratory phase based on a dampening factor.

32. The method of claim 23, further comprising a step of selectively establishing a pressure profile to be provided to such a patient during a predetermined portion of a respiratory cycle.

33. The method of claim 32, further comprising at step of adjusting at least one of said first gain, said second gain, and said pressure profile responsive to said fluid characteristic signal.

34. The method of claim 23, wherein said controlling steps includes (1) providing a continuous positive pressure during an inspiratory phase of such a patient'"'"'s breathing cycle and (2) providing said minimally sufficient pressure based on said first gain and said signal from said sensor during an expiratory phase of such a patient'"'"'s breathing cycle.

35. The method of claim 23, wherein said controlling steps includes (1) providing a positive pressure at a first level during an inspiratory phase of such a patient'"'"'s breathing cycle and (2) providing a second pressure during an expiratory phase of a breathing cycle, wherein said second pressure has a second level that is lower than said first level and is further reduced by an amount based on said first gain and said signal from said sensor.

36. The method of claim 23, wherein said controlling steps includes increasing said pressure of said gas being provided to said patient from a first minimum pressure to said minimally sufficient pressure over a period of time.

37. The method of claim 23, further comprising a step of adjusting said first gain.

38. The method of claim 23, further comprising a step of automatically determining said first gain based on said signal from said sensor.

39. The method of claim 38, further comprising a step of generating an alarm responsive to said automatically determined first gain falling outside a predetermined range of values.

40. The method of claim 38, further comprising a step of limiting a value for said automatically determined first gain.

41. The method of claim 40, further comprising a step of altering limits on said value for said automatically determined first gain over a predetermined period of time.

42. The method of claim 38, further comprising a step of preventing said automatically determined first gain from changing by more than a predetermined amount over a predetermined period of time.

43. A method of delivering pressurized breathing gas to an airway of a patient, said method comprising the steps of:

providing a gas flow generator and a patient interface adapted to couple said gas flow generator to an airway of a patient;

detecting at least one physiological condition of such a patient, wherein said physiological condition is suitable for use to differentiate between an expiratory phase and an inspiratory phase of a breathing cycle of such a patient and outputting signals indicative thereof; and

controlling said gas flow to such a patient at a first pressure level during at least a portion of said inspiratory phase and in accordance with a predetermined pressure profile during said expiratory phase of said breathing cycle, wherein a shape of said predetermined pressure profile is set independent of any monitored respiratory characteristics of such a patient.

44. The method of claim 43, further comprising a step of setting at least one of a magnitude and a duration of said pressure profile.