Control for CPAP apparatus

• US 5,551,419 A
• Filed: 12/15/1994
• Issued: 09/03/1996
• Est. Priority Date: 12/15/1994
• Status: Expired due to Term

• Current Assignee: DeVilbiss Healthcare LLC
• Original Assignee: DeVilbiss Healthcare LLC
• Inventors: Mitchell, Joseph N., Jones, Stephen M., Froehlich, James P.
• Primary Examiner(s): Funk, Stephen
• Assistant Examiner(s): RACITI, ERIC
• Application Number:
  US08/356,471
• Time in Patent Office: 628 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/205.13, 128/205.18, 128/205.24, 128/205.25
• US Class Current: 128/204.23
• CPC Class Codes: A61M 16/0051 with alarm devices
• 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 16/202 electrically actuated
• 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 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

The invention relates to continuous positive airway pressure (CPAP) respiratory therapy apparatus for treatment of apnea, hypopnea and other sleep disorders, and particularly to a control for the CPAP apparatus. A blower is connected through a hose and a mask, such as a nasal mask or a nasal cannula, to the patient'"'"'s respiratory airway. An air flow sensor and an air pressure sensor are located at the blower end of the hose. Optionally, a vent valve also may be located at the blower end of the hose. The sensor outputs are used to estimate the air pressure at the mask and the air flow sensor output is used to determine the gross air flow to the hose, the patient air flow and the occurrence of patient snoring. The air flow sensor output also is used to generate a square wave breathing signal. The breathing signal may be used by a microprocessor to control the optional vent valve to establish different levels in the applied pressure during inspiration and expiration. The applied CPAP pressure may be increased in response to the detection of apnea and hypopnea events. The microprocessor detects and ignores mask leaks, open mouth breathing and exhale puff breathing.

Claims

1. An improved method for controlling CPAP apparatus adapted to apply a positive airway pressure to a patient, said apparatus including an air blower and means for applying a positive air pressure from said blower through a hose to a mask adapted to be secured to a patient in communications through the patient'"'"'s nose with the patient'"'"'s respiratory airway, said apparatus including means for detecting abnormal breathing events and for automatically increasing the positive airway pressure applied to the patient in response to the detection of at least one abnormal breathing event, said method comprising the steps of:

a) detecting air leakage through the patient'"'"'s mouth caused by the patient maintaining an open mouth while breathing blower air through the nose; and

b) preventing an automatic pressure increase as a consequence of a predetermined high air leakage through the patient'"'"'s open mouth.

2. A method for controlling CPAP apparatus, as set forth in claim 1, and further including the step of preventing an automatic pressure increase as a consequence of a predetermined high leakage between the mask and the patient.

3. A method for controlling CPAP apparatus, as set forth in claim 2, wherein said air leakage through the patient'"'"'s mouth is detected by generating a signal representing the total air flow to the mask, passing the total air flow signal through a high pass filter to establish a signal representing the air flow to the patient'"'"'s respiratory system and wherein the difference between said total air flow signal and said patient air flow signal represents the total of all leakages of air delivered through the hose including leakage through the patient'"'"'s mouth, and wherein said automatic pressure increases are made only in response to a detection of at least one abnormal breathing event in the patient air flow signal.

4. A method for controlling CPAP apparatus, as set forth in claim 3, and further including the step of inhibiting automatic changes in the CPAP pressure when the total of all air leakages full within a predetermined range.

5. An improved method for controlling CPAP apparatus adapted to apply a positive airway pressure to a patient, said apparatus including an air blower and means for applying a positive air pressure from said blower through a hose to a mask adapted to be secured to a patient in communications through the patient'"'"'s nose with the patient'"'"'s respiratory airway, said apparatus including means for detecting abnormal breathing events and for automatically increasing the positive airway pressure applied to the patient in response to the detection of at least one abnormal breathing event, said method comprising the steps of:

a) detecting when the patient inhales air delivered through the mask to the patient'"'"'s nose and in the same breath cycle exhales through the mouth; and

b) preventing an automatic increase in the pressure applied to the patient'"'"'s airway when nose inhalation and mouth exhalation are detected in the same breath cycle.

6. A method for controlling CPAP apparatus, as set forth in claim 5, wherein mouth exhalation is detected by detecting when both the inspiration air flow at the mask during a breath cycle exceeds a predetermined threshold level and at least a portion of the expiration air flow at the mask during such breath cycle is less than a predetermined threshold level.

7. A method for controlling CPAP apparatus, as set forth in claim 6, and further including the step of adjusting the predetermined threshold level upwardly in response to an increase in the patient air flow and downwardly in response to a decrease in the patient air flow.

8. A method for generating a square wave breathing signal indicative of patient inspiration and expiration into a mask comprising the steps of:

a) generating a patient air flow signal indicative of the air flow between the mask and the patient'"'"'s respiratory system, the patient air flow signal having a predetermined level when there is no air flow between the mask and the patient'"'"'s respiratory system;

b) generating an inspiration threshold signal having a level displaced from the predetermined level;

c) generating an expiration threshold signal separate from said inspiration threshold signal and having a level displaced from the predetermined level;

d) switching the breathing signal from a first logic level to a second logic level when the patient air flow signal crosses the inspiration threshold signal during inspiration;

and

e) switching the breathing signal from said second logic level to said first logic level when the patient air flow signal crosses the expiration threshold signal during expiration.

9. A method for generating a square wave breathing signal indicative of patient inspiration and expiration into a mask comprising the steps of:

a) generating a patient air flow signal indicative of the airflow between the mask and the patient'"'"'s respiratory system, the patient air flow signal having a predetermined level when there is no air flow between the mask and the patient'"'"'s respiratory system;

b) generating an inspiration threshold signal having a level displaced from the predetermined level which is a function of the maximum difference between the patient air flow signal during inspiration and the predetermined level, wherein said inspiration threshold signal is generated by rapidly increasing differences between the inspiration threshold signal and the predetermined level in response to increases in the maximum difference between the patient air flow signal during inspiration and the predetermined level and by slowly decreasing differences between the inspiration threshold signal and the predetermined level in response to decreases in the maximum difference between the patient air flow signal during inspiration and the predetermined level;

c) generating an expiration threshold signal having a level displaced from the predetermined level which is a function of the maximum difference between the patient air flow during expiration signal and the predetermined level, wherein said expiration threshold signal is generated by rapidly increasing differences between the expiration threshold signal and the predetermined level in response to increases in the maximum difference between the patient air flow signal during expiration and the predetermined level and by slowly decreasing differences between the expiration threshold signal and the predetermined level in response to decreases in the maximum difference between the patient air flow signal during expiration and the predetermined level;

d) switching the breathing signal from a first logic level to a second logic level when the patient air flow signal crosses the inspiration threshold signal during inspiration;

and

e) switching the breathing signal from said second logic level to said first logic level when the patient air flow signal crosses the expiration threshold signal during expiration.

10. A method for generating a square wave breathing signal indicative of patient inspiration and expiration into the mask comprising the steps of:

a) generating a patient air flow signal indicative of the air flow between the mask and the patient'"'"'s respiratory system, the patient air flow signal having a predetermined level when there is no air flow between the mask and the patient'"'"'s respiratory system;

b) generating an inspiration threshold signal having a level displaced from the predetermined level which is a function of the maximum difference between the patient air flow signal during inspiration and the predetermined level;

c) generating an expiration threshold signal separate from said inspiration threshold signal and having a level displaced from the predetermined level which is a function of the maximum difference between the patient air flow during expiration signal and the predetermined level;

d) switching the breathing signal from a first logic level to a second logic level when the patient air flow signal crosses the inspiration threshold signal during inspiration;

e) switching the breathing signal from said second logic level to said first logic level when the patient air flow signal crosses the expiration threshold signal during expiration;

f) generating a total air flow signal indicative of the total air flow to the mask including any air lost due to leakage;

g) generating the derivative of the total air flow signal, said derivative having a second predetermined level when there is no air flow between the mask and the patient'"'"'s respiratory system;

h) generating a first derivative threshold signal which is a function of the maximum difference between the total air flow derivative and the second predetermined level when the patient'"'"'s breathing is changing from maximum expiration to maximum inspiration;

i) generating a second derivative threshold signal which is a function of the maximum difference between the total air flow derivative and the second predetermined level when the patient'"'"'s breathing is changing from maximum inspiration to maximum expiration;

j) switching the breathing signal from the first logic level to the second logic level when the total air flow derivative exceeds the first derivative threshold signal while said patient air flow signal is between the inspiration and expiration threshold signal levels; and

k) switching the breathing signal from the second logic level to the first logic level when the total air flow derivative exceeds the second derivative threshold signal while the patient air flow signal is between the inspiration and expiration threshold signal levels.

11. In CPAP apparatus adapted to apply a positive airway pressure to a patient, said apparatus including an air blower having a positive pressure output applied through a hose to a mask adapted to be secured to a patient in communications with the patient'"'"'s respiratory airway, a method for detecting patient snoring comprising the steps of:

a) generating a signal corresponding to the mass air flow in the hose at the end of the hose which receives air from the blower;

b) passing said mass air flow signal through a band pass filter to obtain a first signal consisting primarily of snoring information and noise;

c) establishing a threshold signal based primarily on the level of non snoring noise in said mass air flow signal;

d) comparing said first signal to said threshold signal and generating a snoring signal whenever said first signal exceeds said threshold signal.

12. A method for detecting patient snoring in CPAP apparatus, as set forth in claim 11, and wherein said threshold signal is established by passing said mass air flow signal through a high pass filter which removes any low frequency noise and snoring noise to establish a second signal, generating the mean absolute value of said second signal and wherein said threshold signal is a function of the mean absolute value of said second signal.

13. A method for detecting patient snoring in CPAP apparatus, as set forth in claim 11, wherein said mass air flow signal is passed through a band pass filter having a center frequency of about 70 Hz and passband of about 7 Hz.

14. In CPAP apparatus which includes blower means for creating a positive air pressure, a mask adapted to be attached to a patient in communications with the patient'"'"'s respirator system and a hose having a first end for receiving a flow of positive pressure air from said blower means and a second end for delivering such flow of positive pressure air to said mask, apparatus for detecting when a patient is snoring comprising means for generating a first electric signal indicative of the mass air flow at said first hose end, such mass air flow including a first component resulting from air flow from said blower means, a second component resulting from patient inspiration and expiration at said mask, a third component comprising noise resulting from patient snoring, and a fourth component comprising noise other than snoring noise, band pass filter means responsive to the first signal for establishing a second electric signal consisting of snoring and non snoring noise, means responsive to the fourth component of the first signal for establishing a snoring threshold level signal, and means for indicating the presence of snoring when the second signal exceed the snoring threshold level signal.

15. Apparatus for detecting when a patient is snoring, as set forth in claim 14, wherein said means responsive to the fourth component of the first signal for establishing a snoring threshold level signal comprises a high pass filter for removing the first, second and third components from the first signal to establish a third electric signal based on said forth component, and means responsive to the third signal for establishing the snoring threshold level signal as a function of the mean absolute value of the third signal.