U.S. patent application number 11/485819 was filed with the patent office on 2007-03-01 for breathing gas delivery method and apparatus.
This patent application is currently assigned to RIC Investments, Inc.. Invention is credited to Mark Estes, Mark Sanders, Ronald J. Zdrojkowski.
Application Number | 20070044796 11/485819 |
Document ID | / |
Family ID | 23373301 |
Filed Date | 2007-03-01 |
United States Patent
Application |
20070044796 |
Kind Code |
A1 |
Zdrojkowski; Ronald J. ; et
al. |
March 1, 2007 |
Breathing gas delivery method and apparatus
Abstract
An improved methodology and systems for delivery of breathing
gas such as for the treatment of obstructive sleep apnea through
application of alternating high and low level positive airway
pressure within the airway of the patient with the high and low
airway pressure being coordinated with the spontaneous respiration
of the patient, and improved methods and apparatus for triggering
and for leak management in such systems.
Inventors: |
Zdrojkowski; Ronald J.;
(Murrysville, PA) ; Estes; Mark; (Northridge,
CA) ; Sanders; Mark; (Wexford, PA) |
Correspondence
Address: |
MICHAEL W. HAAS;RESPIRONICS, INC.
1010 MURRY RIDGE LANE
MURRYSVILLE
PA
15668
US
|
Assignee: |
RIC Investments, Inc.
Wilmington
DE
|
Family ID: |
23373301 |
Appl. No.: |
11/485819 |
Filed: |
July 13, 2006 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11139235 |
May 27, 2005 |
7100607 |
|
|
11485819 |
Jul 13, 2006 |
|
|
|
10378369 |
Mar 3, 2003 |
6948497 |
|
|
11139235 |
May 27, 2005 |
|
|
|
09966547 |
Sep 26, 2001 |
6539940 |
|
|
10378369 |
Mar 3, 2003 |
|
|
|
09483538 |
Jan 14, 2000 |
6305374 |
|
|
09966547 |
Sep 26, 2001 |
|
|
|
08823855 |
Mar 25, 1997 |
6029664 |
|
|
09483538 |
Jan 14, 2000 |
|
|
|
08349634 |
Dec 2, 1994 |
5632269 |
|
|
08823855 |
Mar 25, 1997 |
|
|
|
07947156 |
Sep 18, 1992 |
5433193 |
|
|
08349634 |
Dec 2, 1994 |
|
|
|
07411012 |
Sep 22, 1989 |
5148802 |
|
|
07947156 |
Sep 18, 1992 |
|
|
|
Current U.S.
Class: |
128/204.18 |
Current CPC
Class: |
A61M 2205/15 20130101;
A61M 2016/0036 20130101; A61M 2016/0021 20130101; A61M 16/0069
20140204; A61M 16/204 20140204; A61M 2205/3561 20130101; A61M
16/0066 20130101; A61M 16/026 20170801; A61M 16/205 20140204; A61M
16/06 20130101 |
Class at
Publication: |
128/204.18 |
International
Class: |
A61M 16/00 20060101
A61M016/00 |
Claims
1-10. (canceled)
11. A method of medical treatment for a patient comprising the
steps of: providing a flow of breathing gas from a source for
delivery to an airway of such a patient at pressure magnitudes that
vary with such a patient's respiratory cycle; monitoring a
parameter indicative of a flow of the breathing gas flowing between
the source and the airway of such a patient; processing the
parameter indicative of the flow to provide a reference indicia;
and utilizing the parameter, the reference indicia, or both the
parameter and the reference indicia to apply a variable pressure in
the airway of such a patient such that an average of the pressure
applied in the airway of such a patient during inspiration is
higher than an average of the pressure applied in the airway of
such a patient during expiration.
12. The method of claim 11, wherein the parameter indicative of a
flow of the breathing gas the monitoring step is an output of a
flow sensor disposed so as to measure a flow of the breathing gas
between the source and the airway of such as patient.
13. The method of claim 11, wherein the reference indicia is (1) an
average flow of breathing gas flowing between the source and such a
patient or (2) the average flow of breathing gas flowing between
the source and such a patient with an offset.
14. The method of claim 11, wherein the variable pressure includes
an inspiratory positive airway pressure (IPAP) and an expiratory
positive airway pressure (EPAP) that is less that the IPAP, and
wherein the utilizing step includes applying the IPAP during
inspiration and the EPAP during expiration.
15. The method of claim 14, further comprising: selecting the IPAP;
selecting the EPAP; or selecting both the IPAP and the EPAP.
16. The method of claim 15, wherein selecting the IPAP, the EPAP,
or both is done manually.
17. The method of claim 11, wherein the pressure applied in the
airway of such a patient during inspiration is a pressure
sufficient to treat sleep apnea syndrome.
18. The method of claim 11, wherein the pressure applied in the
airway of such a patient during inspiration is set based on a sleep
study.
19. The method of claim 11, wherein the pressure applied to the
airway of such a patient is substantially constant during a
majority of an inspiratory phase of such a patient's breathing
cycle.
20. The method of claim 11, wherein the step of monitoring the
parameter indicative of the flow of the breathing gas is performed
repeatedly during the respiratory cycle of such a patient.
21. A method of medical treatment for a patient comprising the
steps of: providing a flow of breathing gas from a source for
delivery to an airway of such a patient at pressure magnitudes that
vary with such a patient's respiratory cycle; providing a signal
indicative of a characteristic of a flow of the breathing gas
flowing between the source and the airway of such a patient;
determining a reference indicia based on the signal; and applying a
variable pressure in the airway of such a patient, based on the
signal, the reference indicia, or both the signal and the reference
indicia, such that an average of the pressure applied in the airway
of such a patient during inspiration is higher than an average of
the pressure applied in the airway of such a patient during
expiration.
22. The method of claim 21, wherein the signal corresponds to an
output of a flow sensor disposed so as to measure a flow of the
breathing gas between the source and the airway of such as
patient.
23. The method of claim 21, wherein the reference indicia is (1) an
average flow of breathing gas flowing between the source and such a
patient or (2) the average flow of breathing gas flowing between
the source and such a patient with an offset.
24. The method of claim 21, wherein the variable pressure includes
an inspiratory positive airway pressure (IPAP) and an expiratory
positive airway pressure (EPAP), and wherein the applying step
includes providing the IPAP during inspiration and the EPAP during
expiration.
25. The method of claim 24, further comprising: selecting the IPAP;
selecting the EPAP; or selecting both the IPAP and the EPAP.
26. The method of claim 25, wherein selecting the IPAP, the EPAP,
or both is done manually.
27. The method of claim 21, wherein the pressure applied in the
airway of such a patient during inspiration is a pressure
sufficient to treat sleep apnea syndrome.
28. The method of claim 21, wherein the pressure applied in the
airway of such a patient during inspiration is set based on a sleep
study.
29. The method of claim 21, wherein the pressure applied to the
airway of such a patient is substantially constant during a
majority of an inspiratory phase of such a patient's breathing
cycle.
30. The method of claim 21, wherein the step of providing the
signal indicative of the characteristic of the flow of the
breathing gas is performed repeatedly during the respiratory cycle
of such a patient.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
11/139,235 filed May 27, 2005, now U.S. Pat. No. 7,100,607, which
is a Continuation of U.S. patent application Ser. No. 10/378,369
filed Mar. 3, 2003, now U.S. Pat. No. 6,948,497, which is a
Continuation of U.S. patent application Ser. No. 09/966,547 filed
Sep. 26, 2001, now U.S. Pat. No. 6,539,940, which is a Continuation
of U.S. patent application Ser. No. 09/483,538 filed Jan. 14, 2000,
now U.S. Pat. No. 6,305,374, which is a Continuation of U.S. patent
application Ser. No. 08/823,855 filed Mar. 25, 1997, now U.S. Pat.
No. 6,029,664; which is a Continuation of U.S. patent application
Ser. No. 08/349,634 filed Dec. 2, 1994, now U.S. Pat. No.
5,632,269; which is a Continuation-in-Part of U.S. application Ser.
No. 07/947,156 filed Sep. 18, 1992, now U.S. Pat. No. 5,433,193;
which is a Continuation-in-Part of U.S. patent application Ser. No.
07/411,012 filed Sep. 22, 1989, now U.S. Pat. No. 5,148,802.
BACKGROUND OF THE INVENTION
[0002] The sleep apnea syndrome, and in particular obstructive
sleep apnea, afflict an estimated 4% to 9% of the general
population and is due to episodic upper airway obstruction during
sleep. Those afflicted with obstructive sleep apnea experience
sleep fragmentation and intermittent, complete or nearly complete
cessation of ventilation during sleep with potentially severe
degrees of oxyhemoglobin unsaturation. These features may be
translated clinically into debilitating daytime sleepiness, cardiac
disrhythmias, pulmonary-artery hypertension, congestive heart
failure and cognitive dysfunction. Other seqelae of sleep apnea
include right ventricular dysfunction with cor pulmonale, carbon
dioxide retention during wakefulness as well as during sleep, and
continuous reduced arterial oxygen tension. Hypersomnolent sleep
apnea patients may be at risk for excessive mortality from these
factors as well as from an elevated risk for accidents such as
while driving or operating other potentially dangerous
equipment.
[0003] Although details of the pathogenesis of upper airway
obstruction in sleep apnea patients have not been fully defined, it
is generally accepted that the mechanism includes either anatomic
or functional abnormalities of the upper airway which result in
increased air flow resistance. Such abnormalities may include
narrowing of the upper airway due to suction forces evolved during
inspiration, the effect of gravity pulling the tongue back to
appose the pharyngeal wall, and/or insufficient muscle tone in the
upper airway dilator muscles. It has also been hypothesized that a
mechanism responsible for the known association between obesity and
sleep apnea is excessive soft tissue in the anterior and lateral
neck which applies sufficient pressure in internal structures to
narrow the airway.
[0004] The treatment of sleep apnea has included such surgical
interventions as uvalopalatopharyngoplasty, gastric surgery for
obesity, and maxillo-facial reconstruction. Another mode of
surgical intervention used in the treatment of sleep apnea is
tracheostomy. These treatments constitute major undertakings with
considerable risk of post-operative morbidity if not mortality.
Pharmacologic therapy has in general been disappointing, especially
in patients with more than mild sleep apnea. In addition, side
effects from the pharmacologic agents that have been used are
frequent. Thus, medical practitioners continue to seek non-invasive
modes of treatment for sleep apnea with high success rates and high
patient compliance including, for example in cases relating to
obesity, weight loss through a regimen of exercise and regulated
diet.
[0005] Recent work in the treatment of sleep apnea has included the
use of continuous positive airway pressure (CPAP) to maintain the
airway of the patient in a continuously open state during sleep.
For example, U.S. Pat. No. 4,655,213 and Australian patent
AU-B-83901/82 both disclose sleep apnea treatments used on
continuous positive airway pressure, applied within the airway of
the patient.
[0006] Also of interest is U.S. Pat. No. 4,773,411 which discloses
a method and apparatus for ventilatory treatment characterized as
airway pressure release ventilation and which provides a
substantially constant elevated airway pressure with periodic short
term reductions of the elevated airway pressure to a pressure
magnitude no less than ambient atmospheric pressure.
[0007] Publications pertaining to the application of CPAP in
treatment of sleep apnea include the following:
[0008] 1. Lindsay, D A, Issa F G, and Sullivan C. E. "Mechanisms of
Sleep Desaturation in Chronic Airflow Limitation Studied with Nasal
Continuous Positive Airway Pressure (CPAP)", Am Rev Respir Dis.,
1982; 125: p. 112.
[0009] 2. Sanders M H, Moore S E, Eveslage J. "CPAP via nasal mask:
A treatment for occlusive sleep apnea", Chest, 1983; 83: pp.
144-145.
[0010] 3. Sullivan C E, Berthon-Jones M, Issa F G. "Remission of
severe obesity-hypoventilation syndrome after short-term treatment
during sleep with continuous positive airway pressure", Am Rev
Respir Dis, 1983; 128: pp. 177-181.
[0011] 4. Sullivan C E, Issa F G, Berthon-Jones M, Eveslage.
"Reversal of obstructive sleep apnea by continuous positive airway
pressure applied through the nares", Lancet, 1981; 1: pp.
862-865.
[0012] 5. Sullivan C E, Berthon-Jones M. Issa F G. "Treatment of
obstructive apnea with continuous positive airway pressure applied
through the nose", Am Rev Respir Dis, 1982; 125: p. 107. Annual
Meeting Abstracts.
[0013] 6. Rapoport D M, Sorkin B, Garay S M, Goldring R M.
"Reversal of the Pickwickian Syndrome by long-term use of nocturnal
nasal-airway pressure", N Engl J. Med. 1982; 307: pp. 931-933.
[0014] 7. Sanders M H, Holzer B C, Pennock B E. "The effect of
nasal CPAP on various sleep apnea patterns", Chest, 1983; 84: p.
336.
[0015] Presented at the Annual Meeting of the American College of
Chest Physicians, Chicago Ill., October 1983.
[0016] Although CPAP has been found to be very effective and well
accepted, it suffers from some of the same limitations, although to
a lesser degree, as do the surgical options; specifically, a
significant proportion of sleep apnea patients do not tolerate CPAP
well. Thus, development of other viable non-invasive therapies has
been a continuing objective in the art.
BRIEF SUMMARY OF THE INVENTION
[0017] The present invention contemplates a novel and improved
method for treatment of sleep apnea as well as novel methodology
and apparatus for carrying out such improved treatment method. The
invention contemplates the treatment of sleep apnea through
application of pressure at variance with ambient atmospheric
pressure within the upper airway of the patient in a manner to
promote dilation of the airway to thereby relieve upper airway
occlusion during sleep.
[0018] In one embodiment of the invention, positive pressure is
applied alternately at relatively higher and lower pressure levels
within the airway of the patient so that the pressure-induced force
applied to dilate the patient's airway is alternately a larger and
a smaller magnitude dilating force. The higher and lower magnitude
positive pressures are initiated by spontaneous patient respiration
with the higher magnitude pressure being applied during inspiration
and the lower magnitude pressure being applied during
expiration.
[0019] The invention further contemplates a novel and improved
apparatus which is operable in accordance with a novel and improved
method to provide sleep apnea treatment. More specifically, a flow
generator and an adjustable pressure controller supply air flow at
a predetermined, adjustable pressure to the airway of a patient
through a flow transducer. The flow transducer generates an output
signal which is then conditioned to provide a signal proportional
to the instantaneous flow rate of air to the patient. The
instantaneous flow rate signal is fed to a low pass filter which
passes only a signal indicative of the average flow rate over time.
The average flow rate signal typically would be expected to be a
value representing a positive flow as the system is likely to have
at least minimal leakage from the patient circuit (e.g. small leaks
about the perimeter of the respiration mask worn by the patient).
The average flow signal is indicative of leakage because the
summation of all other components of flow over time must be
essentially zero since inspiration flow must equal expiration flow
volume over time, that is, over a period of time the volume of air
breathed in equals the volume of the gases breathed out.
[0020] Both the instantaneous flow signal and the average flow rate
signal are fed to an inspiration/expiration decision module which
is, in its simplest form, a comparator that continually compares
the input signals and provides a corresponding drive signal to the
pressure controller. In general, when the instantaneous flow
exceeds average flow, the patient is inhaling and the drive signal
supplied to the pressure controller sets the pressure controller to
deliver air, at a preselected elevated pressure, to the airway of
the patient. Similarly, when the instantaneous flow rate is less
than the average flow rate, the patient is exhaling and the
decision circuitry thus provides a drive signal to set the pressure
controller to provide a relatively lower magnitude of pressure in
the airway of the patient. The patient's airway thus is maintained
open by alternating higher and lower magnitudes of pressure which
are applied during spontaneous inhalation and exhalation,
respectively.
[0021] As has been noted, some sleep apnea patients do not tolerate
standard CPAP therapy. Specifically, approximately 25% of patients
cannot tolerate CPAP due to the attendant discomfort. CPAP mandates
equal pressures during both inhalation and exhalation. The elevated
pressure during both phases of breathing may create difficulty in
exhaling and the sensation of an inflated chest. However, we have
determined that although both inspiratory and expiratory air flow
resistances in the airway are elevated during sleep preceding the
onset of apnea, the airway flow resistance may be less during
expiration than during inspiration. Thus it follows that the
bi-level CPAP therapy of our invention as characterized above may
be sufficient to maintain pharyngeal patency during expiration even
though the pressure applied during expiration is not as high as
that needed to maintain pharyngeal patency during inspiration. In
addition, some patients may have increased upper airway resistance
primarily during inspiration with resulting adverse physiological
consequences. Thus, our invention also contemplates applying
elevated pressure only during inhalation thus eliminating the need
for global (inhalation and exhalation) increases in airway
pressure. The relatively lower pressure applied during expiration
may in some cases approach or equal ambient pressure. The lower
pressure applied in the airway during expiration enhances patient
tolerance by alleviating some of the uncomfortable sensations
normally associated with CPAP.
[0022] Under prior CPAP therapy, pressures as high as 20 cm H20
have been required, and some patients on nasal CPAP thus have been
needlessly exposed to unnecessarily high expiratory pressures with
the attendant discomfort and elevated mean airway pressure and
theoretic risk of barotrauma. Our invention permits independent
application of a higher inspiratory airway pressure in conjunction
with a lower expiratory airway pressure in order to provide a
therapy which is better tolerated by the 25% of the patient
population which does not tolerate CPAP therapy, and which may be
safer in the other 75% of the patient population.
[0023] As has been noted hereinabove, the switch between higher and
lower pressure magnitudes can be controlled by spontaneous patient
respiration, and the patient thus is able to independently govern
respiration rate and volume. As has been also noted, the invention
contemplates automatic compensation for system leakage whereby
nasal mask fit and air flow system integrity are of less
consequence than in the prior art. In addition to the benefit of
automatic leak compensation, other important benefits of the
invention include lower mean airway pressures for the patient and
enhanced safety, comfort and tolerance.
[0024] It is accordingly one object of the present invention to
provide novel and improved method for treatment of sleep apnea.
[0025] A further object of the invention is to provide a novel and
improved apparatus which is operable according to a novel
methodology in carrying out such a treatment for sleep apnea.
[0026] Another object of the invention is to provide a method and
apparatus for treating sleep apnea by application of alternately
high and low magnitudes of pressure in the airway of the patient
with the high and low pressure magnitudes being initiated by
spontaneous patient respiration.
[0027] Another object of the invention is to provide an apparatus
for generating alternately high and low pressure gas flow to a
consumer of the gas with the higher and lower pressure flows being
controlled by comparison of the instantaneous flow rate to the gas
consumer with the average flow rate to the consumer which average
flow rate may include leakage from the system, and whereby the
apparatus automatically compensates for system leakage.
[0028] These and other objects and further advantages of the
invention will be more readily appreciated upon consideration of
the following detailed description and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] FIG. 1 is a functional block diagram of an apparatus
according to the instant invention which is operable according to
the method of the instant invention;
[0030] FIG. 2 is a functional block diagram showing an alternative
embodiment of the invention;
[0031] FIG. 3 is a functional block diagram of the Estimated Leak
Computer of FIG. 2;
[0032] FIG. 4 is a frontal elevation of a control panel for the
apparatus of this invention;
[0033] FIG. 5 is a trace of patient flow rate versus time
pertaining to another embodiment of the invention;
[0034] FIG. 6 is a flow diagram relating to the embodiment of FIG.
5;
[0035] FIG. 7 is a trace of patient flow rate versus time
illustrating another embodiment of the invention;
[0036] FIG. 8 is a schematic illustration of a circuit according to
an embodiment of the invention;
[0037] FIG. 9 is a trace of flow rate versus time showing processed
and unprocessed flow rate signals;
[0038] FIGS. 10a and 10b are illustrations of the operation at
control algorithms according to other embodiments of the
invention;
[0039] FIGS. 11a and 11b are illustrations of the operation of
still other control algorithms according to other embodiments of
the invention; and
[0040] FIG. 12 illustrates operation of yet another control
algorithm according to the invention.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0041] There is generally indicated at 10 in FIG. 1 an apparatus
according to one presently preferred embodiment of the instant
invention and shown in the form of a functional block diagram.
Apparatus 10 is operable according to a novel process which is
another aspect of the instant invention for delivering breathing
gas such as air alternately at relatively higher and lower
pressures (i.e., equal to or above ambient atmospheric pressure) to
a patient 12 for treatment of the condition known as sleep
apnea.
[0042] Apparatus 10 comprises a gas flow generator 14 (e.g., a
blower) which receives breathing gas from any suitable source, a
pressurized bottle 16 or the ambient atmosphere, for example. The
gas flow from flow generator 14 is passed via a delivery conduit 20
to a breathing appliance such as a mask 22 of any suitable known
construction which is worn by patient 12. The mask 22 may
preferably be a nasal mask or a full face mask 22 as shown. Other
breathing appliances which may be used in lieu of a mask include
nasal cannulae, an endotracheal tube, or any other suitable
appliance for interfacing between a source of breathing gas and a
patient, consistent with the desired effect to be achieved through
use of the apparatus 10.
[0043] The mask 22 includes a suitable exhaust port means,
schematically indicated at 24, for exhaust of breathing gases
during expiration. Exhaust port 24 preferably is a continuously
open port which imposes suitable flow resistance upon exhaust gas
flow to permit a pressure controller 26 located in line with
conduit 20 between flow generator 14 and mask 22 to control the
pressure of air flow within conduit 20 and thus within the airway
of the patient 12. For example, exhaust port 24 may be of
sufficient cross-sectional flow area to sustain a continuous
exhaust flow of approximately 15 liters per minute. The flow via
exhaust port 24 is one component and typically the major component
of the overall system leakage, which is an important parameter of
system operation. In an alternative embodiment to be discussed
hereinbelow, it has been found that a non-rebreathing valve may be
substituted for the continuously open port 24.
[0044] The pressure controller 26 is operative to control the
pressure of breathing gas within the conduit 20 and thus within the
airway of the patient. Pressure controller 26 is located
preferably, although not necessarily, downstream of flow generator
14 and may take the form of an adjustable valve which provides a
flow path which is open to the ambient atmosphere via a restricted
opening, the valve being adjustable to maintain a constant pressure
drop across the opening for all flow rates and thus a constant
pressure within conduit 20.
[0045] Also interposed in line with conduit 20, preferably
downstream of pressure controller 26, is a suitable flow transducer
28 which generates an output signal that is fed as indicated at 29
to a flow signal conditioning circuit 30 for derivation of a signal
proportional to the instantaneous flow rate of breathing gas within
conduit 20 to the patient.
[0046] It will be appreciated that flow generator 14 is not
necessarily a positive displacement device. It may be, for example,
a blower which creates a pressure head within conduit 20 and
provides air flow only to the extent required to maintain that
pressure head in the presence of patient breathing cycles, the
exhaust opening 24, and action of pressure controller 26 as above
described. Accordingly, when the patient is exhaling, peak
exhalation flow rates from the lungs may far exceed the flow
capacity of exhaust port 24. As a result, exhalation gas backflows
within conduit 20 through flow transducer 28 and toward pressure
controller 26, and the instantaneous flow rate signal from
transducer 28 thus will vary widely within a range from relatively
large positive (i.e. toward the patient) flow to relatively large
negative (i.e. from the patient) flow.
[0047] The instantaneous flow rate signal from flow signal
conditioning circuitry 30 is fed as indicated at 32 to a decision
module 34, a known comparator circuit for example, and is
additionally fed as indicated at 36 to a low pass filter 38. Low
pass filter 38 has a cut-off frequency low enough to remove from
the instantaneous flow rate input signal most variations in the
signal which are due to normal breathing. Low pass filter 38 also
has a long enough time constant to ensure that spurious signals,
aberrant flow patterns and peak instantaneous flow rate values will
not dramatically affect system average flow. That is, the time
constant of low pass filter 38 is selected to be long enough that
it responds slowly to the instantaneous flow rate signal input.
Accordingly, most instantaneous flow rate input signals which could
have a large impact on system average flow in the short term have a
much smaller impact over a longer term, largely because such
instantaneous flow rate signal components will tend to cancel over
the longer term. For example peak instantaneous flow rate values
will tend to be alternating relatively large positive and negative
flow values corresponding to peak inhalation and exhalation flow
achieved by the patient during normal spontaneous breathing. The
output of low pass filter 38 thus is a signal which is proportional
to the average flow in the system, and this is typically a positive
flow which corresponds to average system leakage (including flow
from exhaust 24) since, as noted, inhalation and exhalation flow
cancel for all practical purposes.
[0048] The average flow signal output from the low pass filter 38
is fed as indicated at 40 to decision circuitry 34 where the
instantaneous flow rate signal is continually compared to the
system average flow signal. The output of the decision circuitry 34
is fed as a drive signal indicated at 42 to control the pressure
controller 26. The pressure magnitude of breathing gas within
conduit 20 thus is coordinated with the spontaneous breathing
effort of the patient 12 as follows.
[0049] When the patient begins to inhale, the instantaneous flow
rate signal goes to a positive value above the positive average
flow signal value. Detection of this increase in decision circuitry
34 is sensed as the start of patient inhalation. The output signal
from decision circuitry 34 is fed to pressure controller 26 which,
in response, provides higher pressure gas flow within conduit 20
and thus higher pressure within the airway of the patient 12. This
is the higher magnitude pressure value of our bi-level CPAP system
and is referred to hereinbelow as IPAP (inhalation positive airway
pressure). During inhalation, the flow rate within conduit 20 will
increase to a maxim and then decrease as inhalation comes to an
end.
[0050] At the start of exhalation, air flow into the patient's
lungs is nil and as a result the instantaneous flow rate signal
will be less than the average flow rate signal which, as noted is a
relatively constant positive flow value. The decision circuitry 34
senses this condition as the start of exhalation and provides a
drive signal to pressure controller 26 which, in response, provides
gas flow within conduit 20 at a lower pressure which is the lower
magnitude pressure value of the bi-level CPAP system, referred to
hereinbelow as EPAP (exhalation positive airway pressure). As has
been noted hereinabove the range of BiPAP pressures may include
ambient atmospheric pressure. When the patient again begins
spontaneous inhalation, the instantaneous flow rate signal again
increases over the average flow rate signal, and the decision
circuitry once again feeds a drive signal to pressure controller 26
to reinstitute the IPAP pressure.
[0051] System operation as above specified requires at least
periodic comparison of the input signals 32 and 40 by decision
circuitry 34. Where this or other operations are described herein
as continual, the scope of meaning to be ascribed includes both
continuous (i.e. uninterrupted) and periodic (i.e. at discrete
intervals).
[0052] As has been noted, the system 10 has a built-in controlled
leakage via exhaust port 24 thus assuring that the average flow
signal normally will be at least a small positive flow, although in
some circumstances such as when oxygen is added to the gas flow,
the average flow may be a negative value. During inhalation, the
flow sensed by the flow transducer will be the sum of exhaust flow
via port 24 and all other system leakage downstream of transducer
28, and inhalation flow within the airway of the patient 12.
Accordingly, during inhalation the instantaneous flow rate signal
as conditioned by conditioning module 30, will reliably and
consistently reflect inhalation flow exceeding the average flow
rate signal. During exhalation, the flow within conduit 20 reverses
as exhalation flow from the lungs of the patient far exceeds the
flow capacity of exhaust port 24. Accordingly, exhalation air
backflows within conduit 20 past transducer 28 toward pressure
controller 26. Since pressure controller 26 is operable to maintain
set pressure, it will act in response to flow coming from both the
patient and the flow generator to open an outlet port sufficiently
to accommodate the additional flow and thereby maintain the
specified set pressure as determined by action of decision
circuitry 34.
[0053] In both the inhalation and exhalation cycle phases, the
pressure of the gas within conduit 20 exerts a pressure within the
airway of the patient to maintain an open airway and thereby
alleviate airway constriction.
[0054] In practice, it may be desirable to provide a light offset
in the switching level within decision circuitry 34 with respect to
the average flow rate signal, so that the system does not
prematurely switch from the low pressure exhalation mode to the
higher pressure inhalation mode. That is, switching setpoint offset
in the positive direction from system average flow may be provided
such that the system will not switch to the IPAP mode until the
patient actually exerts a significant spontaneous inspiratory
effort of a minimum predetermined magnitude. This will ensure that
the initiation of inhalation is completely spontaneous and not
forced by an artificial increase in airway pressure. A similar
switching setpoint offset may be provided when in the IPAP mode to
ensure the transition to the lower pressure EPAP mode will occur
before the flow rate of air into the lungs of the patient reaches
zero (i.e. the switch to EPAP occurs slightly before the patient
ceases inhalation.) This will ensure that the patient will
encounter no undue initial resistance to spontaneous
exhalation.
[0055] From the above description, it will be seen that a novel
method of treating sleep apnea is proposed according to which the
airway pressure of the patient is maintained at a higher positive
pressure during inspiration and a relatively lower pressure during
expiration, all without interference with the spontaneous breathing
of the patient. The described apparatus is operable to provide such
treatment for sleep apnea patients by providing a flow of breathing
gas to the patient at positive pressure, and varying the pressure
of the air flow to provide alternately high and low pressure within
the airway of the patient coordinated with the patient's
spontaneous inhalation and exhalation. The described system can
also be used with pressure support systems such as the proportional
airway pressure system described in U.S. Pat. No. 5,107,830 to
Younes, the entire disclosure of which is hereby incorporated
herein and made a part hereof by reference.
[0056] To provide pressure control, the flow rate of breathing gas
to the patient is detected and processed to continually provide a
signal which is proportional to the instantaneous breathing gas
flow rate in the system. The instantaneous flow rate signal is
further processed to eliminate variations attributable to normal
patient respiration and other causes thus generating a signal which
is proportional to the average or steady state system gas flow. The
average flow signal is continually compared with the instantaneous
flow signal as a means to detect the state of the patient's
spontaneous breathing versus average system flow. When
instantaneous flow exceeds the average flow, the patient is
inhaling, and in response the pressure of gas flowing to the
patient is set at a selected positive pressure, to provide a
corresponding positive pressure within the airway of the patient.
When comparison of the instantaneous flow rate signal with the
average flow signal indicates the patient is exhaling, as for
example when the instantaneous flow signal indicates flow equal to
or less than the average flow, the pressure of breathing gas to the
patient is adjusted to selected lower pressure to provide a
corresponding lower pressure within the airway of the patient.
[0057] In an alternative embodiment of the invention as shown in
FIGS. 2 and 3, the low pass filter 38 is replaced by an estimated
leak computer which includes a low pass filter as well as other
functional elements as shown in FIG. 3. The remainder of the system
as shown in FIG. 2 is similar in most respects to the system shown
in FIG. 1. Accordingly, like elements are identified by like
numbers, and the description hereinabove of FIG. 1 embodiment also
applies generally to FIG. 2.
[0058] By using the operative capability of the estimated leak
computer 50, as described hereinbelow, it is possible to adjust the
reference signal which is fed to decision circuitry 34 on a breath
by breath basis rather than merely relying on a long term average
system flow. To distinguish this new reference signal form average
system flow it will be referred to hereinbelow as the estimated
leak flow rate signal or just the estimated leak signal.
[0059] As was noted hereinabove, the average system flow rate
reference signal changes very slowly due to the long time constant
of the low pass filter 38. This operative feature was intentionally
incorporated to avoid disturbance of the reference signal by
aberrant instantaneous flow rate signal inputs such as erratic
breathing patterns. While it was possible to minimize the impact of
such aberrations on the average flow rate reference signal, the
average flow signal did nevertheless change, although by small
increments and only very slowly in response to disturbances. Due to
the long time constant of the low pass filter, such changes in the
reference signal even if transitory could last for a long time.
[0060] Additionally, even a small change in the reference signal
could produce a very significant effect on system triggering. For
example, since the objective is to trigger the system to the IPAP
mode when inhalation flow just beings to go positive, small changes
in the reference signal could result in relatively large changes in
the breathing effort needed to trigger the system to the IPAP mode.
In some instances the change in reference signal could be so great
that with normal breathing effort the patient would be unable to
trigger the system. For example, if the system were turned on
before placement of the mask on the face of the patient, the
initial free flow of air from the unattached mask could result in a
very large magnitude positive value for initial average system
flow. If such value were to exceed the maximum inspiratory flow
rate achieved in spontaneous respiration by the patient, the system
would never trigger between the IPAP and EPAP modes because the
decision circuitry would never see an instantaneous flow rate
signal greater than the average flow rate signal, at least not
until a sufficient number of normal breathing cycles after
application of the mask to the patient to bring the reference
signal down to a value more closely commensurate with the actual
system leak in operation. As has been noted, with the low pass
filter this could take a rather long time, during which time the
patient would be breathing spontaneously against a uniform positive
pressure. This would not be at all in keeping with the present
invention.
[0061] In addition to the embodiment based on a reference signal
derived from estimated leak flow rate on a breath by breath basis
which is controlled totally by spontaneous patient breathing, two
further modes of operation also are envisioned, one being
spontaneous/timed operation in which the system automatically
triggers to the IPAP mode for just long enough to initiate patient
inspiration if the system does not sense inspiratory effort within
a selected time after exhalation begins. To accomplish this, a
timer is provided which is reset at the beginning of each patient
inspiration whether the inspiratory cycle was triggered
spontaneously or by the timer itself. Thus, only the start of
inspiration is initiated by the timer. The rest of the operating
cycle in this mode is controlled by spontaneous patient breathing
and the circuitry of the system to be described.
[0062] A further mode of operation is based purely on timed
operation of the system rather than on spontaneous patient
breathing effort, but with timed cycles in place of spontaneous
patient breathing.
[0063] Referring to FIG. 3, the estimated leak computer 50 includes
the low pass filter 38' as well as other circuits which are
operative to make corrections to the estimated leak flow rate
signal based on on-going analysis of each patient breath. A further
circuit is provided which is operative to adjust the estimated leak
flow rate signal quickly after major changes in system flow such as
when the blower has been running prior to the time when the mask is
first put on the patient, or after a major leak in the system has
either started or has been shut off.
[0064] The low pass filter 38' also includes a data storage
capability whose function will be described hereinbelow.
[0065] The low pass filter 38' operates substantially as described
above with reference to FIG. 1 in that it provides a long term
average of system flow which is commensurate with steady state
system leakage including the flow capacity of the exhaust port 24.
This long term average is operative in the FIG. 3 embodiment to
adjust the estimated leak flow rate reference signal only when
system flow conditions are changing very slowly.
[0066] To provide breath by breath analysis and adjustment of the
reference signal, a differential amplifier 52 receives the
instantaneous flow rate signal as indicated at 54, and the
estimated leak signal output from low pass filter 38' as indicated
at 56.
[0067] The output of differential amplifier 52 is the difference
between instantaneous flow rate and estimated leak flow rate, or in
other words estimated instantaneous patient flow rate. This will be
clear upon considering that instantaneous flow is the sum of
patient flow plus actual system leakage. The estimated patient flow
signal output from differential amplifier 52 is provided as
indicated at 58 to a flow integrator 60 which integrates estimated
patient flow breath by breath beginning and ending with the trigger
to IPAP. Accordingly, an additional input to the flow integrator 60
is the IPAP/EPAP state signal as indicated at 62. The IPAP/EPAP
state signal is the same as the drive signal provided to pressure
controller 26; that is it is a signal indicative of the pressure
state, as between IPAP and EPAP, of the system. The state signal
thus may be used to mark the beginning and end of each breath for
purposes of breath by breath integration by integrator 60.
[0068] If the estimated leak flow rate signal from low pass filter
38' is equal to the true system leak flow rate, and if the
patient's inhaled and exhaled volumes are identical for a given
breath (i.e. total positive patient flow equals total negative
patient flow for a given breath), then the integral calculated by
integrator 60 will be zero and no adjustment of estimated leak flow
rate will result. When the integral calculated by integrator 60 is
non-zero, the integral value in the form of an output signal from
integrator 60 is provided as indicated at 64 to a sample to hold
module 66. Of course, even with a zero value integral, an output
signal may be provided to module 66, but the ultimate result will
be no adjustment of the estimated leak flow rate signal.
[0069] A non-zero integral value provided to module 66 is further
provided to module 38' as indicated at 68 with each patient breath
by operative action of the IPAP/EPAP state signal upon module 66 as
indicated at 70. The effect of a non-zero integral value provided
to module 38' is an adjustment of the estimated leak flow rate
signal proportional to the integral value and in the direction
which would reduce the integral value towards zero on the next
breath if all other conditions remain the same.
[0070] With this system, if the patient's not breathing cycle
volume is zero, and if the system leak flow rate changes, the
integrator circuit will compensate for the change in leak flow rate
by incremental adjustments to the estimated leak flow rate within
several patient breaths.
[0071] The integrator circuit 60 also will adjust the estimated
leak flow rate signal in response to non-zero net volume in a
patient breathing cycle. It is not unusual for a patient's
breathing volume to be non-zero. For example, a patient may inhale
slightly more on each breath than he exhales over several breathing
cycles, and then follow with a deeper of fuller exhalation. In this
case, the integrator circuit would adjust the estimated leak flow
rate signal as if the actual system leak rate had changed; however,
since the reference signal correction is only about one tenth as
large as would be required to make the total correction in one
breath, the reference signal will not change appreciably over just
one or two breaths. Thus, the integrator circuit accommodates both
changes in system leakage and normal variations in patient
breathing patterns.
[0072] An end exhalation module 74 is operative to calculate
another data component for use in estimating the system leak flow
rate as follows. The module 74 monitors the slope of the
instantaneous flow rate wave form. When the slope value is near
zero during exhalation (as indicated by the state signal input 76)
the indication is that the flow rate is not changing. If the slope
of the instantaneous flow rate signal wave form remains small after
more than one second into the respiratory phase, the indication is
that exhalation has ended and that the net flow rate at the point
thus is the leak flow rate. However, if estimated patient flow rate
is non-zero at the same time, one component of the instantaneous
flow rate signal must be patient flow.
[0073] When these conditions are met, the circuit adjusts the
estimated leak flow rate slowly in a direction to move estimated
patient flow rate toward zero to conform to instantaneous patient
flow conditions expected at the end of exhalation. The adjustment
to estimated leak flow rate is provided as an output from module 74
to low pass filter 38' as indicated at 80. When this control
mechanism takes effect, it disables the breath by breath volume
correction capability of integrator circuit 60 for that breath
only.
[0074] The output of module 74 is a time constant control signal
which is provided to low pass filter 38' to temporarily shorten the
time constant thereof for a sufficient period to allow the
estimated leak flow rate to approach the instantaneous flow rate
signal at that specific instant. It will be noted that shortening
the low pass filter time constant increases the rapidity with which
the low pass filter output (a system average) can adjust toward the
instantaneous flow rate signal input.
[0075] Another component of estimated leak flow rate control is a
gross error detector 82 which acts when the estimated patient flow
rate, provided thereto as indicated at 84, is away from zero for
more than about 5 seconds. Such a condition may normally occur, for
example, when the flow generator 14 is running before mask 22 is
applied to the patient. This part of the control system is
operative to stabilize operation quickly after major changes in the
leak rate occur.
[0076] In accordance with the above description, it will be seen
that low pass filter 38' acts on the instantaneous flow rate signal
to provide an output corresponding to average system flow, which is
system leakage since patient inspiration and expiration over time
constitutes a net positive flow of zero With other enhancements, as
described, the system average flow can be viewed as an estimate of
leakage flow rate.
[0077] The differential amplifier 52 processes the instantaneous
flow rate signal and the estimated leak flow rate signal to provide
an estimated patient flow rate signal which is integrated and
non-zero values of the integral are fed back to module 38' to
adjust the estimated leak flow rate signal on a breath by breath
basis. The integrator 60 is reset by the IPAP/EPAP state signal via
connection 62.
[0078] Two circuits are provided which can override the integrator
circuit, including end exhalation detector 74 which provides an
output to adjust the time constant of low pass filter 38' and which
also is provided as indicated at 86 to reset integrator 60. Gross
error detector 82 is also provided to process estimated patient
flow rate and to provide an adjustment to estimated leak flow rate
under conditions as specified. The output of module 82 also is
utilized as an integrator reset signal as indicated at 86. It will
be noted that the integrator 60 is reset with each breath of the
patient if, during that breath, it is ultimately overridden by
module 74 or 82. Accordingly, the multiple reset capabilities for
integrator 60 as described are required.
[0079] In operation, the system may be utilized in a spontaneous
triggering mode, a spontaneous/timed mode or a purely timed mode of
operation. In spontaneous operation, decision circuitry 34
continuously compares the instantaneous flow rate exceeds estimated
leak flow rate by approximately 4 cc per second. When this
transition occurs, decision circuitry 34 triggers the system into
the IPAP mode for 150 milliseconds. The system will then normally
remain in the IPAP mode as the instantaneous flow rate to the
patient will continue to increase during inhalation due to
spontaneous patient effort and the assistance of the increased IPAP
pressure.
[0080] After the transition to the IPAP mode in each breath, a
temporary offset is added to the estimated leak flow rate reference
signal. The offset is proportional to the integral of estimated
patient flow rate beginning at initiation of the inspiratory breath
so that it gradually increases with time during inspiration at a
rate proportional to the patient's inspiratory flow rate.
Accordingly, the flow rate level above estimated leak flow needed
to keep the system in the IPAP mode during inhalation decreases
with time from the beginning of the inhalation and in proportion to
the inspiratory flow rate. With this enhancement, the longer an
inhalation cycle continues, the larger is the reference signal
below which instantaneous flow would have to decrease in order to
trigger the EPAP mode. For example, if a patient inhales as a
constant 500 cc per second until near the end of inspiration, a
transition to EPAP will occur when his flow rate drops to about 167
cc per second after one second, or 333 cc per second after two
seconds, or 500 cc per second after three seconds, and so forth.
For a patient inhaling at a constant 250 cc per second, the
triggers would occur at 83, 167 and 250 cc per second and one, two
and three seconds into IPAP, respectively.
[0081] In this way, the EPAP trigger threshold comes up to meet the
inspiratory flow rate with the following benefits. First, it
becomes easier and easier to end the inspiration cycle with
increasing time into the cycle. Second, if a leak develops which
causes an increase in instantaneous flow sufficient to trigger the
system into the IPAP mode, this system will automatically trigger
back to the EPAP mode after about 3.0 seconds regardless of patient
breathing effort. This would allow the volume-based leak correction
circuit (i.e. integrator 60) to act as it is activated with each
transition to the IPAP mode. Thus, if a leak develops suddenly,
there will be a tendency toward automatic triggering rather than
spontaneous operation for a few breaths, but the circuit will not
be locked into the IPAP mode.
[0082] Upon switching back to the EPAP mode, the trigger threshold
will remain above the estimated leak flow rate for approximately
500 milliseconds to allow the system to remain stable in the EPAP
mode without switching again while the respective flow rates are
changing. After 500 milliseconds, the trigger threshold offset is
reset to zero to await the next inspiratory effort.
[0083] The normal state for the circuit is for it to remain in the
EPAP mode until an inspiratory effort is made by the patient. The
automatic corrections and adjustments to the reference signal are
effective to keep the system from locking up in the IPAP mode and
to prevent auto-triggering while at the same time providing a high
level of sensitivity to inspiratory effort and rapid adjustment for
changing leak conditions and breathing patterns.
[0084] In the spontaneous/timed mode of operation, the system
performs exactly as above described with reference to spontaneous
operation, except that it allows selection of a minimum breathing
rate to be superimposed upon the spontaneous operating mode. If the
patient does not make an inspiratory effort within a predetermined
time, the system will automatically trigger to the IPAP mode for
200 milliseconds. The increased airway pressure for this 200
milliseconds will initiate patient inspiration and provide
sufficient time that spontaneous patient flow will exceed the
reference signal so that the rest of the cycle may continue in the
spontaneous mode as above described. The breaths per minute timer
is reset by each trigger to IPAP whether the transition was
triggered by the patient or by the timer itself.
[0085] In the timed operating mode, all triggering between IPAP and
EPAP modes is controlled by a timer with a breaths per minute
control being used to select a desired breathing rate from, for
example, 3 to 30 breaths per minute. If feasible, the selected
breathing rate is coordinated to the patient's spontaneous
breathing rate. The percent IPAP control is used to set the
fraction of each breathing cycle to be spent in the IPAP mode. For
example, if the breaths per minute control is set to 10 breaths per
minute (6 seconds per breath) and the percent IPAP control is set
to 33%, then the flow generator will spend, in each breathing
cycle, two seconds in IPAP and four seconds in EPAP.
[0086] FIG. 4 illustrates a control panel for controlling the
system above described and including a function selector switch
which includes function settings for the three operating modes of
spontaneous, spontaneous/timed, and timed as above described. The
controls for spontaneous mode operation include IPAP and EPAP
pressure adjustment controls 90 and 92, respectively. These are
used for setting the respective IPAP and EPAP pressure levels. In
the spontaneous/timed mode of operation, controls 90 and 92 are
utilized as before to set IPAP and EPAP pressure levels, and
breaths per minute control 94 additionally is used to set the
minimum desired breathing rate in breaths per minute. In the timed
mode of operation, control 96 is used to set the time percentage of
each breath to be spent in the IPAP mode.
[0087] Lighted indicators such as LED's 96, 98 and 100 are also
provided to indicate whether the system is in the IPAP or EPAP
state, and to indicate whether in the spontaneous/timed mode of
operation the instantaneous state of the system is spontaneous
operation or timed operation.
[0088] An alternative embodiment of the invention contemplates
detecting the beginning of inspiration and expiration by reference
to a patient flow rate wave form such as shown in FIG. 5.
Comparison of instantaneous flow rate with average flow rate as set
forth hereinabove provides a satisfactory method for determining
whether a patient is inhaling or exhaling; however, other means for
evaluating instantaneous flow rate can also be used and these may
be used alone or in combination with average flow rate.
[0089] For example, FIG. 5 shows a typical patient flow rate wave
form with inspiration or inhalation flow shown as positive flow
above base line B and exhalation flow shown as negative flow below
base line B. The flow rate wave form may thus be sampled at
discrete time intervals. The current sample is compared with that
taken at an earlier time. This approach appears to offer the
benefit of higher sensitivity to patient breathing effort in that
it exhibits less sensitivity to errors in the estimated system
leakage, as discussed hereinabove.
[0090] Normally, the estimated inspiratory and expiratory flow rate
wave forms will change slowly during the period beginning after a
few hundred milliseconds into the respective inspiratory and
expiratory phases, up until the respective phase is about the end.
Samples of the flow rate wave form are taken periodically, and the
current sample is compared repeatedly with a previous sample.
During inspiration, if the magnitude of the current sample is less
than some appropriate fraction of the comparison sample, then the
inspiration phase is deemed to be finished. This condition thus can
be used to trigger a change to the desired exhalation phase
pressure, the same process can be used during exhalation to provide
a trigger condition for the changeover to inhalation pressure.
[0091] FIG. 6 illustrates a flow diagram for a suitable algorithm
showing repeated sampling of the patient flow rate wave form at
time intervals .DELTA.t, as shown at 110, and repeated comparison
of the flow at current time t with a prior sampling, for example
the flow at time t-4 as indicated at 112. Of course, the time
increment between successive samplings is small enough that the
comparison with the value observed in the fourth prior sampling
event covers a suitably small portion of the flow rate wave form.
For example, as shown in FIG. 5 the designations for flow sampled
at time t, the sample value taken four sampling events prior at
time t-4, and the time interval .DELTA.t illustrate one suitable
proportionate relationship between .DELTA.t and the time duration
of a patient breath. This is, however, only an illustration. In
fact, electronic technology such as disclosed hereinabove would be
capable of performing this algorithm using much smaller .DELTA.t
intervals, provided other parameters of the algorithm, such as the
identity of the comparison sample and/or the proportion
relationship between the compared samples, are adjusted
accordingly.
[0092] Continuing through the flow chart of FIG. 6, if the
patient's state of breathing is inspiration (114), the current flow
sample value is compared with the sample value observed t-4
sampling events prior. If the current flow sample value is less
than, for example, 75% of the comparison flow value (116), the
system triggers a change in state to the exhalation phase (118). If
the current flow sample value is not less than 75% of the
comparison value (120), no change in breathing state is
triggered.
[0093] If the breathing state is not inspiration, and the current
flow sample value is less than 75% of the selected comparison value
(122), then an expiration phase, rather than an inspiration phase,
is completed and the system is triggered to change the state of
breathing to inspiration (124). If the specified flow condition is
not met, again no change in breathing phase is triggered (126).
[0094] The routine characterized by FIG. 6 repeats continuously as
indicated at 128, each time comparing a current flow sample with
the fourth (or other suitable) prior sample to determine whether
the system should trigger from one breathing phase to the
other.
[0095] Of course, it will be understood that the embodiment set
forth above with reference to FIGS. 5 and 6 does not trigger
changes in breathing per se within the context of the invention as
set forth in the balance of the above specification. Rather, in
that context the FIGS. 5 and 6 embodiment merely detects changes
between inspiration and expiration in spontaneous patient
breathing, and triggers the system to supply the specified higher
or lower airway pressure as set forth hereinabove.
[0096] Common problems resulting from insufficient ventilator
triggering sensitivity include failure of the ventilator to trigger
to IPAP upon exertion of inspiratory effort by the patient, and
failure of the ventilator in IPAP to trigger off or to EPAP at the
end of patient inspiratory effort. Patient respiratory effort
relates primarily to the inspiratory portion of the respiration
cycle because in general only the inspiratory part of the cycle
involves active effort. The expiratory portion of the respiration
cycle generally is passive. A further characteristic of the
respiratory cycle is that expiratory flow rate generally may reach
zero and remain at zero momentarily before the next inspiratory
phase begins. Therefore the normal stable state for a
patient-triggered ventilator should be the expiratory state, which
is referred to herein as EPAP.
[0097] Although the apparatus as above described provides sensitive
triggering between the IPAP and EPAP modes, triggering can be still
further improved. The primary objectives of improvements in
triggering sensitivity generally are to decrease the tendency of a
system to trigger automatically from EPAP to IPAP in the absence of
inspiratory effort by the patient, and to increase system
sensitivity to the end of patient inspiratory effort. These are not
contradictory objectives. Decreasing auto-trigger sensitivity does
not necessarily also decrease triggering sensitivity to patient
effort.
[0098] Generally, for a patient whose ventilatory drive is
functioning normally, the ideal ventilatory triggering sensitivity
is represented by close synchronization between changes of state in
the patient's respiration (between inspiration and expiration), and
the corresponding changes of state by the ventilator. Many
conventional pressure support ventilators which trigger on the
basis of specified flow or pressure thresholds can approach such
close synchronization only under limited conditions.
[0099] In the system described hereinabove, where triggering is
based on specified levels of estimated patient flow rate, close
synchronization between system state changes and patient
respiration state changes can be readily achieved. This is
especially true for patients having no severe expiratory flow
limitation as the flow rate reversals for such patients typically
may correspond quite closely with changes in the patient
respiratory effort; however, flow rate reversals may not
necessarily correspond precisely to changes in patient respiratory
effort for all patients. For example, those patients experiencing
respiratory distress or those being ventilated with pressure
support ventilation may not exhibit the desired close
correspondence between patient effort and breathing gas supply flow
rate reversals.
[0100] In addressing improvements in synchronized triggering based
on flow rate, at least three different respiratory cycles are
considered. The first is the patient respiratory cycle as indicated
by patient effort. If the patient makes any effort, it must include
inspiratory effort. Patient expiration may be active or
passive.
[0101] The second cycle is the ventilator respiratory cycle, that
is, the cycle delivered by the ventilator. This cycle also has an
inspiratory phase and an expiratory phase, but the ventilator may
or may not be synchronized with the corresponding phases of the
patient respiratory cycle.
[0102] The third cycle is the flow respiratory cycle, as indicated
by the direction of flow to or from the patient's airway. Flow
passes from the ventilator into the patient on inspiration and out
of the patient on expiration. If one looks at this cycle only, the
inspiratory/expiratory changes could be identified by the zero flow
crossings between positive and negative flow.
[0103] Ideally, if the patient's breathing drive is competent, the
flow respiratory cycle should be synchronized with the patient
respiratory cycle, with the assistance of the ventilator. One
important objective of the triggering described here is to
synchronize the ventilator cycle with the patient cycle so that the
flow cycle is coordinated with patient inspiratory effort. With
flow triggering the pressure delivered by the ventilator affects
the flow, in addition to the effect on flow of the patient's own
efforts. This is another reason why zero flow crossings may not
necessarily be good indicators of changes in patient effort.
[0104] As described, flow triggering provides certain advantages
not available with some other modes of ventilator triggering. For
example in ventilators which use pressure variation for triggering,
when the patient makes an inspiratory effort lung volume begins to
increase. This volume change causes a pressure drop, which in some
conventional closed circuit ventilators is sensed by the ventilator
triggering system to initiate breathing gas delivery. With flow
triggering there is no need for a pressure drop to occur in the
breathing circuit. The triggering algorithm may still require the
patient lung volume to increase, but since the pressure in the
ventilator circuit does not have to drop the patient expends less
energy in the inspiratory effort to achieve a given volume
change.
[0105] Additionally, in an open circuit, that is one in which
exhaled gases are flushed from the system via a fixed leak, it
would be difficult to generate the required pressure drop for
pressure based triggering upon exertion of small patient
inspiratory effort. That is, with an open circuit the magnitude of
patient effort required to generate even a very small pressure drop
would be considerable. Thus, It would be correspondingly quite
difficult to achieve sufficient sensitivity in a pressure based
triggering system to provide reliable triggering if used in
conjunction with an open circuit. In general, the open circuit is
simpler than one with a separate exhaust valve and exhaust tubing
and therefore simpler to use and less costly, and for these and
other reasons may often be preferred over a closed circuit.
[0106] In a presently preferred triggering scheme for the above
described flow rate triggering system, the flow rate signal must
exceed a threshold value equivalent to 40 cc per second
continuously for 35 milliseconds in order to trigger the system to
IPAP. If the flow rate signal drops below the specified threshold
value during the specified time interval, the threshold timer is
reset to zero. These threshold values permit triggering with a
minimal patient volume change of only 1.4 cc, which represents much
improved sensitivity over some prior pressure triggered
ventilators.
[0107] In reality, however, such minimal patient volume change
represents overly sensitive triggering which would not be practical
in actual practice. Noise in the flow rate signal would continually
reset the threshold timer during intervals when the patient flow
rate is very close to 40 cc per second. Therefore, it is believed a
minimum volume change for consistent triggering of the described
system would be about 3 cc., although this too is considered to be
a very sensitive triggering level. It is noted, however, that
pressure signal noise can also occur in prior pressure triggered
ventilators, thus creating triggering sensitivity problems. Due to
this and other details of their operation the theoretical maximum
sensitivity of such prior ventilators is better than the
sensitivity which can actually be achieved in operation.
[0108] As one example of an operating detail which can adversely
affect sensitivity in prior ventilators, if the ventilator response
time is slow, the resulting time delay between the time when a
triggering time requirement is satisfied and the time when gas
supply pressure actually begins to rise will adversely affect
sensitivity. During the time delay, the patient is continuing to
make inspiratory effort and thus will be doing much greater actual
work than that needed to trigger the ventilator, and much greater
work than would be done if the ventilator responded more quickly.
Another example occurs during rapid breathing when a patient begins
to make an inspiratory effort before exhalation flow rate drops to
zero. In this case, an additional delay occurs until flow reverses
and the exhalation valve has time to close.
[0109] Triggering to EPAP upon exhalation also can present
problems. A typical prior pressure support ventilator will trigger
off at the end of inspiration based on the patient's flow
decreasing past a flow threshold, or on timing out of a timer, for
example. The trigger-to-exhalation flow threshold can be either a
fixed value or a fraction of peak flow, for example 25% of peak
flow. As one example of the sort of problem which can affect
triggering to exhalation in prior ventilators, a patient with
moderately severe COPD (chronic obstructive pulmonary disease) will
exhibit comparatively high respiratory system resistance and
perhaps low respiratory system elastance. This will result in a
comparatively long time constant for the patient, the time constant
being the time taken for exhalation flow to decay to 1/4 of peak
flow or other suitable selected proportion of peak flow. The long
time constant for the COPD patient means that flow will drop slowly
during inspiration.
[0110] The only way this patient will be able to trigger the
ventilator to exhalation will be to increase exhalatory effort.
This is, the patient must actively decrease the flow rate by
respiratory muscle effort to trigger to exhalation. Further,
because of the patient's large time constant, there may be
considerable exhalation flow when the patient's inspiratory cycle
begins, and the trigger to IPAP thus will be delayed, to the
detriment of ventilatory sensitivity.
[0111] To achieve greater sensitivity to patient effort in an
improved embodiment of the invention, the disclosed system may be
provided with apparatus to continually monitor multiple conditions
rather than monitoring only a single condition as represented by
the above description pertinent to element 82. In the improved
embodiment, inspiratory time is limited to no more than about 3
seconds under normal conditions, and normal exhalation flow rate is
required to be nearly zero by about 5 seconds after the beginning
of exhalation.
[0112] To employ the first of these conditions the system monitors
estimated patient flow rate and requires its value to cross zero at
least once approximately every 5 seconds. To monitor this
condition, an input is required from the output of a comparator
which compares patient flow rate with zero value. The comparator is
a bistable device which provides one output (i.e. true) when
patient flow is greater than zero, and an alternative output (i.e.
false) when patient flow is less than zero. If the comparator
output is either true or false continuously for longer than about 5
seconds, a signal is generated which triggers the system to
EPAP.
[0113] The second condition is the monitoring of the IPAP/EPAP
state to see if it remains in EPAP for more than about 5 seconds.
If it does, the volume will be held at zero until there is another
valid trigger to IPAP. This function prevents the volume signal
from drifting away from zero when there is a apnea. After 5 seconds
in EPAP volume should normally be zero.
[0114] Further improvements in triggering sensitivity require
consideration of more than flow rate levels for determination of
suitable triggering thresholds. In particular, changes in the shape
or slope of the patient's flow rate wave form can be utilized to
better synchronize a ventilation system with spontaneous
respiratory effort exerted by the patient. Some such considerations
are discussed hereinabove with reference to FIGS. 5 and 6.
[0115] A typical flow rate tracing for a normal patient
experiencing relaxed breathing is shown in FIG. 7. The simplest
approach for synchronizing ventilator triggering to spontaneous
patient respiration has often been to use the zero flow points 129
as the reference for triggering between EPAP and IPAP; however,
this approach does not address the potential problems. First, as
noted above, flow rate reversals may not necessarily correspond to
changes in patient spontaneous breathing effort for all patients.
Second, the flow signal is not necessarily uniform. Concerning this
problem in particular, small flow variations corresponding to noise
in electronic signals will occur due to random variations in system
and airway pressure caused by flow turbulence or random variations
in the pressure control system. Additional flow rate noise results
from small oscillations in the breathing gas flow rate due to
changes in blood volume within the patient's chest cavity with each
heart beat. Third, since pressure support commonly is an
all-or-nothing mode of ventilation, and since the respiratory
systems of all patients will exhibit an elastance component, an
inappropriate trigger to IPAP will always result in delivery of
some volume of breathing gas unless the patient's airway is
completely obstructed. Thus, reliance on zero flow or flow
reversals for triggering will in many instances result in loss of
synchronization between a patient inspiratory effort and ventilator
delivery of breathing gas.
[0116] Referring to FIG. 7, there is shown a flow rate versus time
trace for the respiratory flow of a typical, spontaneously
breathing person. Time advances from left to right on the
horizontal axis and flow rate varies about a zero-value base line
on the vertical axis. Of course, in the description below referring
to FIG. 7 it is to be understood that the illustrated flow rate
versus time trace is an analog for spontaneous breathing by a
patient and for any detectors or sensors, whether based on
mechanical, electronic or other apparatus, for detecting patient
flow rate as a function of time.
[0117] It will be noted on reference to FIG. 7 that relatively
sharp breaks or slope changes occur in the flow rate trace with
patient inhalation effort begins and ends. Thus, although the slope
of the flow rate trace may vary widely from patient to patient
depending on the patient resistance and elastance, for any given
patient it will tend to be relatively constant during inhalation
and exhalation. The relatively sudden increase in flow trace slope
when an inspiratory effort begins, and a corresponding sudden
decrease in slope when inspiratory effort ends, can be used to
identify IPAP and EPAP trigger points. Since the abrupt changes in
flow trace slope at the beginning and end of inhalation correspond
with the beginning and end of inspiratory effort, the flow trace
slope or shape may be used to trigger the system between the IPAP
and EPAP state in reliance on changes in patient effort rather than
on relatively fixed flow thresholds.
[0118] The basic algorithm for operation of this further improved
triggering system is as follows. The input to the system is the
current flow rate at any point on the flow trace, for example point
130 in FIG. 7. The flow value is differentiated to get the
corresponding current slope 132 of the flow function at time T. Of
course, the slope corresponds to the instantaneous rate of change
of flow rate.
[0119] The slope 132 is scaled by a time factor .DELTA.t, and is
then added to the current flow value. This gives a prediction of
the flow 134 at a future time t+.DELTA.t, based on the current
slope 132 of the flow trace. As noted, the magnitude of time
interval .DELTA.t is determined by the selected scale factor by
which slope 132 is scaled. The resulting flow prediction 134
assumes, effectively, a uniform rate of change for the flow
throughout the period .DELTA.t. It will be understood that in FIG.
7 the magnitude of time intervals .DELTA.t is exaggerated, and is
different for the end of inspiration and beginning of inspiration
changes, to facilitate clear illustration. In practice, .DELTA.t
may be approximately 300 milliseconds, for example.
[0120] The accuracy of the predicted future flow rate value 134
will depend upon the actual, varying slope of the flow trace during
time interval .DELTA.t as compared to the presumed uniform slope
132. To the extent that the flow trace during interval .DELTA.t
deviates from slope 132, the actual flow value 136 at the end of
time interval .DELTA.t will vary from the predicted flow value 134.
Accordingly, it may be seen that the effectiveness of this
algorithm depends upon the actual deviation in the flow trace from
slope 132 during any given .DELTA.t time interval being small
except when the patient makes a significant change in respiratory
effort.
[0121] To further modify the predicted flow 134, an offset factor
may be added to it to produce an offset predicted value 138. The
offset is negative during inspiration so that the predicted flow at
time t+.DELTA.t will be held below the actual flow at t+.DELTA.t
except when the flow trace changes in the decreasing flow
direction, such as would occur at the end of inspiration when
patient effort ceases or even reverses.
[0122] The above description refers to an end-of-inspiration
trigger to EPAP. In an entirely similar fashion, as indicated
generally at 140 in FIG. 7, a trigger to IPAP can be governed by
prediction of a future flow rate based on differentiation of an
instantaneous flow rate 139 plus an offset factor to provide a
predicted flow rate value 142. It is noted that in this instance
the offset factor will be a positive offset since it is an abruptly
increasing flow rate that one would wish to detect. In this
instance, when actual flow rate increases sufficiently during the
.DELTA.t interval to exceed predicted value 142, for example as
indicated at 144, the system will trigger to IPAP. Thus, at any
point in the flow cycle when actual flow after a predetermined time
interval .DELTA.t differs sufficiently from the predicted, offset
flow value based on flow trace slope at time T, the system is
triggered to IPAP or EPAP depending upon the direction, either
positive or negative, in which actual flow varies from the
predicted flow.
[0123] The flow rate prediction based on current flow trace slope,
and the comparison of the predicted flow rate with actual flow rate
as described, is repeated at a high rate to generate a continuous
or nearly continuous stream of actual flow-to-predicted flow
comparisons. For example, in an analog system the process is
continuous, while in a digital system the process is repeated every
10 milliseconds or faster. In the resulting locus of predicted flow
value points, most actual-to-predicted flow comparisons do not
result in triggering because actual flow rate does not deviate
sufficiently from the predicted rate. Only at the
inspiratory-expiratory changes does this occur. The result is a
triggering method which, because it is based on flow predictions,
does not require changes in patient inspiratory effort to achieve
triggering in synchronism with spontaneous patient respirator. Of
course, the described differentiation technique of flow prediction
is but one example of a suitable flow wave shape triggering
algorithm.
[0124] A schematic diagram of one analog circuit embodying elements
of the above-described improved trigger system is shown in FIG. 8.
Input signal 146 is estimated patient flow, although it may
alternatively be total flow. Use of estimated flow, in accordance
with other aspects of the invention as described hereinabove,
allows for further improved triggering if the system includes an
unknown leak component. The input signal 146 is differentiated by
inverting differentiator 148. The diodes, switches and operational
amplifier group indicated generally at 150 are included for
practical considerations. They form a switchable polarity ideal
diode that is used to clip the large positive derivative of the
flow trace at the beginning of inspiration and the large negative
derivative at the beginning of expiration. These derivatives are
usually large, especially when ventilator pressure changes occur.
If the large derivatives are not clipped, they can interfere with
trigger circuit operation in the early part of each respiratory
phase.
[0125] The differentiated input signal is scaled by feedback
resistor 152 and input capacitor 154. These have a time constant
equal to 300 milliseconds which is a preferred delay time for the
delay portion of the circuit. The series input resistor 156 limits
high frequency noise which is outside the range of breathing
frequencies of interest. The differentiated input signal is
subtracted from the flow signal in a difference amplifier 172 since
the derivative circuit output is inverted and a sum is needed.
[0126] The requisite delay is produced using two fifth order,
switched capacitor Bessel low pass filters 158. The Bessel filter
has a linear phase shift with frequency which has the effect of
providing a time delay. Since the time delay depends on the order
of the filter as well as the frequency response, two filter
sections are needed to provide a high enough cutoff frequency with
the 300 millisecond time delay. The 300 millisecond delay was
determined experimentally. This value seems appropriate in that the
time constants for respiratory muscle activity are on the order of
50 to 100 milliseconds. Thus, a delay longer than 50 to 100
milliseconds would be needed to intercept flow changes caused by
changes in respiratory muscle activity.
[0127] A 555 type timer chip 160 is set up as a 1 kHz oscillator.
Along with the RC combination 174 at the Filter input, element 160
controls the cutoff frequency of the switched capacitor filters
158. Finally, a comparator 162 with hysteresis, provided by input
resistor 176 and feedback resistors 166 and 164, changes its state
based on the difference between the input flow rate signal and the
processed flowrate signal. There is a fixed hysteresis during the
inspiratory phase caused by resistor 166. The hysteresis
characteristic of the described circuit provides the negative
offset during inspiration and the positive offset during expiration
mentioned above.
[0128] During the expiratory phase, the hysteresis is initially
greater than that during inspiration and is based on the magnitude
of the flow signal as set by the current through resistor 164 and
diode 178. The inverting amplifier 180 has a gain of 10 so that it
saturates when the flow signal is greater than 0.5 volts, which
corresponds to a flow of 30 liters per minute. They hysteresis is
therefore almost doubled during the initial part of the exhalation
phase by virtue of the 100 k resistor 164 in parallel with the 82 k
resistor 166, in contrast with the 82 k resistor 166 acting alone
during inspiration. That is, during exhalation the output of
invertor 180 is positive. Therefore, diode 178 is forward biased
and supplies current through resistor 164 in addition to that
supplied by resistor 176.
[0129] Once the flow signal drops below the 0.5 volt level, the
hysteresis decreases linearly with flow rate to be the same as that
during inspiration. This feature prevents premature triggering to
inspiration while gradually increasing the sensitivity of the
system toward the end of exhalation. The hysteresis is somewhat
dependent on the flow signal since it is supplied through a
resistor 164. With the components described (82 k feedback resistor
166, 1.5 k input resistor 156) and a +5 volt system power supply
(not shown), the hysteresis is about 90 millivolts at zero flow.
This corresponds with a trigger offset of 90 cc per second above
the instantaneous flow signal.
[0130] FIG. 9 illustrates operation of the flow trace shape trigger
circuit with the heave line 168 indicating the flow signal at the
input and the - lighter line 170 indicating the processed flow
signal at the + input to the system comparator 162. Line 170 shows
hysteresis decreasing as flow approaches zero during
exhalation.
[0131] The triggering algorithm described immediately above is
referred to a shape triggering (i.e. relying on changes in the
shape or slope of the flow trace) to distinguish it from the flow
triggering algorithm described earlier. FIGS. 10A and 10B
illustrate the behavior of two ventilator triggering algorithms
when used in simulation of a spontaneously breathing patient with a
large respiratory time constant. In each of FIGS. 10A and 10B, the
uppermost trace represents estimated patient flow, the center trace
represents patient respiratory effort, and the bottom trace
represents ventilator pressure generated at the mask which
interfaces with the patient airway. The letter I indicates patient
inspiratory effort in each respiratory cycle.
[0132] As may be seen, FIG. 10A illustrates the sorts of triggering
problems which were described hereinabove and which have been known
to occur with actual patients. Patient inspiratory effort does not
consistently trigger the ventilator, as shown by the asynchrony
between patient effort, the estimated patient flow, and pressure
generated at the mask. FIG. 10B, by contrast, illustrates
ventilator response to the same simulated patient using the
above-described shape triggering algorithm, but with all other
settings unchanged. A comparison of FIG. 10A with 10b reveals the
improved synchronization of delivered pressure with spontaneous
patient effort.
[0133] It is noted that the simulated patient on which FIGS. 10A
and 10B are based exhibits significant exhalatory flow at the
beginning of an inspiratory effort. From FIG. 10b, it may be
clearly seen that the shape triggering algorithm triggers
appropriately at the beginning and end of each and every
inspiratory effort even though the inspiratory effort begins while
there is still exhalatory flow. Thus, the shape triggering
algorithm achieves the objective of synchronizing ventilator
triggering with changes in patient effort.
[0134] FIGS. 11A and 11B are similar to FIGS. 10A and 10B,
respectively, but the simulated patient has a shorter respiratory
system time constant. FIG. 11A illustrates, from top to bottom,
estimated patient flow, patient respiratory effort, and pressure at
the mask for a given triggering algorithm, and FIG. 11B illustrates
the same parameters for the above-described flow trace shape
triggering algorithm. In FIG. 11A it is clear that even with a
substantial drop in flow when patient effort stops, the system does
not trigger to EPAP until flow drops below about 25% of peak flow.
Thus, the end of the inspiratory phase is not synchronized with the
end of patient inspiratory effort. By contrast, the shape
triggering algorithm of FIG. 11B produces, for the same patient,
consistently synchronized triggering at the end of patient
inspiratory effort.
[0135] As may be appreciated from the above description, a
ventilator can be triggered on the basis of changes in the shape of
the flow signal which correspond to changes in patient respiratory
effort. This triggering algorithm solves several vexing problems
which have limited the utility of some prior triggering algorithms
such as standard pressure support triggering. It is also to be
noted that the described flow signal shape triggering algorithm
does not rely on any calculation of system leakage, although the
shape triggering algorithm can operate more reliably with an
estimate of system leakage than without it.
[0136] Although the described shape triggering algorithm works to
trigger both to IPAP and to EPAP, it tends to work best for
triggering to EPAP because normally a much larger and more abrupt
change in patient respiratory effort occurs at the end of
inspiration than at the beginning.
[0137] It will be noted further that the described shape triggering
algorithm may be used in parallel with the earlier described flow
triggering algorithm to provide a dual triggering system in which a
secondary triggering algorithm will function in the event the
primary algorithm malfunctions. This sort of dual triggering system
can operate on a continuing breath-to-breath basis such that at any
desired trigger point the secondary triggering algorithm will
trigger the ventilator if the primary triggering algorithm does
not.
[0138] Additional improvements in leak compensation techniques are
also contemplated by this invention. As noted in the above
description concerning leak compensation, the algorithm described
there relies on two requirements as follows: (1) the patient's
inhaled and exhaled volumes over time are the same, (and indeed if
the patient's rest volume just prior to the beginning of
inspiration is the same from breath to breath, the inhaled and
exhaled volumes for each individual breath will also be the same);
(2) when the patient is inhaling, total flow is greater than leak
flow and when the patient is exhaling total flow is les than leak
flow.
[0139] In the above description relating to leakage, only total
patient circuit flow is actually measured even though this flow is
made up of two components, patient flow and leakage flow. Further,
in the above description concerning leakage the leak is not
estimated as a function of pressure. Rather, an average leak is
calculated by integrating total flow. Since patient inhalation
volume and exhalation volume are essentially the same, the average
flow over a complete respiratory cycle is generally equal to the
average leak per cycle.
[0140] It is to be noted further that the leak component itself can
have two components, namely the known or intended leak of an
exhalation port and an unknown leak component resulting from one or
more inadvertent leaks such as leakage across a mask seal or at
tubing connection. The unknown or inadvertent leak component would
be quite difficult to determine exactly as it can be a function of
both pressure and time. Therefore, to the extent it is necessary to
determine this leak component, its value is estimated; however,
significant leak management improvements can also be developed
without separating the leak into its intended and inadvertent
components.
[0141] Regardless of whether or not the overall leak can be
characterized as a function of time or pressure, the objective is
still to adjust the estimate of leakage so that its average value
is the same as the average value of the true leak over integral
respiratory cycles. Of course, the average of the true leak can be
obtained as the average of total flow since the patient flow
component of average total flow is zero.
[0142] If one assumes the leak is a function of pressure, such as
the leak from a WHISPER SWIVEL.TM. connector, we than can assume
the leak will likely be less at EPAP than it is at IPAP, with an
average value corresponding to a pressure between EPAP an IPAP.
That is, for a leak which is a function of pressure, the leakage
rate at a lower pressure is less than the leakage rate at a higher
pressure. This characteristic of leak flow can be utilized in
algorithms other than that described hereinabove to compensate for
system leakage.
[0143] In all systems described herein, the purpose of determining
leakage is to thereby determine patient flow in an open system. Of
course, a closed system ideally has no leaks, but in practice may
have inadvertent leaks; however, in an open system gas flow from
the system, whether by a regulated leak at an exhaust point or
through inadvertent leaks from tubing connections and seal
interfaces, will constitute a significant part of the total system
flow. Accordingly, leakage in the patient circuit of an open system
can be calculated by using the total flow as detected by a
pneumotach. This parameter, which we refer to as raw flow, includes
all flow leaving or entering the gas flow source (e.g., a blower)
via the patient circuit. Therefore, raw flow includes both patient
flow and system leakage. The purpose of the described leak
management algorithm is to separate raw flow into patient flow and
leakage components.
[0144] It is not necessary to directly measure either the patient
flow or leakage component of raw flow, but consequently the results
of the leakage calculations are to be regarded as estimated values.
One mode of leak management is discussed hereinabove with reference
to FIGS. 1 to 5. The following algorithm description relates to
alternative approaches to leak management.
[0145] For a non-pressure dependent leak, one first determines when
patient inhalation begins. We refer to this point in the patient's
respiratory cycle as the breath trigger and use it as a reference
point to compare patient inspiratory and expiratory volumes. By
using the beginning of inspiration as a breath trigger point, the
leakage calculation is done with the patient's beginning lung
volume at approximately the same level for every calculation.
[0146] The breath trigger reference point is identified by
satisfaction of two conditions as follows: (1) raw flow greater
than average leak rate; and (2) patient is ready to inhale.
Concerning the first of these conditions, the comparison of raw
flow with average leak rate reveals whether the patient is inhaling
or exhaling because, as noted above, the nature of the raw flow
component is such that raw flow exceeds system leakage during
patient inspiration and is less than system leakage during patient
expiration.
[0147] The second condition, that of determining whether the
patient is ready to inhale, is assessed by reference to either of
two additional conditions as follows: (1) the patient has exhaled a
predetermined fraction of the inhaled volume, for example 1/4 of
inhalation volume; or (2) the patient has exhaled for more than a
predetermined time, for example 300 milliseconds. An alternative
statement of the first of these conditions is that the patient's
exhaled volume is at least a significant fraction of inspiratory
volume. As to the second condition, and exhalation time of more
than 300 milliseconds can be detected by comparison of raw flow
with estimated average leakage rate since, as noted above, raw flow
is less than estimated average leak rate during exhalation. If raw
flow thus is less than the average leak rate for longer than 300
milliseconds, the condition is met. If either of the conditions 1
or 2 immediately above is met the patient is ready to inhale.
Therefore, if either of the conditions is met and in addition the
raw flow is greater than average leak rate, the conditions for a
breath trigger are satisfied and the described conditions thus can
be used to trigger the ventilator for an inspiratory cycle.
[0148] The seeming contradiction of requiring raw flow greater than
average leak rate to satisfy one breath trigger condition, and raw
flow less than average leak rate as one parameter that can satisfy
the second breath trigger condition is explained as follows. The
condition that raw flow is greater than average leak rate merely
indicates that the patient has begun an inhalation cycle; that is,
the patient has exerted the initial inspiratory effort that is
revealed as raw flow exceeding average system leakage. However, as
discussed hereinabove, since the raw flow signal can and does cross
the average leak rate signal due to spurious noise in the raw flow
signal, not all incidents of raw flow being greater than average
leakage will denote the beginning of patient inspiratory effort. In
fact, noise in the raw flow signal may typically result in multiple
crossing between the raw flow signal and the average leak signal.
Especially troublesome in this regard is noise causing a momentary
- to + transition while the actual major condition is the flow
crossing zero due to a true inspiratory to expiratory
transition.
[0149] In order to avoid multiple triggers at these points of
signal crossings that do not denote initial patient inspiratory
effort, the additional ready-to-inhale condition is imposed. Under
this condition, the raw flow greater than average leak condition is
validated only if one of the two conditions indicating the
patient's respiration was just previously in an exhalatory state is
satisfied. In the case of the second of these conditions, the 300
millisecond duration of raw flow less than average leakage
corresponds to patient exhalation. Thus, the time element plays a
role in the described breath trigger algorithm and must be
understood. Raw flow less than average leakage indicates exhalation
which then provides a ready-to-inhale output. A subsequent reversal
of raw flow to a value greater than average leakage indicates the
detection of a patient inspiratory effort. The breath trigger thus
consistently initiates an inspiratory cycle in synchronism with
spontaneous patient respiration.
[0150] When the breath trigger occurs, the ready-to-inhale
parameter is reset to await satisfaction of one of the two
conditions specified above that provides a ready-to-inhale
validation. The breath triggering process is then repeated upon
occurrence of the next patient inspiratory effort when raw flow
again exceeds average system leakage.
[0151] The time interval between breath triggers from one breath to
the next can be captured and the raw flow signal integrated over
that time interval to find the raw volume or total volume for each
breath. The raw volume may then be divided by the time between
breath triggers, for example the time interval between the next
successive pair of breath triggers, to determine a recent time rate
of leakage.
[0152] It is noted that the patient's respiration from one breath
trigger to the next, as represented by the integration of the raw
flow signal, rises from zero volume to a maximum value comprised of
inspiratory volume and leakage volume during inspiration. As the
respiratory cycle continues through expiration, the continued
integration of negative flow reduces the raw volume parameter
progressively as the exhaled volume is subtracted. Thus, at the
next breath trigger, the raw volume parameter from the prior breath
is equal to only the leakage volume and any change in patient
resting volume; however, this latter value generally is assumed to
be zero.
[0153] Thus, as the raw volume parameter is really only leak
volume, dividing that value by the time duration of the breath
provides an estimate of the leak rate for the most recent breath.
By averaging the recent leak rate over time in an average leak rate
can be determined to provide a more stable signal. Among other
benefits, this reduces an effects of breath-to-breath volume
variation resulting from breath-to-breath changes in patient
resting volume. The number of respiratory cycles over which the
recent leak may be averaged to determine average leak rate may be
anywhere between one and infinity, depending upon the desired
balance between signal stability and rapid error correction. Longer
term averaging results in greater stability but slower error
correction. Shorter term averaging provides less stability but
quicker error correction.
[0154] Finally, it is to be noted that the average leak rate whose
calculation is described here was used initially in this algorithm
in one of the conditions for imitating a breath trigger. The
parameters used in conditions for initiating a breath trigger thus
can be continually updated, used to satisfy the breath trigger
conditions, and then the successive breath triggers are used in
turn to again update these parameters.
[0155] A related approach to leakage analysis involves the use of a
leak component which is, or is assumed to be, a function of patient
circuit pressure. This sort of leak analysis can be useful in such
ventilation regimes as, for example, proportional assist
ventilation such as described in U.S. Pat. No. 5,107,830. It is
important in proportional assist ventilation to know both the
average leak rate and the instantaneous leak for the system.
However, proportional assist ventilation involves variation of
pressure according to the level of ventilation assistance required
by the patient from moment to moment. Since at least some
components of system leakage can be a function of pressure, those
components will also vary more or less in synchronism with varying
patient ventilation needs.
[0156] Thus, an alternative algorithm for leak analysis that can be
used in a proportional assist ventilation system and in other
systems as deemed suitable would be based on the requirement that
patient flow equals raw flow, as defined hereinabove, less any
known leak component and any pressure dependent leak component.
Known leakage may be any leak, intentional or otherwise, having
known flow characteristics, for example the leakage through a
WHISPER SWIVEL.TM. or though a plateau exhalation valve. That is,
the known leak is not necessarily a fixed leak, but can also be a
function of pressure. Although such leaks of known characteristics
could be lumped together with leaks having unknown characteristics
but assumed to be functions of pressure, the following analysis can
be carried out with leaks of known characteristics included or
excluded from the leakage calculation described.
[0157] The pressure dependent leak, whether constituted of total
leakage or only a component of total leakage, is calculated as a
function of system pressure from analysis or the raw flow signal.
One function by which the pressure dependent leak component is
related to pressure is that for any orifice defining a pressure
drop between a pressurized system and a lower pressure surrounding
environment, the flow through the orifice will be proportional to
the square root of the pressure difference across the orifice
multiplied by a constant K which characterizes the mechanical
features of the orifice itself, that is its size, surface
smoothness, and so forth.
[0158] To find the pressure dependent leak component, it is
necessary only to characterize one hypothetical orifice as
representing the source of all pressure dependent leakage. To find
the hypothetical orifice, the breath trigger defined above is
utilized to mark the beginning and end of patient respiratory
cycles, and the average patient circuit pressure is measured for
each breath. The average leak rate, as calculated hereinabove, is
multiplied by the time duration of the previous breath to determine
pressure dependent leak volume on a per-breath basis. If the
pressure dependent leak component is separated from the known leak
component, then the known leak component is also separated from
average leak rate before the average leak rate is used to determine
pressure dependent leak volume.
[0159] The pressure dependent leak volume is then divided by the
average of the square root of pressure for the prior breath to give
the corresponding orifice characteristic K. Over the next breath,
the pressure dependent leak is found by multiplying the calculated
orifice characteristic K by the square root of instantaneous
pressure. This gives the pressure dependent leak rate as a function
of pressure throughout the breath. This is an important parameter
in such ventilation regimens as the above characterized
proportional assist ventilation. More generally, however, it is
important for the therapist to have reliable information on system
leakage. The pressure dependent leak rate therefore can be useful
for characterizing leakage in a variety of ventilation systems.
[0160] For either of the last described leak calculations, recovery
routines are desired to deal with those instances when a breath
trigger does not occur when it should due to failure of the raw
flow signal to cross the average leak rate signal as the patient
breaths. When the system leak changes, the raw flow signal will
increase if the leak increases or decrease if the leak decreases.
It is possible for this increase or decrease to be large enough
that the raw flow signal never crosses the average leak rate, and
when this occurs there will be no breath trigger and thus no new or
updated leak calculations. To recover from such an incident, an
algorithm is needed to being the leakage calculations again and
thereby bring the calculated average leak rate back into line with
actual system functioning. Initiation of the recovery algorithm is
determined to be necessary if any one of four known physiological
events occurs as follows: (1) exhalation continues for more than 5
seconds; (2) inhalation continues for more than 5 seconds; (3)
inspiratory tidal volume is greater than 5 liters; or (4)
expiratory tidal volume is less than -1 liter.
[0161] The ventilator system should include elements for monitoring
operation to detect occurrence of any one of these events. When one
such event is detected, rediscovery of the leak is initiated by
changing the average leak rate to the raw flow signal by gradually
adding a percentage of the difference between raw flow and average
leak to the average leak rate. Preferably, the percentage of
difference added should be selected to provide a time constant of
approximately one second.
[0162] As the gradual increase in average leak rate in accordance
with the recovery algorithm causes the average leak rate value to
approach raw flow value, the increasing average leak rate
ultimately will cause a breath trigger in accordance with one of
the triggering algorithms as described above, and the repetitive
leak calculations will then resume with each respiratory cycle.
[0163] From the above leak management algorithm it may be seen that
the algorithm may also be based on comparison of estimated patient
flow to a zero value, and calculate only an unknown leak as a
function of pressure. In a manner similar to the leak management
algorithm above characterized, a breath indicator or trigger is
employed as a marker for the start of patient inspiration. The
breath trigger occurs when two conditions are met, namely: (1)
estimated patient flow is greater than 0; and (2) patient is ready
to inhale. The ready-to-inhale condition is satisfied when: (1) the
patient has exhaled a specified portion (e.g. 25%) of inspiratory
volume; (2) estimated patient flow is less than 0; and (3)
inspiratory volume is greater than a constant represented by 0 or a
small positive value.
[0164] As with the above-described algorithms, the conditions
requiring inspiratory volume to be both less than a percentage of
expiratory volume and greater than a small positive value are not
contradictory as these measurements are taken at different times.
First, the ready-to-inhale condition must be satisfied by the
specified parameters, including detection of an estimated patient
flow less than zero since the last inhalation. Then, a breath
trigger can occur when estimated patient flow goes positive since
estimated patient flow greater than 0 indicates initial patient
inhalatory effort.
[0165] From one breath trigger to the next, raw flow is integrated
and the square root of pressure is also integrated. Then at the
next breath trigger the unknown orifice is calculated by dividing
the value obtained from raw flow integration by the value obtained
from integration of the square root of pressure to provide the
characteristic K for the unknown orifice. As noted above, the
unknown orifice is a hypothetical leak source intended to describe
the characteristic of leakage from all sources of pressure
dependent leak.
[0166] Once the unknown orifice characteristic has been calculated,
it is multiplied by the square root of patient circuit pressure at
any time during the following breath to provide a measure of the
instantaneous unknown leak. Estimated patient flow is then found by
subtracting the instantaneous unknown leak from the raw flow.
[0167] In both of the algorithms which treat the system leak as the
gas flowing through a hypothetical orifice of characteristic K, the
constant K is calculated in essentially the same way. Although the
equation for the calculation is derived differently for the two
approaches, the result is the same, as follows: K = .intg. 0 T
.times. ( total .times. .times. flow ) .times. d t .intg. 0 T
.times. ( Pressure ) .times. d t . eq . .times. 1 ##EQU1##
[0168] We have noted above that as one aspect of the invention, we
calculate leakage as a function of gas pressure f(P(t)).
Accordingly, the equation for calculating the constant K can be
more generally stated as follows: K = .intg. 0 T .times. ( total
.times. .times. flow ) .times. d t .intg. 0 T .times. f .function.
( P .function. ( t ) ) .times. d t . eq . .times. 2 ##EQU2##
[0169] In cases where the system also includes a known leak
component such as a leak resulting from use of a plateau valve or a
WHISPER SWIVEL.TM. as described above, the calculations can be
modified to provide greater accuracy by subtracting the known leak
component from raw flow prior to integration of raw flow to
determine the unknown orifice, and also prior to utilizing raw flow
to determine estimated patient flow. In this case, the integral of
raw flow minus the known leak, divided by the integral of the
square root of patient circuit pressure will provide the parameter
K characterizing the unknown orifice attributable to only the
unknown leak. That orifice characteristic K can then be multiplied
by the square root of patient circuit pressure during the
subsequent breath to provide a measure of the unknown leak
component. Estimated patient flow at any time then would be found
by subtracting both the known leak and the calculated unknown leak
from the raw flow signal.
[0170] The modified algorithm preferably also includes a recovery
routine for essentially the same reasons as earlier stated. A
breath trigger for this modified algorithm depends upon estimated
patient flow crossing the zero value as the patient breaths. When
the leak value changes, both raw flow and estimated patient flow
will increase if the leak is increasing, or decrease if the leak is
decreasing. It is possible for such an increase or decrease to be
large enough that estimated patient flow will never cross the 0
value. When this occurs no breath trigger occurs and there will be
no new or updated leak calculations unless a recovery routine is
performed.
[0171] To correct this condition, a recovery algorithm may be
utilized to detect when leakage calculation is out of control
according to two limiting parameters as follows: (1) inspiratory
tidal volume is greater than a physiological value such as 4.5
liters; or (2) inspiratory tidal volume is less than a
non-physiological value such as -1 liter. When either of these
non-physiological events occurs, the leakage calculation is out of
control and the system leak must be rediscovered by artificially
inducing a breath trigger. Thus, the system would require flow
detecting apparatus to sense the specified limiting values of
inspiratory tidal volume and provide a breath trigger reference
point. This restarts system operation essentially in the same
manner as described above with reference to other algorithms, and
thus initiates a new leak calculation. The data used for these
continued calculations can include data from after the change in
leak magnitude so that the estimate of the unknown leak is
improved. Even if the new unknown leak value is incorrect,
continuing repeated calculations also will be based on data from
after the change in leak magnitude. Thus, the calculated estimate
of unknown leak will continue to quickly approach reliable
values.
[0172] FIG. 12 illustrates the described leak management algorithm
in action, with intentional introduction of a very large leak. In
FIG. 12, the four traces represent, from top to bottom, pressure,
estimated patient flow, estimated inspiratory volume, and estimated
leak (combined known and unknown leakage). The X axis is
progressing time moving from left to right.
[0173] As can be seen from FIG. 12, for the first three respiratory
cycles the algorithm is able to determine leakage as a function of
pressure. At the start of each inspiration an unknown orifice
characteristic K is calculated. Points 1 and 2 on the estimated
leak trace show the transitions between one unknown orifice
characteristic K and the next, which is an updated unknown orifice
characteristic. Point 2 on the estimated leak trace shows a much
smoother transition between old and new unknown orifice
characteristics than does point 1, thus indicating that point 2 is
a transition between unknown orifice characteristics of essentially
the same value.
[0174] To test algorithm response to leakage, a very large leak was
introduced as indicated at point 0 on the estimated patient flow
trace. Predictably, the estimated patient flow and estimated
inspiratory volume rise off scale very quickly. At time T,
estimated inspiratory volume has reached 4.5 liters and a breath
trigger thus is forced. The resulting calculation estimates the
leak to be a very high value which, in the estimated leak portion
of FIG. 12 is off scale. The resulting estimated patient flow is
approximately 50 liters per minute where in fact it should be zero.
Tidal volume continues to rise rapidly as indicated at point 3 and
would ultimately force another breath trigger when it reached the
4.5 liter limit. The large system leak is removed at time T',
however, so the rise in tidal volume ceases.
[0175] With the leak removed from the system, estimated patient
flow and estimated inspiratory volume rapidly drop off scale. Thus,
when inspiratory tidal volume reaches the recovery limit of -1
liter, another breath trigger is forced thus leading to a new leak
calculation and a resulting estimated leak lower than the previous
leak calculation. This brings estimated patient flow back onto
scale. Although the new leak calculation is better than the
previous one, it is not by any mean perfect. With estimated patient
flow based on the new unknown leak orifice characteristic, tidal
volume may once again drop below the -1 liter limit such as
indicated at point 4 thus forcing another breath trigger. Once
again a new unknown orifice calculation is performed and used for
an unknown leak calculation which results in a very good value,
thus returning the system to normal ranges of operation. The system
thus was reliable in recovery from even very large changes in leak
magnitude. The much smaller changes in leak magnitude that are more
commonly encountered are readily handled under this algorithm by
either the normal calculation or the recovery calculation.
[0176] Of course, we have contemplated various alternative and
modified embodiments of the invention of which the above described
are exemplary as the presently contemplated best modes for carrying
out the invention. Such alternative embodiments would also surely
occur to others skilled in the art, once apprised of our invention.
Accordingly, it is intended that the invention be construed broadly
and limited only by the scope of the claims appended hereto.
* * * * *