Pressure support system with a low leak alarm and method of using same

• US 6,536,432 B2
• Filed: 01/10/2002
• Issued: 03/25/2003
• Est. Priority Date: 11/25/1998
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: Respironics Incorporated
• Inventors: Truschel, William A.
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US10/043,773
• Publication Number:
  US 20020088464A1
• Time in Patent Office: 439 Days
• Field of Search: 128/202.22, 128/204.18, 128/204.21, 128/204.23
• US Class Current: 128/205.23
• 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 16/0072 Tidal volume piston pumps
• 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 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 2205/3561 local, e.g. within room or hospital

Abstract

A pressure support system and method of using same that includes a pressure generator adapted to provide a gas flow, a conduit coupled to the pressure generator to deliver a gas flow to a patient, an interface device coupled to the conduit to communicate the gas flow to an airway of the patient. An exhaust vent that provides a flow of exhaust gas to atmosphere is provided in the conduit or the interface device. A flow sensor detects a rate at which gas flows in the conduit and provides a first output indicative thereof, and a pressure sensor detects a pressure of gas at the patient and provides a second output indicative thereof. A control system receives the first and second outputs and determines whether a current flow of exhaust gas passing through the exhaust vent is below an alarm threshold based on the first and second outputs and provides a third output indicative of this determination.

Claims

1. A pressure support system comprising:

a pressure generator adapted to provide a gas flow;

a conduit operatively coupled to said pressure generator to deliver a gas flow to a patient;

an interface device operatively coupled to said conduit to communicate a gas flow to an airway of a patient, wherein at least one of said conduit and said interface device includes an exhaust vent that provides a flow of exhaust gas to atmosphere from a respective one of said conduit and said interface device;

a flow sensor operatively coupled to said conduit to detect a rate at which gas flows in said conduit, and wherein said flow sensor outputs a flow signal indicative of said rate;

a pressure sensor operatively coupled to said conduit or said interface device to detect a pressure of said flow of gas in said conduit or said interface device, respectively, and wherein said pressure sensor outputs a pressure signal indicative of said pressure of said flow of gas in said conduit or said interface device; and

processing means, receiving said flow signal and said pressure signal, for determining based thereon whether a current flow of exhaust gas passing through said exhaust vent is below an alarm threshold.

2. A pressure support system according to claim 1, further comprising an alarm device operatively coupled to said processing means to receive said output, wherein said processing means actuates said alarm device responsive to said current flow of exhaust gas being below such an alarm threshold for a predetermined period of time.

3. A pressure support system according to claim 1, wherein said processing means sets said alarm threshold according to at least one detected condition of said pressure support system determined during a learn period, wherein said learn period is a period of time in which at least one parameter associated with said pressure support system is monitored by said processing means using at least one of said flow sensor and said pressure sensor.

4. A pressure support system according to claim 3, further comprising a manual input device operatively coupled to said processing means, wherein said pressure support system is capable of being operated in a plurality of modes, and wherein (1) actuating said manual input device, (2) starting up said pressure support system, or (3) changing a mode of operation of said pressure support system causes said processing means to execute said learn period.

5. A pressure support system according to claim 3, wherein said detected conditions include said rate at which gas flows in said conduit and said pressure of gas at a patient, and wherein said processing means (1) determines a first relationship defined as:

${\int <br><br>}^{T_{\mathrm{break}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t$

during said learn period, where Q_c is a current flow of gas within said conduit, Q_known is a predetermined flow of exhaust gas passing through said exhaust vent, and T_breath is an integral number of breathing cycles, and (2) sets said alarm threshold based on a first set of criteria responsive to said first relationship being negative and based on a second set of criteria responsive to said first relationship not being negative.

6. A pressure support system according to claim 5, said processing means calculates a second relationship, R_leak, defined as:

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{break}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{T_{\mathrm{breath}}},$

and wherein said processing means sets said alarm threshold as one of (1) a predetermined percentage less than a sum of Q_known, and R_leak and (2) a predetermined amount less than a sum of Q_known, and R_leak, responsive to said first relationship determined during said learn period being negative.

7. A pressure support system according to claim 5, wherein said processing means also monitors said first relationship during normal operation of said pressure support system and changes from said first set of criteria to said second set of criteria by which said alarm threshold is set responsive to said first relationship not being negative for a predetermined period of time and thereafter adjusts said alarm threshold according to said second set of criteria.

8. A pressure support system according to claim 5, wherein Q_known is determined by one of:

(1) performing an exhaust vent test that includes;

(a) providing a plurality of pressures to a patient via said pressure generator,

(b) measuring a current flow of gas within said conduit associated with each of said plurality of pressures,

(c) establishing a pressure versus flow relationship for said exhaust vent based on said plurality of pressures and flow associated therewith, and

(d) setting Q_known based on said pressure versus flow relationship;

(2) recalling Q_known from a database based on said exhaust vent being used with said pressure support system, wherein said data base contains a plurality of pressure verses flow relationships associated with various types of exhaust vents; and

(3) setting Q_known to zero if both steps (1) and (2) are not performed.

9. A pressure support system according to claim 8, wherein said processing means sets said alarm threshold as one of (1) a predetermined percentage of Q_known and (2) a predetermined amount less than Q_known, responsive to said first relationship determined during said learn period not being negative and one of (1) said exhaust vent test having been performed and (2) Q_known having been recalled from said database, and wherein said processing means sets said alarm threshold as one of (1) a predetermined percentage of a predetermined minimum exhaust vent leakage rate and (2) a predetermined amount less than said predetermined minimum exhaust vent leakage rate responsive to said first relationship determined during said learn period not being negative and said exhaust vent test and recalling of Q_known from said database having not been performed.

10. A pressure support system according to claim 9, wherein said processing means determines, during normal operation of said pressure support system, whether a current flow of exhaust gas passing through said exhaust vent is below said alarm threshold by determining whether said first relationship is negative, and

wherein said processing means calculates, during normal operation, a constant R_leak according to a second relationship defined as:

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{break}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{{\int <br><br>}^{T_{\mathrm{break}}}<br><br>\sqrt{P_p}<br><br><br><br>t}$

if said first relationship is not negative, wherein P_p is a pressure at an airway of a patient, and according to a third relationship defined as;

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{break}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{T_{\mathrm{breath}}}$

if said first relationship is negative, and

wherein said processing means, during normal operation, provides said third output based on whether a fourth relationship defined as Q_known+R_leak{square root over (P_p)} is less than said alarm threshold for a first predetermined period of time, responsive to R_leak not being negative, and wherein said processing means provides said third output based on whether a fifth relationship defined as Q_known+R_leak is less than said alarm threshold for a second predetermined period of time, responsive to R_leak being negative.

11. A pressure support system according to claim 1, wherein said processing means determines, during normal operation of said pressure support system, whether a current flow of exhaust gas passing through said exhaust vent is below said alarm threshold by determining whether a first relationship defined as:

${\int <br><br>}^{T_{\mathrm{break}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t$

is negative, where Q_c is a flow of gas within said conduit, Q_known is a predetermined rate of flow of exhaust gas passing through said exhaust vent, and T_breath is an integral number of breathing cycles.

12. A pressure support system according to claim 11, wherein said processing means determines whether said current rate of flow of exhaust gas passing through said exhaust vent is below said alarm threshold by calculating a constant R_leak according to a second relationship defined as:

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{break}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{{\int <br><br>}^{T_{\mathrm{break}}}<br><br>\sqrt{P_p}<br><br><br><br>t}$

if said first relationship is not negative, wherein P_p is a pressure at an airway of a patient, and according to a third relationship defined as;

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{T_{\mathrm{breath}}}$

if said first relationship is negative.

13. A pressure support system according to claim 12, wherein said processing means, during normal operation, provides said third output based on whether a fourth relationship defined as Q_known+R_leak{square root over (P_p)} is less than said alarm threshold for a first predetermined period of time, responsive to R_leak not being negative, and wherein said processing means provides said third output based on whether a fifth relationship defined as Q_known+R_leak is less than said alarm threshold for a second predetermined period of time, responsive to R_leak being negative.

14. A pressure support system according to claim 12, wherein said pressure sensor is operatively coupled to said conduit proximate to said pressure generator, and wherein said processing means estimates a pressure at said patient based on said pressure signal and uses said estimated pressure at said patient in determining whether said current flow of exhaust gas passing through said exhaust vent is below an alarm threshold.

15. A method of providing pressure support including a low leak alarm comprising the steps of:

providing a gas flow from a pressure generator to a patient via a conduit operatively coupled to said pressure generator, wherein an interface device is also coupled to said conduit to communicate a gas flow from said conduit to an airway of a patient, and wherein an exhaust vent in disposed in said interface device or a portion of said conduit proximate to said interface device to communicate a flow of exhaust gas to atmosphere from a respective one of said conduit and said interface device;

measuring a rate at which gas flows in said conduit and providing a first output indicative thereof;

measuring a pressure of gas in said conduit or in said interface device and providing a second output indicative thereof; and

determining whether a current flow of exhaust gas passing through said exhaust vent is below an alarm threshold based on said first output and said second output.

16. A method according to claim 15, further comprising a step of outputting a human perceivable alarm responsive to said current flow of said exhaust gas being below such an alarm threshold for a predetermined period of time.

17. A method according to claim 15, further comprising the steps of:

monitoring said rate at which gas flows in said conduit and said pressure of gas in said conduit or said patient interface device during a learn period; and

setting said alarm threshold based on said monitored gas flow in said conduit and said pressure of gas in said conduit or said patient interface device during said learn period.

18. A method according to claim 17, wherein said monitoring step includes determining a first relationship defined as:

${\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t$

during said learn period, where Q_c is a current flow of gas within said conduit, Q_known is a predetermined flow of exhaust gas passing through said exhaust vent, and T_breath is an integral number of breathing cycles; and

wherein said alarm threshold setting step includes setting said alarm threshold based on a first set of criteria responsive to said first relationship being negative and setting said alarm threshold based on a second set of criteria responsive to said first relationship not being negative.

19. A method according to claim 18, further comprising a step of calculating a second relationship, R_leak, defined as:

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{T_{\mathrm{breath}}},$

and wherein said setting step includes setting said alarm threshold as one of (1) a predetermined percentage less than a sum of Q_known and R_leak and (2) a predetermined amount less than a sum of Q_known, and R_leak, responsive to said first relationship determined during said learn period being negative.

20. A method according to claim 18, further comprising the steps of:

monitoring said first relationship during normal operation of said pressure support system;

changing from said first set of criteria to said second set of criteria by which said alarm threshold is set responsive to said first relationship not being negative for a predetermined period of time; and

adjusting said alarm threshold based on said second set of criteria.

21. A method according to claim 18, further comprising the step of determining Q_known by performing the following steps:

(1) performing an exhaust vent test by performing the following steps;

(a) providing a plurality of pressures to a patient via said pressure generator,

(b) measuring a current flow of gas within said conduit associated with each of said plurality of pressures,

(c) establishing a pressure versus flow relationship for said exhaust vent based on said plurality of pressures and rates of flow associated therewith, and

(d) setting Q_known based on said pressure versus flow relationship;

(2) recalling Q_known from a database based on said exhaust vent being used with said pressure support system, wherein said database contains a plurality of pressure verses flow relationships associated with various types of exhaust vents; and

(3) setting Q_known to zero if both steps (1) and (2) are not performed.

22. A method according to claim 21, wherein said alarm threshold setting step includes setting said alarm threshold as (1) a predetermined percentage of Q_known or (2) a predetermined amount less than Q_known, responsive to said first relationship determined during said learn period not being negative and one of (1) said exhaust vent test having been performed and (2) Q_known having been recalled from said database, and wherein said alarm threshold is set as (1) a predetermined percentage of a predetermined minimum exhaust vent leakage rate or (2) a predetermined amount less than said predetermined minimum exhaust vent leakage rate responsive to said first relationship determined during said learn period not being negative and said exhaust vent test and recalling Q_known from said database having not been performed.

23. A method according to claim 22, wherein said determining step includes determining, during normal operation, whether a current rate of flow of exhaust gas passing through said exhaust vent is below said alarm threshold by determining whether a first relationship defined as:

${\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t$

is negative, where Q_c is a flow of gas within said conduit, Q_known is a predetermined flow of exhaust gas passing through said exhaust vent, and T_breath is an integral number of breathing cycles, further comprising;

calculating a constant R_leak according to a second relationship defined as;

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\sqrt{P_p}<br><br><br><br>t}$

if said first relationship is not negative, wherein P_p is a pressure at an airway of a patient; and

calculating a constant R_leak according to a third relationship defined as;

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{T_{\mathrm{breath}}}$

if said first relationship is negative;

outputting a low leak alarm responsive to a fourth relationship defined as Q_known+R_leak{square root over (P_p)} being less than said alarm threshold for a first predetermined period of time, responsive to R_leak not being negative; and

outputting a low leak alarm responsive to a fifth relationship defined as Q_known+R_leak being less than said alarm threshold for a second predetermined period of time, responsive to R_leak being negative.

24. A method according to claim 15, wherein said determining step includes determining, during normal operation, whether a current flow of exhaust gas passing through said exhaust vent is below said alarm threshold by determining whether a first relationship defined as:

${\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t$

is negative, where Q_c is a flow of gas within said conduit, Q_known is a predetermined rate of flow of exhaust gas passing through said exhaust vent, and T_breath is an integral number of breathing cycles.

25. A method according to claim 24, further comprising the steps of calculating a system constant R_leak according to a second relationship defined as:

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\sqrt{P_p}<br><br><br><br>t}$

if said first relationship is not negative, wherein P_p is a pressure at an airway of a patient; and

calculating a system constant R_leak according to a third relationship defined as;

$R_{\mathrm{leak}}=\frac{{\int <br><br>}^{T_{\mathrm{breath}}}<br><br>\left(Q_c-Q_{\mathrm{known}}\right)<br><br><br><br>t}{T_{\mathrm{breath}}}$

if said first relationship is negative.

26. A method according to claim 25, further comprising the steps of:

determining whether R_leak not being positive;

outputting a low leak alarm responsive to a fourth relationship defined as Q_known+R_leak{square root over (P_p)} being less than said alarm threshold for a first predetermined period of time, responsive to R_leak not being negative; and

outputting a low leak alarm responsive to a fifth relationship defined as Q_known+R_leak being less than said alarm threshold for a second predetermined period of time, responsive to R_leak being negative.

27. A method according to claim 15, wherein said pressure of said gas is measured in said conduit at a location proximate to said pressure generator, further comprising estimating a pressure at said patient based on said pressure signal, and wherein determining whether a current flow of exhaust gas passing through said exhaust vent is below an alarm threshold is done based on said estimated pressure at said patient.