U.S. patent application number 13/363785 was filed with the patent office on 2012-05-24 for adjustment of ventilator pressure-time profile to balance comfort and effectiveness.
This patent application is currently assigned to ResMed Limited. Invention is credited to Peter Bateman, Michael Berthon-Jones, Gordon Malouf.
Application Number | 20120125336 13/363785 |
Document ID | / |
Family ID | 24062560 |
Filed Date | 2012-05-24 |
United States Patent
Application |
20120125336 |
Kind Code |
A1 |
Berthon-Jones; Michael ; et
al. |
May 24, 2012 |
ADJUSTMENT OF VENTILATOR PRESSURE-TIME PROFILE TO BALANCE COMFORT
AND EFFECTIVENESS
Abstract
The invention is a ventilator whose servo-controller adjusts the
degree of support by adjusting the profile of the pressure waveform
as well as the pressure modulation amplitude. As the
servo-controller increases the degree of support by increasing the
pressure modulation amplitude, it also generates a progressively
more square, and therefore efficient, pressure waveform; when the
servo-controller decreases the degree of support by decreasing the
pressure modulation amplitude, it also generates a progressively
more smooth and therefore comfortable pressure waveform.
Inventors: |
Berthon-Jones; Michael;
(Leonay, AU) ; Bateman; Peter; (Castle Hill,
AU) ; Malouf; Gordon; (Elizabeth Bay, AU) |
Assignee: |
ResMed Limited
Bella Vista
AU
|
Family ID: |
24062560 |
Appl. No.: |
13/363785 |
Filed: |
February 1, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12100051 |
Apr 9, 2008 |
8122885 |
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13363785 |
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10841302 |
May 7, 2004 |
7367337 |
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12100051 |
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10424344 |
Apr 28, 2003 |
6755193 |
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10841302 |
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09518101 |
Mar 3, 2000 |
6553992 |
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10424344 |
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Current U.S.
Class: |
128/204.23 ;
128/204.21 |
Current CPC
Class: |
A61M 16/0069 20140204;
A61M 2016/0036 20130101; A61M 16/0858 20140204; A61M 2205/15
20130101; A61M 2205/3344 20130101; A61M 16/024 20170801 |
Class at
Publication: |
128/204.23 ;
128/204.21 |
International
Class: |
A61M 16/00 20060101
A61M016/00 |
Claims
1. A pressure support ventilator comprising: a flow generator to
generate a flow of gas at a pressure, the pressure being a function
of at least a waveform, an amplitude, and a smoothness parameter;
and a processor configured to determine a measure of ventilation of
the patient, and to automatically adjust the smoothness parameter
within a preset range to servo-control the measure of ventilation
to at least equal a target ventilation.
2. The pressure support ventilator of claim 1, wherein the waveform
is a function of time.
3. The pressure support ventilator of claim 1, wherein the waveform
is a function of phase in a respiratory cycle.
4. The pressure support ventilator of claim 1, wherein the waveform
is a function of time and phase in a respiratory cycle.
5. The pressure support ventilator of claim 1, wherein the waveform
approximates a waveform shape of eupneic transdiaphragmatic
pressure versus phase curve.
6. The pressure support ventilator of claim 1, wherein the pressure
is a function of at least a first smoothness parameter and a second
smoothness parameter.
7. The pressure support ventilator of claim 6, wherein the first
smoothness parameter is configured to servo-control the measure of
ventilation during inspiration, and the second smoothness parameter
is configured to servo-control the measure of ventilation during
expiration.
8. The pressure support ventilator of claim 1, wherein the first
smoothness parameter is configured to servo-control the measure of
ventilation during early inspiration and expiration, and the second
smoothness parameter is configured to servo-control the measure of
ventilation during late inspiration and expiration.
9. The pressure support ventilator of claim 1, wherein the
smoothness parameter is adjusted to generate a pressure waveform
that progressively varies between a square profile and a smooth
profile.
10. The pressure support ventilator of claim 9, wherein when the
smoothness parameter increases, the pressure waveform progressively
becomes a more smooth and less square pressure waveform, and
wherein when the smoothness parameter decreases, the pressure
waveform progressively becomes a less smooth and more square
pressure waveform.
11. The pressure support ventilator of claim 9, wherein the
pressure waveform includes a first, non-decreasing portion during
inspiration and a second, non-increasing portion during
expiration.
12. The pressure support ventilator of claim 11, wherein when the
smoothness parameter changes, the first, non-decreasing portion
progressively varies between a raised cosine waveform and a rising
step waveform, and the second, non-increasing portion progressively
varies between a quasi-exponential decay waveform and a descending
step waveform.
13. The pressure support ventilator of claim 1, wherein the
processor is further configured to automatically adjust the
amplitude within a preset range to servo-control the measure of
ventilation to at least equal the target ventilation.
14. The pressure support ventilator of claim 1, wherein the
smoothness parameter is controlled to be a function of the
amplitude.
15. The pressure support ventilator of claim 1, wherein the
servo-control is performed firstly by increasing or decreasing the
amplitude, and secondarily adjusting the smoothness parameter if
the measure of ventilation remains below the target
ventilation.
16. The pressure support ventilator of claim 1, wherein when the
measure of ventilation is inadequate, a degree of ventilatory
support is increased by at least one of increasing the amplitude
and decreasing the smoothness parameter, and when the measure of
ventilation exceeds that required by the patient, the degree of
ventilatory support is decreased by at least one of decreasing the
amplitude and increasing the smoothness parameter.
17. A pressure support ventilator comprising: means for delivering
a controlled supply of breathable gas to a patient's airway at a
pressure, the pressure being a function of at least a waveform, an
amplitude and a smoothness parameter; means for determining a
measure of ventilation of the patient; and means for automatically
adjusting the smoothness parameter within a preset range to
servo-control the measure of ventilation to at least equal a target
ventilation.
18. The pressure support ventilator of claim 17, wherein the
waveform is a function of time.
19. The pressure support ventilator of claim 17, wherein the
waveform is a function of phase in a respiratory cycle.
20. The pressure support ventilator of claim 17, wherein the means
for automatically adjusting controls the smoothness parameter to
generate a pressure waveform that progressively varies between a
square profile and a smooth profile.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 12/100,051, filed Apr. 9, 2008, which is a
continuation of U.S. patent application Ser. No. 10/841,302, filed
on May 7, 2004, now U.S. Pat. No. 7,367,337, which application is a
continuation of U.S. patent application Ser. No. 10/424,344, filed
on Apr. 28, 2003, now U.S. Pat. No. 6,755,193, which is a
continuation of U.S. patent application Ser. No. 09/518,101, filed
on Mar. 3, 2000, now U.S. Pat. No. 6,553,992, the disclosures of
which are hereby incorporated herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates to the field of mechanical
ventilation, and more particularly to machines and methods for
providing a patient with ventilatory support.
BACKGROUND OF THE INVENTION
[0003] Conventional ventilators provide ventilatory support by
utilizing a number of different pressure-time profiles. In its
simplest form, a ventilator delivers airflow at a fixed rate (or
some other fixed function of time such as sinusoidally), and the
airway pressure increases passively as a function of the mechanical
properties of the patient's respiratory system. Such a ventilator
is in general suitable only for a paralyzed and sedated patient who
cannot change his/her ventilation at will. Also, the system is
intolerant of leak, so is unsuitable for non-invasive (mask)
ventilation.
[0004] A bi-level ventilator uses a square pressure-time
waveform:
P=P.sub.0+A, f>0
P=P.sub.1 otherwise
where Po is an end expiratory pressure, chosen to splint the upper
and lower airways and alveoli, A is a fixed pressure modulation
amplitude chosen to supply a desired degree of support, and f is
respiratory airflow. Here, and throughout what follows, inspiratory
flow is defined to be positive, and expiratory flow is defined to
be negative. With bi-level support, the patient can breathe as much
or as little as he wishes, by using greater or lesser effort, and
the system is somewhat less affected by leak. Some known
ventilators, for example, the Servo 300 available from Siemens
Medical, Iselin, N.J., and the VPAP-ST from ResMed, San Diego
Calif., have an adjustment for changing the initial rate of rise of
pressure, with the intention of providing a more comfortable
waveform by using a slower rate of rise. In such prior art, the
clinician selects a particular waveform, but thereafter the
waveform does not change, and there is no automatic adjustment of
the waveform.
[0005] Moving on in complexity, a proportional assist ventilator
provides pressure equal to an end expiratory pressure Po plus a
resistance R multiplied by respiratory airflow, plus an elastance E
multiplied by the time integral of respiratory airflow:
P=P.sub.0+Rf+E.intg.f dt, f>0
P=P.sub.0+Rf, otherwise
(where the integral is from the time of start of the current
inspiration to the current moment} in which the resistance R is
chosen to unload some or all of the resistive work of breathing,
and the elastance E is chosen to unload some or all of the elastic
work of breathing (that is to say, the Rf term provides a pressure
increment to offset some or all of the effort required to get air
to flow through the mechanical passageways, and the integral term
provides some or all of the pressure required to overcome the
elastic recoil or springiness of the lungs and chest wall). A
proportional assist ventilator amplifies patient effort, delivering
a natural-feeling waveform, and it is easier for the patient to
increase or decrease his ventilation than in the case of bi-level
support. However, a proportional assist ventilator is
disadvantageous for a patient with abnormal chemoreflexes, as
inadequate support is provided during pathological reductions in
effort such as central apneas and hypopneas.
[0006] Another approach is to provide a pressure-time profile that
is continuous function of phase in the respiratory cycle:
P=P.sub.0+A .PI.(.PHI.),
Where .PI.(.PHI.) is a waveform template function, for example, as
shown in FIGS. 1, and .PHI. is the phase in the respiratory cycle.
In FIG. 1, the waveform template is a raised cosine during the
inspiratory part of the cycle, followed by a quasi-exponential
decay during the expiratory portion. This shape will produce a
quasi-normal and therefore comfortable flow-time curve if applied
to a passive patient with normal lungs.
[0007] For example, a servo-ventilator can be constructed by
setting the pressure modulation amplitude A to:
A=-G.intg.(0.5|f|-V.sub.TGT)dt,
where G is a servo gain (for example, 0.3 cmH.sub.20 per L/min per
second), V.sub.TGT is a desired target ventilation (e.g., 7.5
L/min), and the integral is clipped to lie between A.sub.MIN and
A.sub.MAX (for example, 3 and 20 cmH.sub.20) chosen for comfort and
safety. A servo-ventilator has the advantage of guaranteeing a
specified ventilation. By setting A.sub.MIN to be non-negative, the
patient can at will comfortably breathe more than the target
ventilation, but in the event of a failure of central respiratory
drive, the device will guarantee at least a ventilation of
V.sub.TGT.
[0008] Finally, the advantages of using a waveform template can be
combined with resistive unloading:
P=P.sub.0+Rf+A .PI.(.PHI.),
where
A=-G.intg.(0.5|f|-V.sub.TGT)dt,
0<=A.sub.MIN<=A<=A.sub.MAX.
as before, giving yet more comfort to an awake patient than in the
case previously considered, yet without losing a guaranteed minimum
ventilation of V.sub.TGT.
[0009] A disadvantage of the pressure waveform template shown in
FIG. 1 is that it is less efficient than a square wave. That is to
say, for any given amplitude it provides less ventilatory support
than a square wave. The waveform of FIG. 1 has only half the area
of a square wave of the same amplitude. This can be a problem in
patients who require a very high degree of support, or in the case
of mouth leak, where in order to provide a desired pressure
modulation amplitude at the glottic inlet, a much higher pressure
modulation amplitude must be supplied at the mask. The use of pure
resistive unloading is similarly inefficient for the same reason:
the area under the pressure-vs-time curve is only half that of a
square wave of the same amplitude. Even the combination of the
smooth waveform template with resistive unloading is less efficient
than a square wave of the same amplitude.
[0010] It is a general object of our invention to provide a
pressure support ventilator that offers the advantages of using a
smooth pressure waveform template while at the same time
compensating for its disadvantages.
[0011] It is another object of our invention to balance comfort and
effectiveness in a ventilator.
SUMMARY OF THE INVENTION
[0012] One broad concept implemented by the invention is to change
the pressure waveform in a way that makes an advantageous trade-off
between comfort and efficiency, using a more efficient but less
comfortable waveform only when needed.
[0013] One aspect of the invention is a ventilator whose
servo-controller adjusts the degree of support by adjusting the
profile of the pressure waveform, preferably while also adjusting
the pressure modulation amplitude.
[0014] In particular, the servo-controller increases the degree of
support by increasing the pressure modulation amplitude, and also
by generating a progressively more square, and therefore efficient,
pressure waveform; the servo-controller decreases the degree of
support by decreasing the pressure modulation amplitude, and by
generating a progressively more smooth and therefore comfortable
pressure waveform. The changes in amplitude and squareness can be
performed sequentially, or partially or completely
simultaneously.
BRIEF DESCRIPTION OF THE FIGURES
[0015] Further objects, features and advantages of the invention
will become apparent upon consideration of the following detailed
description in conjunction with the drawing, in which:
[0016] FIG. 1 depicts a smooth and comfortable ventilator waveform
template function;
[0017] FIG. 2 depicts illustrative apparatus for implementing the
method of the invention; and
[0018] FIGS. 3 and 4 show two alternative variable templates for
use in the apparatus of FIG. 2 in accordance with the invention,
the shape of each template being a function of the instantaneous
difficulty in ventilating the patient.
DETAILED DESCRIPTION OF THE INVENTION
[0019] Suitable apparatus for implementing the invention is shown
in FIG. 2. The apparatus provides breathable gas at controllable
positive pressure to a patient's airway. In the drawing, a blower
10 supplies breathable gas to a mask 11 in communication with a
patient's airway via a delivery tube 12 and exhausted via an
exhaust 13. Airflow at the mask 11 is measured using a
pneumotachograph 14 and a differential pressure transducer 15. The
mask flow signal f(t) from the transducer is then sampled by a
microprocessor 16. Mask pressure is measured at the port 17 using a
pressure transducer 18. The pressure signal from the transducer 18
is then sampled by the microprocessor 16. The microprocessor sends
an instantaneous mask pressure request (i.e., desired mask
pressure) signal P(t) to a servo-controller 19, which compares the
pressure request signal with the actual pressure signal from the
transducer 18 to control a fan motor 20. Microprocessor settings
can be adjusted via a serial port, not shown.
[0020] It is to be understood that the mask could equally be
replaced with a tracheotomy tube, endotracheal tube, nasal pillows,
or other means of making a sealed connection between the air
delivery means and the patient's airway.
[0021] The microprocessor accepts the mask airflow and pressure
signals, and from these signals determines the instantaneous flow
through any leak between the mask and patient, by any convenient
method. For example, the conductance of the leak may be estimated
as the instantaneous mask airflow, low-pass filtered with a time
constant of 10 seconds, divided by the similarly low-pass filtered
square root of the instantaneous mask pressure, and the
instantaneous leakage flow may then be calculated as the
conductance multiplied by the square root of the instantaneous mask
pressure. Respiratory airflow is then calculated as the
instantaneous mask airflow minus the instantaneous leakage
flow.
[0022] Throughout the following discussion, the phase in the
respiratory cycle .PHI. is taken as varying between zero and 1
revolution, with zero corresponding to start of inspiration and 0.5
corresponding to start of expiration.
[0023] The desired mask pressure is described by the following
equations:
P=P.sub.0+Rf+A .PI.(.PHI.),
where:
[0024] P.sub.0 is a desired end expiratory pressure chosen to
splint the upper and lower airways or alveoli, or to reduce cardiac
preload or afterload, for example, 5 cmH.sub.20;
[0025] R may be zero, but is preferably any value less than the
patient's actual airway resistance;
[0026] f is respiratory airflow, measured, for example, using a
pneumotachograph in the mask, and correcting for leak, for example,
as described in the commonly owned International Publication
referred to above;
[0027] .PHI. is the phase in the patient's respiratory cycle;
[0028] .PI..PHI. is a pressure waveform template, initially set to
be similar to that shown in FIG. 1, for example, comprising a
raised cosine followed by an exponential decay.
[0029] In a very simple form, suitable for a patient who is making
no spontaneous efforts, or in whom the spontaneous efforts can be
ignored, the phase .PHI. simply increases linearly with time,
modulo 1 revolution. In a .preferred form, the phase .PHI. is
calculated, for example, from the respiratory airflow f using fuzzy
logic as taught in the commonly owned International Publication No.
WO 98/12965 entitled "Assisted Ventilation to Match Patient
Respiratory Need," referred to above.
[0030] An example of a smooth and comfortable pressure waveform
template .PI..PHI. is shown in FIG. 1. This particular waveform
consists of a raised cosine followed by a quasi-exponential decay.
(Unlike a true exponential decay, the waveform of FIG. 1 falls
exactly to zero by the end of expiration, so that there is no step
change at the start of the next breath.)
[0031] The first reason why the waveform of FIG. 1 is more
comfortable than a traditional square wave is that the more sudden
changes in pressure associated with a square wave are more
intrusive than the smoother changes in pressure of FIG. 1.
[0032] The second reason why the waveform of FIG. 1 is more
comfortable, whereas a traditional square wave is less comfortable,
relates to precise synchronization of the delivered pressure to the
patient's own muscular efforts. The more precise the
synchronization, the more comfortable the waveform. The term Rf in
the equation
P=P.sub.0+Rf+A .PI.(.PHI.)
given above can be adjusted to obviate some or most of the effort
required to unload resistive work. By a suitable choice of the
amplitude A, and a suitable waveform .PI.(.PHI.), the term A
.PI.(.PHI.) can be adjusted to unload most of the normal or
pathological elastic work at the eupneic tidal volume, or
alternatively at a minimum desired tidal volume, leaving the
patient free to breathe deeper if he wishes. The reason for this is
that a eupneically breathing subject's inspiratory flow-time curve
is quasi-sinusoidal, and therefore the elastic component of effort,
which is proportional to the integral of flow, is a raised cosine.
For this reason, the waveform of FIG. 1 has a raised cosine during
inspiration. During early expiration, a normal subject's muscular
effort does not drop instantaneously to zero, but remains active
some time into expiration, decaying gradually, which maintains a
high lung volume longer than would otherwise be the case, thereby
helping keep the alveoli inflated, and also providing a smoother
movement of the chest wall. For this reason, the waveform of FIG. 1
has a quasi: exponential decay during expiration. An additional
advantage of the waveform of FIG. 1 over a square wave is that
small errors in timing of the start of inspiration produce
negligible errors in the delivered pressure, whereas with a square
wave, a timing error causes the delivered pressure to be wrong by
the entire amplitude of the waveform. Therefore, the waveform of
FIG. 1 will feel better synchronized to the subject's efforts than
a square wave.
[0033] Primary interest is in waveform templates which are
non-decreasing during the inspiratory half of the cycle,
non-increasing during the expiratory half, and with the first
derivative defined everywhere except at the transitions between
inspiration and expiration and vice versa. Of particular importance
are waveform templates which are families of functions indexed by a
single smoothness parameter K, which can for concreteness take
values between zero (least smooth, or most square) and 1 (most
smooth). The maximum absolute value of the derivative (of the
waveform template with respect to phase) increases as smoothness K
decreases. Thus in the family of waveform templates shown in FIGS.
3 and 4, each waveform is smoother than the waveform immediately to
the left.
[0034] As the patient's ventilatory requirements increase, the
smooth and comfortable waveform template changes to a progressively
more square (and therefore more efficient, but generally less
comfortable) waveform. In a preferred form, the pressure waveform
template is a function of a smoothness variable K. When K=1.0, the
template is smooth as shown in FIG. 1. When K=0.0, the template is
a square wave, and intermediate values of K generate intermediate
waveforms.
[0035] FIG. 3 shows one way in which the waveform can vary with K
to generate intermediate waveforms. During inspiration, .PI.(.PHI.)
is a blend between a raised cosine and a rising exponential, the
time constant of the exponential decreasing with K. During
expiration, .PI.(.PHI.) is a decaying exponential, also with a time
constant that decreases as K increases. Letting, for K>0
u=0.5[1-cos(2.pi..PHI.)]
v=a(1-e.sup.-5.PHI./K)
where
a=1/(1-e.sup.-2.5/K)
we define
.PI.(.PHI.)=K u+(1-K)v, .PHI.<0.5
.PI.(.PHI.)=1-a(1-e.sup.-5(.PHI.-0.5)/K), otherwise
[0036] The equations degenerate to a square wave when K=O. The
purpose of the constant a is to ensure that .PI.(.PHI.) approaches
zero as .PHI. approaches 0.5 and also as .PHI. approaches
unity.
[0037] As K decreases, two things happen to the inspiratory part of
the curve: the exponential becomes progressively more like a rising
step function, and the exponential contributes progressively more
to the template, generating a family of curves intermediate between
a raised cosine and a square wave. Similarly, ask decreases, the
exponential in the expiratory part of the curve becomes more like a
descending step function.
[0038] FIG. 4 shows another method, in which the inspiratory part
of the curve is a raised cosine followed by a straight line:
.PI.(.PHI.)=0.5[1-cos(2.pi..PHI./K)], .PHI.<0.5, .PHI.<0.5
K
.PI.(.PHI.)=1-a(1-e-5(.PHI.-0.5)/K), .PHI.>0.5
.PI.(.PHI.)=1, otherwise
where
a=1/(1-e.sup.-2.5/K)
[0039] In this method, with K=1.0, the straight line segment
vanishes and the inspiratory curve is a raised cosine. As K
decreases, the straight line segment lengthens and the raised
cosine is squashed progressively to the left. Again, the equations
degenerate to a square wave with K=0.0.
[0040] In both embodiments, the object is to use K=1.0 when small
degrees of support are required, K=0.0 when very large degrees of
support are required, and intermediate values of K in between.
[0041] In a simple form of the invention, K is adjusted in order to
servo-control the patient's minute ventilation to equal a chosen
target. For example, K may be adjusted using clipped integral
control as follows:
K=G.intg.(0.5|f|-V.sub.TGT)dt, 0<=K<=1
where:
[0042] G is a gain, for example, 0.01 per L/min per second;
[0043] VTGT is the chosen target ventilation, for example, 7.5
L/min;
[0044] The reason for dividing the absolute value of the
respiratory airflow by two is as follows. The target ventilation
V.sub.TGT is specified with the units of L/min. Normally,
ventilation is calculated as either the entire volume inspired per
minute (inspired minute ventilation), or the entire volume expired
per minute (expired minute ventilation). Equally, it can be
calculated as the average of these two, in which case the average
minute ventilation is half the average of the absolute value of the
respiratory airflow over any given minute. More generally, the
average ventilation is the average of half the absolute value of
the respiratory airflow over any chosen period of time. Omitting
the averaging step, we see that the instantaneous ventilation is
half the absolute value of the respiratory airflow, and the term
0.5|f|-V.sub.TGT is the error in the instantaneous ventilation, and
is therefore (on average) a measure of the adequacy of ventilation.
If the term 0.5|f|-V.sub.TGT is on average positive, then the
subject requires less ventilatory support, and conversely if it is
on average negative, then the subject requires more ventilatory
support. The clipped integral controller servo-controls this
quantity to be zero on average, and therefore servo-controls the
instantaneous ventilation to on average equal the target
ventilation, whereupon the average ventilation also equals the
target ventilation.
[0045] In this embodiment, if the subject is exceeding the target
ventilation, the value of K will increase, yielding progressively
smoother, more comfortable, but less efficient waveforms, until
either the actual ventilation decreases to equal the target
ventilation, or until K reaches 1.0, which yields the smoothest
waveform. Conversely, if the subject is not achieving the target
ventilation, K will decrease gradually, causing the waveform to
become more square and more efficient, until either the target
ventilation is achieved, or until K=0.0, representing a perfectly
square waveform. For example, if K=1.0, V.sub.TGT=7.5 L/min, G=0.01
per L/min per second, and the subject ceases all respiratory
airflow, K will decrease to zero in 13.3 seconds.
[0046] There are two ways of increasing the degree of ventilatory
support: using a more square waveform, and increasing the pressure
modulation amplitude A. Therefore, in the present invention, both
the smoothness K and the pressure modulation amplitude A may be
adjusted, either simultaneously or sequentially, in order to
achieve synergistically a desired target ventilation.
[0047] In a preferred form, a smooth waveform is used
preferentially, and as far as possible the desired target
ventilation is achieved by modulating the amplitude A, but if this
is unsuccessful, then a progressively more square waveform is used,
by decreasing K. In accordance with this form of the invention, the
pressure modulation amplitude A may be adjusted using a clipped
integral controller in order to servo-control minute ventilation to
equal a desired target ventilation as follows:
A=-G.intg.(0.5|f|-V.sub.TGT)dt,
0<=A.sub.MIN<=A<=A.sub.MAX
where:
[0048] G is a gain, for example, -0.3 cmH.sub.20 per L/min per
second;
[0049] V.sub.TGT is a chosen guaranteed minimum (target)
ventilation, for example, 7.5 L/min;
[0050] A.sub.MIN is a minimum pressure modulation amplitude, chosen
to make the patient comfortable while awake, for example, 3
cmH.sub.20; and
[0051] A.sub.MAX is a maximum pressure modulation amplitude, chosen
to be sufficient to do all respiratory work, within the constraints
of tolerability and safety, for example, 20 cmH.sub.20.
[0052] In the case where the patient's ventilation exceeds the
target V.sub.TGT, the pressure modulation amplitude A will reduce,
until either the ventilation on average equals V.sub.TGT and A lies
in the range A.sub.MIN<A<A.sub.MAX. or until A reaches
A.sub.MIN. Conversely, in the case where A.sub.MAX is insufficient
to ventilate the patient at V.sub.TGT. A will become equal to
A.sub.MAX.
[0053] In this preferred form, K is then calculated as a decreasing
function of the pressure modulation amplitude A. In other words, as
the pressure modulation amplitude A increases with the need for
greater ventilatory support, K decreases to provide still further
support (at the expense of comfort). Therefore, the pressure
waveform template .PI.(.PHI.) becomes a function of the pressure
modulation amplitude A. The invention delivers a comfortable,
smooth pressure-vs-phase (and therefore pressure-vs-time) curve,
providing the target ventilation V.sub.TGT is being achieved with a
pressure modulation amplitude less than a chosen maximum A.sub.MAX
but using a progressively more efficient, and therefore more
square, waveform in the case where the target ventilation cannot be
achieved using the chosen maximum.
[0054] To this end, the smoothness K may be calculated using
clipped integral control using the following pseudocode:
TABLE-US-00001 K = 1.0 REPEAT every 20 milliseconds Calculate A IF
A< A.sub.MAX Increment K by 0.002 ELSE Decrement K by 0.002 END
Truncate K to lie between 0.0 and 1.0 END
[0055] Initially, K=1.0, and the smoothest waveform will be used.
In the case where the patient is being well ventilated at or above
the target ventilation V.sub.TGTK will remain at 1.0 and the
patient will continue to receive a very smooth and comfortable
pressure waveform.
[0056] If the patient becomes difficult to ventilate, for example,
due to sputum retention, failure of respiratory drive, diaphragm
fatigue, failure of accessory muscles of respiration, mouth leak,
or a large leak which is exceeding the capacity of the blower, K
will gradually decrease towards zero.
[0057] The effect is that the actual delivered pressure waveform
.PI.(.PHI.) changes gradually and continuously between the
comfortable and smooth shape in FIG. 1, and a less comfortable but
more efficient square wave. In the most severe case with
ventilation remaining below V.sub.TGT and A remaining below
A.sub.MAX. K will reach zero in about 10 seconds, and a square wave
will be delivered. In a less severe case, as K decreases and the
waveform becomes progressively more square, and therefore more
efficient at generating ventilation, V.sub.TGT will be achieved at
an intermediate value of K and therefore at an intermediate
waveform shape.
[0058] Should the conditions which led to the requirement for a
more efficient waveform subside, the target ventilation V.sub.TGT
will be met, pressure modulation amplitude will reduce to below
A.sub.MAX, and K will again increase, yielding a smoother and more
comfortable waveform.
[0059] In the example given above, K increases at a maximum rate of
0.1 per second. Larger rates of change will produce a more rapid
increase in effectiveness of ventilatory support, but are likely to
lead to overshoot, with oscillations in the degree of support.
Smaller rates of change will be stable, but will take longer to
re-establish ventilation at V.sub.TGT.
[0060] In the above algorithm, the ventilator attempts to cope with
a need for increased ventilatory support in two discrete stages,
first by increasing the pressure modulation amplitude, while
maintaining the smooth waveform, but only up to a preset maximum
amplitude A.sub.MAX, and then subsequently by using a progressively
more efficient waveform. In other embodiments it is possible for
the two stages to overlap. For example, the pseudocode could be
changed to:
TABLE-US-00002 K= 1.0 REPEAT every 20 milliseconds Calculate A
Decrement K by 0.002(A - 0.75 A.sub.MAX) Truncate K to lie between
0.0 and 1.0 END
[0061] This algorithm performs identically to the previous
algorithm for the extreme cases of a patient who is either very
difficult or very easy to ventilate, but differs for intermediate
cases, because the transition from smooth to square begins earlier,
at 75% of A.sub.MAX. If more than 75% of the maximum pressure
modulation is being used, K will decrease, and the waveform will
become more square. Conversely, if more than 75% of the maximum
pressure modulation is being used, K will increase and the waveform
will become more rounded. Thus when increasingly ventilating the
patient, it is possible to adjust the trade-off between increasing
the pressure modulation amplitude and using a more efficient
waveform. In some cases, it may be desirable to prevent K from
reaching zero. For example, keeping 0.1<K<1.0 can produce
almost as great an increase in efficiency at low K, but is more
comfortable to the patient than a completely square waveform. This
is particularly the case if large amounts of resistive unloading
are used. {This is because a near-square waveform template on its
own will produce a rapid increase in flow at start of inspiration,
which will then produce yet further increase in pressure due to
resistive unloading.)
[0062] Alternatively, K can be made to increase quickly at first,
and then more slowly, so that the most square waveform is used only
as a last resort, for example, by submitting K to a square root or
similar transform. In other cases, with patients with considerable
air hunger and intrinsic PEEP, it may be desirable to limit K to a
value less than 1.0, although in general it would be preferable to
increase the resistive unloading Rand the end expiratory pressure
P.sub.0. In the above embodiments, K is related to the integral of
A {minus a threshold) with respect to time, essentially using an
integral controller to determine K, in an attempt to servo-control
ventilation to equal or exceed V.sub.TGT. In other embodiments,
other known controllers such as PID controllers may be used.
[0063] Although the invention has been described with reference to
particular embodiments, it is to be understood that these
embodiments are merely illustrative of the application of the
principles of the invention. In the above preferred embodiments,
the pressure waveform is a function of phase in the respiratory
cycle .PHI., calculated as is taught in the commonly owned
International Publication No. WO 98/12965 entitled "Assisted
Ventilation to Match Patient Respiratory Need". However, if it is
not desired to synchronize with the patient's spontaneous efforts,
phase can be taken as increasing linearly with time at a preset
rate, modulo 1 revolution. In this manner, the pressure waveform is
a simple function of time, and the invention simplifies to
modifying the shape of a fixed pressure-vs-time waveform. Thus, the
pressure waveform may be a function of the phase in the patient's
respiratory cycle, or time, or of both. Similarly, in the above
preferred embodiments, linear resistive unloading is used, but the
invention is applicable in the case of no resistive unloading, and
also in the case of nonlinear resistive unloading. In the preferred
embodiments described above, the pressure waveform template
comprises a raised cosine followed by a quasi-exponential decay.
However, the precise waveform is not overly critical. Waveforms
with the broad general features of FIG. 1 are satisfactory, and
will generally produce large improvements in comfort and
synchronization over a square wave. The waveform may be modified to
more or less precisely include eupneic resistive unloading by
setting the waveform to be more or less closely the shape of the
subject's eupneic transdiaphragmatic pressure-vs-phase curve.
Again, in the preferred embodiments, a fixed non-zero end
expiratory pressure is used, yet the invention extrapolates
naturally to either zero end expiratory pressure or to
automatically adjusted end expiratory pressure. Similarly, some
specific examples of how to adjust the shape of the pressure
waveform are given, but these are intended only as examples. In the
examples given, both the inspiratory and expiratory phases of the
pressure waveform template increase or decrease their smoothness.
In the illustrative embodiments, a single parameter K defines the
shape of the pressure waveform template. Also contemplated are
embodiments in which more than one parameter defines the template.
One example is to use one parameter for inspiration and another for
expiration, and vary them independently. Another is to use one
parameter which chiefly affects early inspiration and expiration,
and another which chiefly affects late inspiration and expiration.
Although the specific implementation delivers air from a blower,
the invention works equally well with air, oxygen, or other
breathable gases, and any source of breathable gas at controllable
pressure may be used. Numerous other modifications may be made in
the illustrative embodiments of the invention and other
arrangements may be devised without departing from the spirit and
scope of the invention.
* * * * *