Method and apparatus for providing positive airway pressure to a patient

• US 6,609,517 B1
• Filed: 07/06/2000
• Issued: 08/26/2003
• 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., Fiore, John H., Machlenburg, Douglas M.
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/610,733
• Time in Patent Office: 1,146 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, comprising:

a gas flow generator;

a patient interface coupled to the gas flow generator to communicate a flow of breathing gas from the gas flow generator with an airway of a patient;

a sensor associated with the gas flow generator or the patient interface that detects a fluid characteristic associated with the flow of breathing gas within the patient interface and outputs a signal corresponding to the fluid characteristic;

a pressure controller associated with the gas flow generator or the patient interface to control a pressure of the flow of breathing gas delivered to a patient;

an input device; and

processing means, adapted to receive the signal output from the sensor, and an inspiratory gain and an expiratory gain from the input device, for producing a command signal, which is determined as;

(1) a product of the inspiratory gain and the fluid characteristic during at least a portion of an inspiratory phase of such a patient'"'"'s breathing cycle, and

(2) a product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient'"'"'s breathing cycle, and

wherein the processing means provides the command signal to the pressure controller so that a pressure of the breathing gas delivered to a patient varies during at least a portion of the inspiratory phase and during at least a portion of the expiratory phase with fluctuations of the fluid characteristic.

2. The apparatus of claim 1, wherein the patient interface includes a conduit, and wherein the pressure controller is a valve associated with the conduit that exhausts gas from the conduit to control the pressure of the flow of breathing gas delivered to the patient.

3. The apparatus of claim 1, wherein the sensor substantially continuously detects the fluid characteristic and substantially continuously outputs the signal to the processing means.

4. The apparatus of claim 1, wherein the processing means determines the command signal and provides it to the pressure controller substantially continuously.

5. The apparatus of claim 1, wherein the processing means determines the command signal according to:

(1) a pressure profile from a start of the inspiratory phase to a transition point occurring during the inspiratory phase, and

(2) based on the product of the inspiratory gain and the fluid characteristic from the transition point to the end of the inspiratory phase, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

6. The apparatus of claim 5, wherein the pressure profile corresponds to a time-based transition from a pressure at a start of the inspiratory phase to an inspiratory positive airway pressure (IPAP).

7. The apparatus of claim 5, wherein the signal from the sensor is indicative of the flow of breathing gas, and wherein the transition point is determined by the processing means based the flow of breathing gas.

8. The apparatus of claim 1, wherein the processing means determines the command signal according to:

(1) an inspiratory positive airway pressure (IPAP) from a start of the inspiratory phase to a transition point occurring during the inspiratory phase, and

(2) based on the product of the inspiratory gain and the fluid characteristic from the transition point to the end of the inspiratory phase, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

9. A method of delivering pressurized breathing gas to an airway of a patient, comprising:

generating a flow of breathing gas;

sensing a fluid characteristic associated with the flow of breathing gas and outputting a signal corresponding to the fluid characteristic;

selecting an inspiratory gain and an expiratory gain; and

controlling a pressure of the flow of breathing gas delivered to a patient based on;

(1) a product of the inspiratory gain and the fluid characteristic during at least a portion of an inspiratory phase of such a patient'"'"'s breathing cycle, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic, and

(2) a product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient'"'"'s breathing cycle, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

10. The method claim 9, wherein generating the flow of breathing gas includes carrying the flow of breathing gas to an airway of a patient via conduit, and wherein controlling the pressure of the flow of breathing gas includes exhausting gas from the conduit.

11. The method of claim 9, wherein sensing the fluid characteristic includes substantially continuously monitoring the fluid characteristic substantially continuously outputting the signal indicative of the fluid characteristic.

12. The method of claim 9, wherein controlling a pressure of the flow of breathing gas is done substantially continuously during a breathing cycle based on the output from the sensor, the inspiratory gain, and the expiratory gain.

13. The method of claim 9, wherein controlling a pressure of the flow of breathing gas delivered to a patient includes controlling the pressure of the flow of breathing gas according to:

(1) a pressure profile from a start of the inspiratory phase to a transition point occurring during the inspiratory phase, and

(2) based on a product of the inspiratory gain and the fluid characteristic from the transition point to the end of the inspiratory phase, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

14. The method of claim 13, wherein the pressure profile corresponds to a time-based transition from a pressure at a start of the inspiratory phase to an inspiratory positive airway pressure (EPAP).

15. The method of claim 13, wherein the signal from the sensor is indicative of the flow of breathing gas, and wherein the transition point is determined based the flow of breathing gas.

16. The method of claim 9, wherein controlling a pressure of the flow of breathing gas delivered to a patient based includes controlling the pressure of the flow of breathing gas based on:

(1) an inspiratory positive airway pressure (IPAP) from a start of the inspiratory phase to a transition point occurring during the inspiratory phase, and

(2) based on a product of the inspiratory gain and the fluid characteristic from the transition point to the end of the inspiratory phase, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

17. A system for delivering pressurized breathing gas to an airway of a patient, comprising:

gas flow generating means for generating a flow of breathing gas;

sensing means for sensing a fluid characteristic associated with the flow of breathing gas and outputting a signal corresponding to the fluid characteristic;

gain selecting means for selecting an inspiratory gain and an expiratory gain; and

pressure regulating means for controlling a pressure of the flow of breathing gas delivered to a patient based on;

(1) a product of the inspiratory gain and the fluid characteristic during at least a portion of an inspiratory phase of such a patient'"'"'s breathing cycle, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic, and

(2) a product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient'"'"'s breathing cycle, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

18. The system of claim 17, wherein sensing means substantially continuously detects the fluid characteristic and substantially continuously outputs the signal indicative of the fluid characteristic.

19. The system of claim 17, wherein controlling a pressure of the flow of breathing gas is done substantially continuously during a breathing cycle based on the output from the sensor, the inspiratory gain, and the expiratory gain.

20. The system of claim 17, wherein the pressure regulating means controls the pressure of the flow of breathing gas according to:

(1) a pressure profile from a start of the inspiratory phase to a transition point occurring during the inspiratory phase, and

(2) based on a product of the inspiratory gain and the fluid characteristic from the transition point to the end of the inspiratory phase, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

21. The system of claim 20, wherein the pressure profile corresponds to a time-based transition from a pressure at a start of the inspiratory phase to an inspiratory positive airway pressure (IPAP).

22. The system of claim 20, wherein the signal from the sensor is indicative of the flow of breathing gas, and wherein the processing means determines the transition point based the flow of breathing gas.

23. The system of claim 17, wherein the pressure controlling means controls the flow of breathing gas based on:

(1) an inspiratory positive airway pressure (IPAP) from a start of the inspiratory phase to a transition point occurring during the inspiratory phase, and

(2) based on a product of the inspiratory gain and the fluid characteristic from the transition point to the end of the inspiratory phase, so that a pressure of the flow of breathing gas delivered to the patient varies with fluctuations of the fluid characteristic.

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

a gas flow generator;

a patient interface coupled to the gas flow generator to communicate a flow of breathing gas from the gas flow generator with an airway of a patient;

a sensor associated with the gas flow generator or the patient interface that detects a fluid characteristic associated with the flow of breathing gas within the patient interface and outputs a signal corresponding to the fluid characteristic;

a pressure controller associated with the gas flow generator or the patient interface to control a pressure of the flow of breathing gas delivered to a patient;

an input device; and

processing means, adapted to receive the signal output from the sensor and an expiratory gain from the input device, for producing a command signal as a product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient'"'"'s breathing cycle, and wherein the processing means provides the command signal to the pressure controller so that a pressure of the breathing gas delivered to a patient varies during at least a portion of the expiratory phase with fluctuations of the fluid characteristic.

25. The apparatus of claim 24, wherein the patient interface includes a conduit, and wherein the pressure controller is a valve associated with the conduit that exhausts gas from the conduit to control the pressure of the flow of breathing gas delivered to the patient.

26. The apparatus of claim 24, wherein the processing means determines the command signal and provides it to the pressure controller substantially continuously.

27. The apparatus of claim 24, wherein the processing means determines the command signal according to:

(1) an inspiratory positive airway pressure (IPAP) during an inspiratory phase of such a patent'"'"'s breathing cycle, and

(2) based on the product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient'"'"'s breathing cycle, so that a pressure of the flow of breathing gas delivered to such a patient during at least a portion of the expiratory phase varies with fluctuations of the fluid characteristic.

28. The apparatus of claim 27, wherein the inspiratory positive airway pressure (IPAP) is set by the processing means based on an input IPAP entered via the input device.

29. A method of delivering pressurized breathing gas to an airway of a patient, comprising:

generating a flow of breathing gas;

sensing a fluid characteristic associated with the flow of breathing gas and outputting a signal corresponding to the fluid characteristic;

selecting an expiratory gain; and

controlling a pressure of the flow of breathing gas delivered to a patient based on a product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient'"'"'s breathing cycle, so that a pressure of the flow of breathing gas delivered to the patient during at least a portion of the expiratory phase varies with fluctuations of the fluid characteristic.

30. The method claim 29, wherein generating the flow of breathing gas includes carrying the flow of breathing gas to an airway of a patient via conduit, and wherein controlling the pressure of the flow of breathing gas includes exhausting gas from the conduit.

31. The method of claim 29, wherein controlling a pressure of the flow of breathing gas is done substantially continuously during at least a portion of the expiratory phase of a breathing cycle based on the output from the sensor and the expiratory gain.

32. The method of claim 29, wherein controlling a pressure of the flow of breathing gas delivered to a patient based includes controlling the pressure of the flow of breathing gas based on:

(1) an inspiratory positive airway pressure (IPAP) during an inspiratory phase of such a patent'"'"'s breathing cycle, and

(2) based on the product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient'"'"'s breathing cycle, so that a pressure of the flow of breathing gas delivered to such a patient during at least a portion of the expiratory phase varies with fluctuations of the fluid characteristic.