Determination of mask fitting pressure and correct mask fit

• US 6,425,395 B1
• Filed: 12/21/1999
• Issued: 07/30/2002
• Est. Priority Date: 12/21/1998
• Status: Expired due to Term

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Farrugia, Steven Paul, Brewer, Gregory Newton, Somaiya, Chinmayee, Colla, Gregory Alan
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): PATEL, MITAL B
• Application Number:
  US09/469,954
• Time in Patent Office: 952 Days
• Field of Search: 128/204.18, 128/202.22, 128/204.21, 128/204.23
• US Class Current: 128/202.22
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• 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 16/0605 Means for improving the adaptation of the mask to the patient
• 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 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A62B 27/00 Methods or devices for testing respiratory or breathing apparatus for high altitudesapparatus for testing gastightness in general G01M

Abstract

A CPAP treatment apparatus, as one form of positive pressure ventilatory assistance, includes a turbine/blower, operated by a mechanically coupled electrical motor that receives air or breathable gas at an inlet thereof, and supplies the breathable gas at a delivery pressure to a delivery tube/hose having a connection at the other end thereof with a nose mask. A microcontroller has an operational “Mask-Fit” mode. An initial constant pressure level is applied by the blower to the mask. If the functional mode is a manual mode, then the mask-fit test pressure is the current ‘set’ pressure. If the functional mode is the automatic titration mode, the mask-fit test pressure is the 95^th percentile pressure of the previous session, otherwise it is the base treatment pressure, e.g. 10-12 cm H₂O. This constant pressure is applied for a period of time, typically 1-3 minutes. The microcontroller continuously determines mask leak as the value, f_LEAK, from a flow sensor, comparing this to a threshold, and providing the patent with a visual indication of degree of leak. In this way the patient can manipulate the mask to ensure correct fitting as indicated by the appropriate message or indication.

Claims

1. A ventilatory assistance apparatus comprising:

a controllable flow generator providing a positive pressure of breathable gas;

a conduit coupled to the flow generator to receive said gas;

a mask to be worn by a wearer, in turn, to receive said gas from said conduit as a desired pressure; and

a controller having a control of said flow generator and programmed to cause a mask-fit test pressure to be applied at the mask, said test pressure being determined as a percentile pressure of a previous ventilatory assistance session.

2. The apparatus of claim 1, further comprising:

flow sensor means, for sensing respiratory flow, passing a flow signal to the controller; and

display or indication means; and

wherein the controller is further operable to determine mask leak flow at the test pressure from the respiratory flow signal, and to cause the display or indication means to display or otherwise indicate the magnitude of the leak flow as an indication of correct mask fitting.

3. The apparatus of claim 2, wherein the controller further has a manual pressure mode in which a currently set ventilatory assistance pressure is chosen to be applied as the test pressure.

4. The apparatus of claim 3, wherein said controller applies the test pressure for a period of time.

5. The apparatus as claimed in claim 4, wherein said time is three minutes.

6. The apparatus of claim 2, wherein said controller quantises said leak flow to represent a degree of leak.

7. The apparatus of claim 6, wherein the controller is further operable to compare said leak flow against a threshold value representing zero degree of leak, and to determine that there is correct mask fitting if the threshold is not exceeded.

8. The apparatus of claim 7, wherein, if there is no previous percentile pressure available, then the controller determines that a base pressure is to be applied, as said test pressure.

9. The apparatus of claim 8, wherein said percentile pressure is chosen from be range of the 75^th-95^th percentile pressure.

10. The apparatus of claim 9, wherein said base pressure is in the range 10-12 cmH₂O.

11. The apparatus of claim 10, wherein said controller is further operable to determine that a previous pressure is available if a previous ventilatory assistance session occurred for greater than a predetermined time interval.

12. The apparatus of claim 11, wherein said predetermined time interval is three hours.