U.S. patent application number 12/995458 was filed with the patent office on 2012-02-16 for control of humidifier chamber temperature for accurate humidity control.
This patent application is currently assigned to FISHER & PAYKEL HEATHCARE LIMITED. Invention is credited to Christopher Malcolm Crone, Jae Chul Han, Peter Hawkins, Kevin Peter O'Donnell, Andrew Robert Donald Somervell, Stanislav Tatkov.
Application Number | 20120037156 12/995458 |
Document ID | / |
Family ID | 41377298 |
Filed Date | 2012-02-16 |
United States Patent
Application |
20120037156 |
Kind Code |
A9 |
Tatkov; Stanislav ; et
al. |
February 16, 2012 |
CONTROL OF HUMIDIFIER CHAMBER TEMPERATURE FOR ACCURATE HUMIDITY
CONTROL
Abstract
A breathing assistance system for delivering a stream of heated,
humidified gases to a user, comprising a humidifier unit which
holds and heats a volume of water, and which in use receives a flow
of gases from a gases source via an inlet port, the flow of gases
passing through the humidifier and exiting via an exit port, the
system further having a temperature sensor which measures the
temperature of the gases exiting the humidifier unit, an ambient
temperature sensor which measures the temperature of gases before
they enter the humidifier unit, and a flow sensor which measures
the flow rate of the gases stream, the system also having a
controller which receives data from the temperature and flow
sensors, and which determines a control output in response, the
control output adjusting the power to the humidifier unit to
achieve a desired output at the humidifier unit exit port.
Inventors: |
Tatkov; Stanislav; (Howick
Auckland, NZ) ; Crone; Christopher Malcolm;
(Auckland, NZ) ; Hawkins; Peter; (Greenlane
Auckland, NZ) ; Han; Jae Chul; (St. Heliers Auckland,
NZ) ; O'Donnell; Kevin Peter; (Eastern Beach
Auckland, NZ) ; Somervell; Andrew Robert Donald;
(Onehunga Auckland, NZ) |
Assignee: |
FISHER & PAYKEL HEATHCARE
LIMITED
EAST TAMAKI AUCKLAND
NZ
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20110120462 A1 |
May 26, 2011 |
|
|
Family ID: |
41377298 |
Appl. No.: |
12/995458 |
Filed: |
May 27, 2009 |
PCT Filed: |
May 27, 2009 |
PCT NO: |
PCT/NZ09/00091 PCKC 00 |
371 Date: |
January 31, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61056335 |
May 27, 2008 |
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Current U.S.
Class: |
128/203.14 |
Current CPC
Class: |
A61M 16/026 20170801;
A61M 16/0012 20140204; A61M 16/0666 20130101; A61M 16/0051
20130101; A61M 16/0875 20130101; A61M 16/0841 20140204; A61M
16/1085 20140204; A61M 16/16 20130101; A61M 16/0465 20130101; A61M
2205/3368 20130101; A61M 16/0069 20140204; A61M 16/1095 20140204;
A61M 16/161 20140204; A61M 16/109 20140204; A61M 16/1075
20130101 |
Class at
Publication: |
128/203.14 |
International
Class: |
A61M 16/16 20060101
A61M016/16 |
Claims
1. A breathing assistance system for delivering a stream of heated,
humidified gases to a user for therapeutic purposes, comprising: a
humidifier unit that has an inlet port and an exit port, said
humidifier unit adapted to in use receive a flow of gases from a
gases source via said inlet port, said humidifier unit further
adapted to hold and heat a volume of water in use, in use said flow
of gases passing through said humidifier unit and becoming heated
and humidified, said heated humidified gases exiting said
humidifier unit via said humidifier unit exit port; an exit port
temperature sensor adapted to measure the temperature of gases
exiting said humidifier unit; an ambient temperature sensor adapted
to measure the temperature of gases at a point before said gases
enter said humidifier unit; a flow sensor adapted to measure the
actual flow rate of said gases stream through said system; and a
controller adapted to receive data from said ambient temperature
sensor relating to the measured temperature, data from said exit
port temperature sensor relating to the measured temperature, and
data from said flow sensor relating to said actual flow rate;
determine a target temperature for said exit port based on at least
the data from said ambient temperature sensor and said flow sensor;
and adjust the power to said humidifier unit to achieve said target
temperature at said humidifier unit exit port.
2. (canceled)
3. A breathing assistance system as claimed in claim 1 wherein said
target temperature is determined from a rule-based system loaded in
said controller.
4. A breathing assistance system as claimed in claim 1 wherein said
target temperature is determined from at least one mathematical
formula loaded in said controller.
5. A breathing assistance system as claimed in claim 1 wherein said
target temperature is determined from a look-up table loaded in
said controller.
6. A breathing assistance system as claimed in claim 1 wherein
achieving said target temperature achieves a target dew point
temperature at said humidifier unit exit port.
7. A breathing assistance system as claimed in claim 6 wherein said
target dew point temperature is in the range 31-39.degree. C.
8. A breathing assistance system as claimed in claim 6 wherein said
user set target dew point temperature provides an absolute humidity
level of substantially 44 mg H.sub.2O/litre of air.
9. A breathing assistance system as claimed in claim 1 wherein said
achieving said target temperature achieves a target absolute
humidity at said humidifier unit exit port.
10. A breathing assistance system as claimed in claim 1 wherein
said achieving said target temperature achieves a relative humidity
at said humidifier unit exit port.
11. A breathing assistance system as claimed in claim 1 wherein
said breathing assistance system further comprises user controls
adapted to enable a user to set a desired user-set flow rate of
gases through said system.
12. A breathing assistance system as claimed in claim 11 wherein
said breathing assistance apparatus further comprises a control
unit adapted to in use receive a flow of gases from a remote
central source, said control unit located in the gases path between
said central source and said humidifier unit, said control unit
receiving said flow of gases and passing said flow on to said
humidifier unit via a gases connection path between said humidifier
unit and said control unit, said user controls adapted to enable a
user to set a desired user-set flow rate through said control
unit.
13. A breathing assistance system as claimed in claim 12 wherein
said control unit further comprises a venturi adapted to mix said
flow of gases from said central source with atmospheric gases
before passing these to said humidifier unit.
14. A breathing assistance system as claimed in claim 11 wherein
said gases source is a blower unit fluidically connected in use to
said humidifier unit, said blower unit having an adjustable,
variable speed fan unit adapted to deliver said flow of gases over
a range of flow rates to said humidifier unit and user controls
adapted to enable a user to set a desired user-set flow rate, said
controller adapted to control the power to said blower unit to
produce said user-set flow rate.
15. A breathing assistance system as claimed in claim 1 wherein
said humidifier unit is a humidifier chamber having a heater base;
said breathing assistance system further comprises a heater plate
adapted to heat the contents of said humidifier chamber by
providing heat energy to said heater base; and said breathing
assistance system further comprising a heater plate temperature
sensor adapted to measure the temperature of said heater plate and
provide this temperature measurement to said controller, said
controller determining said target temperature by assessing all of
said measured temperatures and said measured flow rate.
16. A breathing assistance system as claimed in claim 15 wherein if
the target temperature is achieved at said humidifier unit exit
port and the corresponding heater plate temperature is higher than
a set value stored in the memory of said controller for a given
pre-set time period, said controller assesses that said humidifier
unit is experiencing high convective heat loss and determines said
target temperature according to an altered or different rule set,
mathematical formula or look-up table.
17. A breathing assistance system as claimed in claim 15 wherein
said controller is further adapted to measure the power drawn by
said heater plate for a given pre-set time period and if the power
drawn is higher than a value stored in the memory of said
controller, said controller assesses that said humidifier unit is
experiencing high convective heat loss and determines said target
temperature according to an altered or different control algorithm,
mathematical formula or look-up table.
18. A breathing assistance system as claimed in claim 15 wherein
said controller is further adapted to measure the power drawn by
said heater plate for a given pre-set time period and compare this
to a pre-stored set of values stored in the memory of said
controller, said controller applying an inversely linear correction
factor if the measured power drawn is not substantially similar to
said pre-stored set of values.
19. A breathing assistance apparatus as claimed in claim 18 wherein
said measured data values and said stored data values must be
within +/-2%.
20. A breathing assistance system as claimed in claim 1 wherein
said ambient temperature sensor is located at or close to said
inlet port to measure the temperature of gases substantially as
they enter said humidifier unit.
21. A breathing assistance system as claimed in claim 1 wherein
said ambient temperature sensor is adapted to measure the pre-entry
temperature of gases substantially as they enter said breathing
assistance system, said controller applying a correction factor to
said pre-entry temperature.
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Description
FIELD OF THE INVENTION
[0001] This invention relates to methods and apparatus for
controlling the humidity level and flow rate of gases in a device
that provides a stream of heated, humidified gases to a user for
therapeutic purposes. This invention particularly relates to
methods and apparatus for controlling the humidity of a gases
stream in devices that provide humidified air for: respiratory
humidification therapy, high-flow oxygen therapy, CPAP therapy,
Bi-PAP therapy, OPAP therapy, etc, or humidification of gases used
for insufflation or keyhole surgery.
BACKGROUND
[0002] Devices or systems for providing a humidified gases flow to
a patient for therapeutic purposes are well known in the art.
Systems for providing therapy of this type (for example respiratory
humidification) have a structure where gases are delivered to a
humidifier chamber from a gases source. As the gases pass over the
hot water, or through the heated, humidified air in the humidifier
chamber, they become saturated with water vapour. The heated
humidified gases are then delivered to a user or patient downstream
from the humidifier chamber, via a gases conduit and a user
interface. The gases delivery system can be a modular system that
has been assembled from separate units, with the gases source being
an assisted breathing unit or blower unit. That is, the humidifier
chamber/heater and the blower unit are separate (modular) items.
The modules are in use connected in series via connection conduits
to allow gases to pass from the blower unit to the humidifier unit.
Alternatively, the breathing assistance apparatus can be an
integrated system, where the blower unit and the humidifier unit
are contained within the same housing in use. In both modular and
integrated systems, the gases provided by the blower unit are
generally sourced from the surrounding atmosphere. A third general
form of breathing assistance system, which is typically used in
hospitals, is one where the breathing assistance system receives at
least a portion of the gases which it uses from a central gases
source, typically external to the area of use (e.g. a hospital
room). A gases conduit or similar is connected between an inlet
which is mounted e.g. in the wall of a patients room (or similar).
The gases conduit is either connected directly to the humidifier
chamber in use, or a step-down control unit or similar can be
connected in series between the gases inlet and the humidifier
chamber if required. This type of breathing assistance system is
generally used where a patient or user may require oxygen therapy,
with the oxygen supplied from the central gases source. It is
common for the pure oxygen from the gases source to be blended with
atmospheric air before delivery to the patient or user, for example
by using a venturi located in the step-down control unit. In
systems of the type where at least some of the gases are delivered
from a central source, there is no need for a separate flow
generator or blower--the gases are delivered from the inlet under
pressure, with the step down control unit altering the pressure and
flow to the required level.
[0003] An example of a known, prior art, type of modular system
using atmospheric gases only is shown in FIG. 1.
[0004] In typical integrated and modular systems, the atmospheric
gases are sucked in or otherwise enter a main `blower` or assisted
breathing unit, which provides a gases flow at it's outlet. The
blower unit and the humidifier unit are mated with or otherwise
rigidly connected to the blower unit. For example, the humidifier
unit is mated to the blower unit by a slide-on or push connection,
which ensures that the humidifier unit is rigidly connected to and
held firmly in place on the main blower unit. An example of a
system of this type is the Fisher and Paykel Healthcare `slide-on`
water chamber system shown and described in U.S. Pat. No.
7,111,624. A variation of this design is a slide-on or clip-on
design where the chamber is enclosed inside a portion of the
integrated unit in use. An example of this type of design is
described in WO 2004/112873.
[0005] One of the problems that has been encountered with systems
that provide a flow of heated, humidified gases to a patient via a
gases conduit and an interface is that of adequately controlling
the characteristics of the gas. Clearly, it is desirable to deliver
the gas to the patient (i.e. as it exits the user interface) with
the gas at precisely the right temperature, humidity, flow, and
oxygen fraction (if the patient is undergoing oxygen therapy) to
provide the required therapy. A therapy regime can become
ineffective if the gases are not delivered to the patient with the
correct or required characteristics. Often, the most desirable
situation is to deliver gases that are fully saturated with water
vapour (i.e. at substantially 100% relative humidity) to a user, at
a constant flow rate. Other types or variations of therapy regime
may call for less than 100% relative humidity. Breathing circuits
are not steady-state systems, and it is difficult to ensure the
gases are delivered to a user with substantially the correct
characteristics. It can be difficult to achieve this result over a
range of ambient temperatures, ambient humidity levels, and a range
of gas flows at the point of delivery. The temperature, flow rate
and humidity of a gases stream are all interdependent
characteristics. When one characteristic changes, the others will
also change. A number of external variables can affect the gases
within a breathing circuit and make it difficult to deliver the
gases to the user at substantially the right temperature, flow rate
and humidity. As one example, the delivery conduit between the
patient or user and the humidifier outlet is exposed to ambient
atmospheric conditions, and cooling of the heated, humidified gases
within the conduit can occur as the gas travels along the conduit
between the exit port of the humidifier chamber and the user
interface. This cooling can lead to `rain-out` within the conduit
(that is, condensate forming on the inner surface of the conduit).
Rain-out is extremely undesirable for reasons that are explained in
detail in WO 01/13981.
[0006] In order to assist in achieving delivery of the gases stream
with the gases having the desired characteristics, prior art
systems have used sensors (e.g. temperature and humidity sensors)
located at various positions throughout the breathing circuit.
Thermistors are generally used as temperature sensors, as these are
reliable and inexpensive. Humidity sensors such as the one
described in U.S. Pat. No. 6,895,803 are suitable for use with
systems that deliver heated humidified gases to a user for
therapeutic purposes.
[0007] In order to achieve delivery of the gases to the patient at
the correct temperature and humidity, it is necessary either to
measure or sense the gases characteristics at the point of
delivery, or to calculate or estimate the gases characteristics at
the point of delivery from measurements taken from elsewhere in the
system. In order to directly measure the gases parameters at the
point of delivery, sensors must be located at or close to the point
of delivery--either at the end of the patient conduit or within the
interface. Sensors located at or close to the point of gases
delivery will give the most accurate indication of the gases state.
However, one consideration when designing a breathing circuit is to
ensure that the components used in the breathing circuit can be
repeatedly connected and disconnected to and from each other, with
high reliability. Another consideration is to keep the weight
carried by the patient in use to a minimum, and therefore it is
desirable to keep the number of sensors at the patient end of the
conduit to a minimum, or remove the need for these altogether. It
is also desirable to keep the total number of sensors in the system
to a minimum, in order to reduce costs and complexity (e.g. an
increased number of electrical and pneumatic connections).
[0008] In order to overcome or sidestep the problem or trade-off of
accurate measurement of the gases characteristics vs complexity vs
cost vs weight carried by the patient vs reliability, sensors can
be located at various other points within the system to measure the
parameters of the gas at those points, and the readings from these
sensors can be used by a controller to estimate or calculate the
characteristics of the gases at the point of delivery. The
controller then adjusts the output parameters of the system (e.g.
fan speed, power to the humidifier chamber heater plate, etc)
accordingly. One example of a system and method where this type of
calculation is carried out is disclosed in WO 2001/13981, which
describes an apparatus where there are no sensors at the patient
end of the conduit. A temperature sensor is located proximal to the
heater plate in order to measure the heater plate temperature. The
flow of gases through the humidifier chamber is estimated, and the
appropriate power level for the heater plate is then determined by
a central controller. The controller estimates the power supply to
the heater humidifier plate, and the power required by the conduit
heater wire for achieving optimal temperature and humidity of the
gases delivered to a patient.
[0009] One possible disadvantage of systems and methods which
estimate the gases characteristics (such as the system and method
disclosed in WO 2001/13981) is that the estimations and algorithms
used are not as accurate as is necessary. There are many variable
factors that can detrimentally effect the accuracy of the
calculation algorithms used by the controller. These factors may
not have been taken into consideration when the algorithm was
designed. For example, the apparatus and in particular the
humidifier chamber can be subject to convective heat loss (`draft`)
which is created by external airflows, particularly in ventilated
spaces. The flow velocities of the air vary in magnitude, direction
and fluctuation frequency. Mean air velocities from below 0.05 m/s
up to 0.6 m/s, turbulence intensities from less than 10% up to 70%,
and frequency of velocity fluctuations as high as 2 Hz that
contribute up to 90% of the measured standard deviations of
fluctuating velocity have been identified in the occupied zone of
rooms--for one example, see Volume 13, number 6 of HVAC&R
Research--paper titled: `accuracy limitations for low velocity
measurements and draft assessment in rooms`, by A Melikov, Z
Popiolek, and M. C. G. Silva.
[0010] The system disclosed in WO 2001/13981 is unlikely to be able
to provide the control precision necessary to control humidity
accurately without substantial rainout occurring. A user or
manufacturer may be forced to trade-off delivery of gases at a
lower humidity level, against an increased possibility of rain-out,
against the number of sensors used and their location in the
breathing circuit. For example, when the incoming gas delivered to
the humidifier chamber from the compressor or blower (particularly
in an integrated blower/humidifier breathing assistance system) has
an increased temperature, the chamber temperature should be
accurately compensated to achieve the desired dew point. If the air
coming into the chamber is warm and the air temperature is
increasing with an increase in flow, then the inaccuracy of a set
calculation algorithm will increase.
[0011] It should further be noted that prior art systems frequently
measure/calculate and display the humidifier chamber outlet
temperature. Displaying the temperature reading is often inadequate
for a user to make an informed decision, as the temperature does
not always directly relate to the gases humidity state. This is due
to a number of factors, of which the following are examples, but
not an exhaustive list. [0012] 1. High temperature of the incoming
gas. [0013] 2. Very low or very high flow rate. [0014] 3. Cooling
of the humidifier chamber by convection of the ambient air around
the humidification chamber. [0015] 4. Mixing of outgoing and
incoming gases inside the chamber. [0016] 5. Condensation of water
at the chamber wall or connection tubes particularly at low ambient
temperature conditions. [0017] 6. Problems with accurate
temperature measurements at high humidity (the `wet bulb` effect).
[0018] 7. Variations in the level of the humidity of the incoming
gas.
[0019] Furthermore, a user may not always require gases warmed to
body temperature and 100% humidity. A specific therapy regime may
call for a high or 100% humidity level, but this can be undesirable
for users who use a mask, as the conditioned gas with high humidity
can feel uncomfortable for a user on their skin.
[0020] A further problem in system of this type can be outlined as
follows: It is normal in systems such as those outlined above for
the fan speed (modular and integrated units) or pressure/flow level
(hospital, remote source units) to be set to a constant level, with
the assumption that this will provide a constant flow rate
throughout the system (or alternatively, if using a central gases
source in the system, the flow rate of the incoming gases from the
remote source is assumed to remain constant). A constant flow rate
is desirable for the same or similar reasons as outlined above. A
constant flow rate is also very desirable when using additional or
supplementary oxygen, blending this with atmospheric gases. A
constant flow rate will help to keep the oxygen fraction at the
desired level.
[0021] As the gases characteristics are interdependent, a change in
the flow rate may lead to a significant change in the humidity,
temperature or oxygen fraction of the gases delivered to a user.
However, the flow through the system may be affected by a number of
different interdependent variables which are independent of the
gases source (e.g. the speed of the fan). These can include
increased (or decreased) resistance to flow caused by changes in
the position of the user interface on a user, changes in the way
the delivery conduit is bent in use, etc. The flow rate will also
change if, for example, the interface is changed to a different
size or shape of interface, or a different type of interface
altogether.
[0022] There is therefore a need for a system and method which
provides increased control precision for controlling the humidity,
or temperature, or both, of the gases flow, while at the same time
delivering gases to a patient at the correct temperature, humidity
and pressure for effective therapy. There is also the need for a
system which compensates for changes in the resistance to flow
through the system during use in order to provide a substantially
constant flow rate at the desired level.
SUMMARY OF THE INVENTION
[0023] It is an object of the present invention to provide an
integrated blower/humidifier system that goes some way towards
overcoming the above disadvantages, or which provides users with a
useful choice.
In a first aspect the invention may broadly be said to consist in a
breathing assistance system for delivering a stream of heated,
humidified gases to a user for therapeutic purposes,
comprising;
[0024] a humidifier unit that has an inlet port and an exit port,
said humidifier unit adapted to in use receive a flow of gases from
a gases source via said inlet port, said humidifier unit further
adapted to hold and heat a volume of water in use, in use said flow
of gases passing through said humidifier unit and becoming heated
and humidified, said heated humidified gases exiting said
humidifier unit via said humidifier unit exit port,
[0025] an exit port temperature sensor adapted to measure the
temperature of gases exiting said humidifier unit,
[0026] an ambient temperature sensor adapted to measure the
temperature of gases at a point before said gases enter said
humidifier unit,
[0027] a flow sensor adapted to measure the actual flow rate of
said gases stream through said system,
[0028] a controller adapted to receive data from said ambient
temperature sensor relating to the measured temperature, data from
said exit port temperature sensor relating to the measured
temperature, and data from said flow sensor relating to said actual
flow rate, said controller determining a control output in
response, said control output adjusting the power to said
humidifier unit to achieve a desired output at said humidifier unit
exit port.
In a second aspect the invention may broadly be said to consist in
a breathing assistance system for delivering a stream of heated,
humidified gases to a user for therapeutic purposes,
comprising;
[0029] a humidifier unit that has an inlet port and an exit port,
said humidifier unit adapted to in use receive a flow of gases from
a gases source via said inlet port, said humidifier unit further
adapted to hold and heat a volume of water in use, in use said flow
of gases passing through said humidifier unit and becoming heated
and humidified, said heated humidified gases exiting said
humidifier unit via said humidifier unit exit port,
[0030] a delivery conduit and user interface configured to in use
receive said heated humidified gases from said exit port for
delivery to said user, said delivery conduit having a heater wire
adapted to heat the gases within said conduit,
[0031] a patient end temperature sensor adapted to measure the
temperature of said gases flow at or close to said patient,
[0032] a flow probe adapted to measure the actual flow rate of said
gases stream through said system,
[0033] said breathing assistance system further comprising a
controller adapted to receive data from said patient end
temperature sensor relating to the measured temperature, and data
from said flow probe relating to said actual flow rate, said
controller determining a control output in response, said control
output adjusting the power to at least said heater wire to maintain
or alter the temperature of said flow of gases within said conduit
to achieve a desired patient end temperature and absolute humidity
at said interface.
Preferably said control output relates to a target temperature at
said exit port for a given flow level, and said desired output is a
target temperature, said control output adjusting said power to
said humidifier unit to match said measured temperature at said
exit port with said target temperature. Preferably said control
output is determined from a rule-based system loaded in said
controller. Alternatively said control output is determined from at
least one mathematical formula loaded in said controller.
Alternatively said control output is determined from a look-up
table loaded in said controller. Preferably said desired output is
a target dew point temperature. Preferably said target dew point
temperature is in the range 31-39.degree. C. Preferably said user
set target dew point temperature provides an absolute humidity
level of substantially 44 mg H.sub.20/litre of air. Alternatively
said desired output is a target absolute humidity. Alternatively
said desired output is a target temperature and relative humidity.
Preferably said breathing assistance system also has user controls
adapted to enable a user to set a desired user-set flow rate of
gases through said system. Preferably said breathing assistance
apparatus further comprises a control unit adapted to in use
receive a flow of gases from a remote central source, said control
unit located in the gases path between said central source and said
humidifier unit, said control unit receiving said flow of gases and
passing said flow on to said humidifier unit via a gases connection
path between said humidifier unit and said control unit, said user
controls adapted to enable a user to set a desired user-set flow
rate through said control unit. Preferably said control unit
further comprises a venturi adapted to mix said flow of gases from
said central source with atmospheric gases before passing these to
said humidifier unit. Preferably said gases source is a blower unit
fluidically connected in use to said humidifier unit, said blower
unit having an adjustable, variable speed fan unit adapted to
deliver said flow of gases over a range of flow rates to said
humidifier unit and user controls adapted to enable a user to set a
desired user-set flow rate, said controller adapted to control the
power to said blower unit to produce said user-set flow rate.
Preferably said humidifier unit is a humidifier chamber having a
heater base, and said breathing assistance system further has a
heater plate adapted to heat the contents of said humidifier
chamber by providing heat energy to said heater base,
[0034] said breathing assistance system further having a heater
plate temperature sensor adapted to measure the temperature of said
heater plate and provide this temperature measurement to said
controller, said controller determining said control output by
assessing all of said measured temperatures and said measured flow
rate.
Preferably if a target value of said chamber gases outlet
temperature is reached and the corresponding heater plate
temperature is higher than a set value stored in the memory of said
controller for a given pre-set time period, said controller
assesses that said humidifier unit is experiencing high convective
heat loss and determines said control output according to an
altered or different rule set, mathematical formula or look-up
table. Preferably said controller is further adapted to measure the
power drawn by said heater plate for a given pre-set time period
and if the power drawn is higher than a value stored in the memory
of said controller, said controller assesses that said humidifier
unit is experiencing high convective heat loss and determines said
control output according to an altered or different control
algorithm, mathematical formula or look-up table. Preferably said
controller is further adapted to measure the power drawn by said
heater plate for a given pre-set time period and compare this to a
pre-stored set of values stored in the memory of said controller,
said controller applying an inversely linear correction factor if
the measured power drawn is not substantially similar to said
pre-stored set of values. Preferably said measured data values and
said stored data values must be within +/-2%. Preferably said
ambient temperature sensor is located at or close to said inlet
port to measure the temperature of gases substantially as they
enter said humidifier unit. Alternatively said ambient temperature
sensor is adapted to measure the pre-entry temperature of gases
substantially as they enter said breathing assistance system, said
controller applying a correction factor to said pre-entry
temperature. Preferably said controller is adapted to receive at
least said user set flow rate and said actual flow rate data from
said flow probe or flow sensor, said controller having a coarse
control parameters and fine control parameters, said controller
comparing said user set flow rate and said actual flow rate, said
controller using said fine control parameters to adjust the output
of said fan to match said actual flow rate to said user set flow
rate as long as said actual flow rate matches said user set flow
rate to within a tolerance, the value of said tolerance stored
within said controller, said controller using said coarse control
parameters to adjust the output of said fan to match said actual
flow rate to said user set flow rate if the difference between said
user set flow rate and said actual flow rate is outside said
tolerance. Preferably said coarse control parameters are a first
P.I.D. filter and said fine control parameters are a second P.I.D.
filter. Alternatively said controller further comprises a
compensation filter, a low pass filter, a high pass filter, and a
P.I.D. filter, said signal indicative of actual flow rate from said
flow probe passed in parallel through said low pass filter and said
high pass filter, said low pass filter producing a low pass output
signal, said high pass filter producing a high pass output signal
that is passed through said compensation filter, said low pass
output signal subtracted from said user set flow rate signal and
passed into said P.I.D filter, the output signal from said P.I.D
filter and the output signal from said compensation filter summed
and compared to said user set flow rate, said controller using said
coarse control parameters to adjust the output of said fan to match
said actual flow rate to said user set flow rate if the difference
between the sum of said output signals and the user set flow rate
is outside a pre-set tolerance contained in the memory of said
controller. Alternatively said controller is adapted to receive at
least said user set flow rate and said actual flow rate data from
said flow probe, said controller having a coarse control parameters
and fine control parameters, said controller comparing said user
set flow rate and said actual flow rate, said controller using said
fine control parameters to adjust the output of said fan to match
said actual flow rate to said user set flow rate as long as said
actual flow rate matches said user set flow rate to within a
tolerance, the value of said tolerance stored within said
controller, said controller using said coarse control parameters to
adjust the output of said fan to match said actual flow rate to
said user set flow rate if the difference between said user set
flow rate and said actual flow rate is outside said tolerance.
Alternatively said controller further comprises a compensation
filter, a low pass filter, a high pass filter, and a P.I.D. filter,
said signal indicative of actual flow rate from said flow probe
passed in parallel through said low pass filter and said high pass
filter, said low pass filter producing a low pass output signal,
said high pass filter producing a high pass output signal that is
passed through said compensation filter, said low pass output
signal subtracted from said user set flow rate signal and passed
into said P.I.D filter, the output signal from said P.I.D filter
and the output signal from said compensation filter summed and
compared to said user set flow rate, said controller using said
coarse control parameters to adjust the output of said fan to match
said actual flow rate to said user set flow rate if the difference
between the sum of said output signals and the user set flow rate
is outside a pre-set tolerance contained in the memory of said
controller. Preferably said controller also includes a feedback
signal from said fan to said compensation filter so that the input
signal to said fan unit comprises the output signal from said
P.I.D. filter and the output signal from said compensation filter.
Preferably said actual flow rate data is measured by said at least
one flow probe, said actual flow rate data subtracted from said
user set flow data and a signal indicative of the difference sent
to both said first and second P.I.D. filters, said controller using
either the output of said first P.I.D. filter or said second P.I.D.
filter to adjust the output of said fan to match said actual flow
rate to said user set flow rate. Preferably said flow rate is
sampled at a sample rate of between 20 and 30 Hz. Even more
preferably said sample rate is 25 Hz. Preferably said actual flow
rate data is passed through a first low-pass filter before being
subtracted from said user set flow data. Preferably said first
low-pass filter has a cut-off frequency high enough to allow intra
breath flow variation to pass unattenuated. Preferably said actual
flow rate data is also passed through an averaging filter.
Preferably said averaging filter is a second low pass filter.
Preferably the output of said averaging filter is fed back to said
controller in place of said direct flow data from said flow probe.
Preferably said controller receives said averaged flow from said
averaging filter and compares this to said user set flow rate, said
controller using coarse control parameters to adjust the flow rate
to said user set rate if the difference between said user set flow
rate and said actual flow rate is outside a tolerance value stored
in the memory of said controller, said controller using fine
control parameters if said difference is inside said tolerance.
Preferably said tolerance is 3 L/min. Alternatively said tolerance
is variable, and is a percentage value of said actual flow rate as
measured by said flow probe. Preferably said percentage value is
between 1-3%. Alternatively said percentage value is between 3-5%.
Alternatively said percentage value is between 5-7%. Alternatively
said percentage value is between 7-10%. Preferably said control
unit is particularly adapted to receive oxygen as said gases from
said remote source, said at least one flow probe adapted to measure
said flow rate of gases received from said remote source and pass
said flow rate measurement on to said controller, said controller
adapted to determine the flow rate of said gases from atmosphere
based on the known system dimensions, said controller determining
the fraction of oxygen in said blended air from said flow rate and
said system dimensions. Preferably said control unit is adapted to
receive oxygen as said gases from said remote source, said at least
one flow probe adapted to measure said flow rate of gases received
from said remote source, said system further comprising a second
flow probe adapted to measure the flow rate of said gases received
from atmosphere, said controller determining the fraction of oxygen
in said blended air from said flow rates. Preferably said system is
adapted so that when a user alters said user set flow rate this
alters said oxygen fraction. Preferably said system further has a
display adapted to show chamber outlet dew point temperature.
Alternatively said display is adapted to show the absolute humidity
level of gases exiting said chamber. Alternatively said display is
adapted to show absolute humidity and chamber outlet dew point
temperature. Preferably said breathing assistance system also has a
humidity sensor adapted to measure the humidity of atmospheric
gases entering said breathing assistance system, said controller
receiving data relating to the measured humidity,
[0035] said controller determining said control output by also
using said data relating to the measured humidity.
Preferably said system also has a pressure sensor adapted to
measure the pressure of atmospheric gases entering said breathing
assistance system, said controller receiving data relating to the
measured pressure,
[0036] said controller determining said control output by also
using said data relating to the measured pressure.
Preferably said system further comprises a delivery conduit and
user interface configured to in use receive said heated humidified
gases from said exit port for delivery to said user, said delivery
conduit having a heater wire adapted to heat the gases within said
conduit. Preferably said breathing assistance system further has a
patient end temperature sensor adapted to measure the temperature
of said gases flow at or close to said patient, the measured
patient end temperature fed back to said controller, said
controller adjusting the power to said heater wire to maintain the
temperature of said flow of gases within said conduit. Preferably
said controller receives said measured patient end temperature
data, said controller determining said control output by also using
said data relating to the measured patient end temperature data.
Preferably said controller is further adapted to measure the power
drawn by said heater wire for a given pre-set time period, and if
said power drawn by said heater wire is higher than a value stored
in the memory of said controller, said controller assesses that
said humidifier unit is experiencing high convective heat loss and
determines said control output according to an altered or different
rule set, mathematical formula, or look-up table.
[0037] This invention may also be said broadly to consist in the
parts, elements and features referred to or indicated in the
specification of the application, individually or collectively, and
any or all combinations of any two or more of said parts, elements
or features, and where specific integers are mentioned herein which
have known equivalents in the art to which this invention relates,
such known equivalents are deemed to be incorporated herein as if
individually set forth.
[0038] The term `comprising` as used in this specification means
`consisting at least in part of`, that is to say when interpreting
statements in this specification which include that term, the
features, prefaced by that term in each statement, all need to be
present but other features can also be present.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] One preferred form of the present invention will now be
described with reference to the accompanying drawings in which:
[0040] FIG. 1 shows a schematic view of a user receiving humidified
air from a modular blower/humidifier breathing assistance system of
a known, prior art, type.
[0041] FIG. 2a shows a schematic view of a user receiving
humidified air from one variant of the present invention, with the
user wearing a nasal mask and receiving air from a modular
blower/humidifier breathing assistance system.
[0042] FIG. 2b shows a schematic view of a user receiving
humidified air from another variant of the present invention, where
the user is wearing a nasal cannula and receiving air from a
modular blower/humidifier breathing assistance system.
[0043] FIG. 3 shows a schematic view of a user receiving humidified
air from another variant of the present invention, where the user
is wearing a nasal mask and receiving air from an integrated
blower/humidifier breathing assistance system.
[0044] FIG. 4 shows a schematic view of a user receiving humidified
air from another variant of the present invention, where the user
is wearing a nasal cannula, the breathing assistance system
receiving gases from a central source via a wall inlet and
providing these to a control unit, which provides the gases to a
humidifier chamber in line with and downstream of the control
unit.
[0045] FIG. 5 shows a graphical representation of a data set for
use with the breathing assistance system of FIG. 2 or 3, the graph
showing curves representative of seven different constant flow
rates over a range of ambient atmospheric temperatures, and a range
of target temperatures for a given flow and ambient temperature,
the data loaded into the system controller in use.
[0046] FIG. 6 shows a graphical representation of an alternate data
set for use with the breathing assistance system of FIG. 2, 3 or 4,
the alternative data compared to or used alongside the equivalent
data from the table shown graphically in FIG. 5, the graph lines
showing curves representative of two different steady flow rates
for a range of ambient atmospheric temperatures with little
movement of the ambient air, and a range of target temperatures for
a given flow and ambient temperature, and the same steady flow
rates shown over a range of ambient temperatures with high
convective heat loss from the humidification chamber, the data from
the look-up table loaded into the system controller in use.
[0047] FIG. 7 shows a schematic representation of some of the
connections between a controller suitable for use with the
breathing assistance system of FIG. 2, 3 or 4, and other components
of the preferred form of breathing assistance system as shown in
FIG. 2, 3, or 4.
[0048] FIG. 8a shows a graph of measured experimental data of flow,
dew point, chamber exit or chamber outlet temperature under
conditions of high ambient temperature using a breathing assistance
system such as that shown in FIG. 2, 3 or 4.
[0049] FIG. 8b shows a similar graph to FIG. 8a, for conditions of
low ambient temperature.
[0050] FIG. 9 shows a schematic representation of part of the
programming for a control system that is used by the breathing
assistance system of FIG. 2 or FIG. 3 to adjust the flow rate
through the system so that it remains substantially constant when
the geometry of the system changes, the control mechanism
containing two P.I.D. control filters, one for large deviation and
one for small deviation from the set flow rate, the control
mechanism also containing an averaging filter located in a feedback
path to compare the measured flow with the set flow rate.
[0051] FIG. 10a shows a schematic representation of part of the
programming for a control system that is used by the breathing
assistance system of FIG. 2 or FIG. 3 so that average and intra
breath flow can be controlled with a low-pass filter also
incorporated as part of the programming and used for determining
whether coarse or fine flow control is used.
[0052] FIG. 10b shows a schematic representation of part of the
programming for a control system which incorporates dual feedback
loops for improved flow control in the system of FIG. 2 or FIG. 3,
the dual feedback loops allowing separate control filters, so that
average and intra breath flow can be controlled.
[0053] FIG. 11 shows a schematic diagram of the system of FIG. 10b,
with the addition of a further feedback path from the flow
generator to the compensation filter, to assist in compensating for
the non-linear nature of the breathing system shown in FIGS. 2, 3
and 4.
[0054] FIG. 12 shows a graph of motor speed for a number of example
interfaces, demonstrating that humidity can be controlled to an
appropriate level for either a mask or a nasal cannula (which
require different motor speeds, with the system remaining stable
and producing an appropriate humidity level at both high-speed and
at low-speed).
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0055] A schematic view of a user 2 receiving air from a modular
assisted breathing unit and humidifier system 1 according to a
first variant or embodiment of the invention is shown in FIGS. 2a
and 2b. The system 1 provides a pressurised stream of heated,
humidified gases to the user 2 for therapeutic purposes (e.g. to
reduce the incidence of obstructive sleep apnea, to provide CPAP
therapy, to provide humidification for therapeutic purposes, or
similar). The system 1 is described in detail below.
[0056] The assisted breathing unit or blower unit 3 has an internal
compressor unit, flow generator or fan unit 13--generally this
could be referred to as a flow control mechanism. Air from
atmosphere enters the housing of the blower unit 3 via an
atmospheric inlet 40, and is drawn through the fan unit 13. The
output of the fan unit 13 is adjustable--the fan speed is variable.
The pressurised gases stream exits the fan unit 13 and the blower
unit 3 and travels via a connection conduit 4 to a humidifier
chamber 5, entering the humidifier chamber 5 via an entry port or
inlet port 23. The humidifier chamber 5 in use contains a volume of
water 20. In the preferred embodiment, in use the humidifier
chamber 5 is located on top of a humidifier base unit 21 which has
a heater plate 12. The heater plate 12 is powered to heat the base
of the chamber 5 and thus heat the contents of the chamber 5. As
the water in the chamber 5 is heated it evaporates, and the gases
within the humidifier chamber 5 (above the surface of the water 20)
become heated and humidified. The gases stream entering the
humidifier chamber 5 via inlet port 23 passes over the heated water
(or through these heated, humidified gases--applicable for large
chamber and flow rates) and becomes heated and humidified as it
does so. The gases stream then exits the humidifier chamber 5 via
an exit port or outlet port 9 and enters a delivery conduit 6. When
a `humidifier unit` is referred to in this specification with
reference to the invention, this should be taken to mean at least
the chamber 5, and if appropriate, the base unit 21 and heater
plate 12. The heated, humidified gases pass along the length of the
delivery conduit 6 and are provided to the patient or user 2 via a
user interface 7. The conduit 6 may be heated via a heater wire
(not shown) or similar to help prevent rain-out. The user interface
7 shown in FIG. 2a is a nasal mask which surrounds and covers the
nose of the user 2. However, it should be noted that a nasal
cannula (as shown in FIG. 2b), full face mask, tracheostomy
fitting, or any other suitable user interface could be substituted
for the nasal mask shown. A central controller or control system 8
is located in either the blower casing (controller 8a) or the
humidifier base unit (controller 8b). In modular systems of this
type, it is preferred that a separate blower controller 8a and
humidifier controller 8b are used, and it is most preferred that
the controllers 8a, 8b are connected (e.g. by cables or similar) so
they can communicate with one another in use. The control system 8
receives user input signals via user controls 11 located on either
the humidifier base unit 21, or on the blower unit 3, or both. In
the preferred embodiments the controller 8 also receives input from
sensors located at various points throughout the system 1. FIG. 7
shows a schematic representation of some of the inputs and outputs
to and from the controller 8. It should be noted that not all the
possible connections and inputs and outputs are shown--FIG. 7 is
representative of some of the connections and is a representative
example. The sensors and their locations will be described in more
detail below. In response to the user input from controls 11, and
the signals received from the sensors, the control system 8
determines a control output which in the preferred embodiment sends
signals to adjust the power to the humidifier chamber heater plate
12 and the speed of the fan 13. The programming which determines
how the controller determines the control output will be described
in more detail below.
[0057] A schematic view of the user 2 receiving air from an
integrated blower/humidifier system 100 according to a second form
of the invention is shown in FIG. 3. The system operates in a very
similar manner to the modular system 1 shown in FIG. 2 and
described above, except that the humidifier chamber 105 has been
integrated with the blower unit 103 to form an integrated unit 110.
A pressurised gases stream is provided by fan unit 113 located
inside the casing of the integrated unit 110. The water 120 in the
humidifier chamber 105 is heated by heater plate 112 (which is an
integral part of the structure of the blower unit 103 in this
embodiment). Air enters the humidifier chamber 105 via an entry
port 123, and exits the humidifier chamber 105 via exit port 109.
The gases stream is provided to the user 2 via a delivery conduit
106 and an interface 107. The controller 108 is contained within
the outer shell of the integrated unit 100. User controls 111 are
located on the outer surface of the unit 100.
[0058] A schematic view of the user 2 receiving air from a further
form of breathing assistance system 200 is shown in FIG. 4. The
system 200 can be generally characterised as a remote source
system, and receives air from a remote source via a wall inlet
1000. The wall inlet 1000 is connected via an inlet conduit 201 to
a control unit 202, which receives the gases from the inlet 1000.
The control unit 202 has sensors 250, 260, 280, 290 which measure
the humidity, temperature and pressure and flow respectively of the
incoming gases stream. The gases flow is then provided to a
humidifier chamber 205, with the gases stream heated and humidified
and provided to a user in a similar manner to that outlined above.
It should be noted that when `humidifier unit` is referred to for a
remote source system such as the system 200, this should be taken
to mean as incorporating the control unit 202--the gases from the
remote source can either be connected directly to an inlet, or via
the control unit 202 (in order to reduce pressure or similar), but
the control unit and the humidifier chamber should be interpreted
as belonging to an overall `humidifier unit`. If required, the
system 200 can provide O.sub.2 or an O.sub.2 fraction to the user,
by having the central source as an O.sub.2 source, or by blending
atmospheric air with incoming O.sub.2 from the central source via a
venturi 90 or similar located in the control unit 202. It is
preferred that the control unit 202 also has a valve or a similar
mechanism to act as a flow control mechanism to adjust the flow
rate of gases through the system 200.
Sensors
[0059] The modular and integrated systems 1, 100 and 200 shown in
FIGS. 2, 3 and 4 have sensors located at points throughout the
system. These will be described below in relation to the breathing
assistance system 1.
[0060] The preferred form of modular system 1 as shown in FIG. 2
has at least the following sensors in the following preferred
locations:
[0061] 1) An ambient temperature sensor 60 located within, near, or
on the blower casing, configured or adapted to measure the
temperature of the incoming air from atmosphere. It is most
preferred that temperature sensor 60 is located in the gases stream
after (downstream of) the fan unit 13, and as close to the inlet or
entry to the humidifier chamber as possible.
[0062] 2) A humidifier unit exit port temperature sensor 63 located
either at the chamber exit port 9, or located at the apparatus end
(opposite to the patient end) of the delivery conduit 6. Outlet
temperature sensor 63 is configured or adapted to measure the
temperature of the gases stream as it exits chamber 5 (in either
configuration the exit port temperature sensor 63 can be considered
to be proximal to the chamber exit port 9).
[0063] Similarly, sensors are arranged in substantially the same
locations in the integrated system 100 shown in FIG. 3 and the
system 200 of FIG. 4. For example, for the integrated system of
FIG. 3, an ambient temperature sensor 160 is located within the
blower casing in the gases stream, just before (upstream of) the
humidifier chamber entry port 123. A chamber exit port temperature
sensor 163 is located either at the chamber exit port 109 and is
configured to measure the temperature of the gases stream as it
exits chamber 105 (in either configuration the exit port
temperature sensor 163 can be considered to be proximal to the
chamber exit port 109). Alternatively, this sensor can be located
at the apparatus end (opposite to the patient end) of the delivery
conduit 106, for either embodiment. A similar numbering system is
used for the breathing assistance system shown in FIG. 4--ambient
temperature sensor 260, fan unit 213, chamber exit port temperature
sensor 263 located at the chamber exit port 209, etc.
[0064] It is also preferred that the breathing assistance system 1
(and 100, 200) also has a heater plate temperature sensor 62
located adjacent to the heater plate 12, configured to measure the
temperature of the heater plate. The breathing assistance system(s)
having a heater plate temperature sensor is preferred as it gives
an immediate indication of the state of the heater plate. However,
it is not absolutely necessary to for the system(s) to have the
heater plate temperature sensor in order to reduce the invention to
practice.
[0065] It is also most preferred that the systems also have a flow
probe--flow probe 61 in system 1--located upstream of the fan unit
13 and configured to measure the gases flow. The preferred location
for the flow probe is upstream of the fan unit, although the flow
probe can be located downstream of the fan, or anywhere else
appropriate. Again, it is preferred that a flow probe forms part of
the system, but it is not absolutely necessary for a flow probe to
be part of the system to reduce the invention to practice.
[0066] The layout and operation of the breathing assistance system
1 will now be described below in detail. The operation and layout
of the systems 100 and 200 is substantially the same, and will not
be described in detail except where necessary.
[0067] For the breathing assistance system 1, the readings from all
of the sensors are fed back to the control system 8. The control
system 8 also receives input from the user controls 11.
[0068] Further alternative additional sensors and their layout will
be described in more detail later.
Humidity Control Method
[0069] In the most preferred embodiment, the control system 8 has
at least one data set pre-loaded into the controller. The data that
forms the data set is pre-measured or pre-calculated under
controlled conditions (e.g. in a test area or laboratory) for a
specific system configuration with specific components (e.g. system
1 or system 100, or system 200, with a particular, specific blower
unit and humidifier unit used to gather the data). The data is
gathered under a number of condition ranges that will typically be
encountered in use, with the pre-measured (pre-set) data then being
loaded as integral software or hardware into the controller 8 for
the production systems, or as data to be used in e.g. a fuzzy logic
algorithm for humidity control.
[0070] A data set particularly suitable for use with system 1 is
shown as a graph in FIG. 5. The X-axis shows a range of ambient
temperatures, from 18.degree. C. to 35.degree. C. In use, the
ambient temperature of the gases in the breathing assistance system
before or upstream of the chamber 5 is measured by the ambient
temperature sensor 60, and the ambient temperature data is relayed
to the controller 8. It is most preferred that the temperature
sensor 60 measures the ambient temperature of the gases just before
the gases enter the chamber 5. In order to create the data set, a
typical system 1 is placed in an environment where the ambient
temperature can be kept at a known, constant level over a range of
temperatures.
[0071] In the preferred form in use, a user chooses a flow rate by
adjusting the controls 11. The controller 8 receives the input from
the user controls 11 and adjusts the fan speed to substantially
match this requested flow rate (either by altering the speed of the
fan to a speed that is known to substantially correspond to the
required flow for the particular breathing circuit configuration,
or by measuring the flow using flow probe 61 and using a feedback
mechanism via controller 8 to adjust the flow rate to the level
required or requested). Seven different constant flow rates are
shown in the graph of FIG. 5, for seven different constant fan
speeds. The lines 70-76 correspond to different flow rates as
follows: Line 70--a flow rate 15 litres/minute. Line 71--a flow
rate of 20 litres/minute. Line 72--a flow rate of 25 litres/minute.
Line 73--a flow rate of 30 litres/minute. Line 74--a flow rate of
35 litres/minute. Line 75--a flow rate of 40 litres/minute. Line
76--a flow rate of 45 litres/minute.
[0072] The Y-axis shows a range of target chamber temperatures.
That is, for any given fan speed (flow rate and pressure), and any
given ambient temperature, there is a `best`, or `ideal` target
outlet temperature for the gases in the chamber 5 above the water
20--the target outlet temperature as shown on the Y-axis. This
`ideal` temperature is the dew point temperature for a given
constant flow and constant ambient temperature. That is, the
temperature at which the gases can exit the chamber 5 at the
required saturation (required level of humidity) and then be
delivered to the user 2 at the correct temperature and pressure for
effective therapy. As the gases exit the chamber 5, the gases
temperature is measured by the chamber exit port temperature sensor
63. The controller 8 is adapted to receive the temperature data
measured by the chamber exit temperature sensor 63 and the data
relating to the temperature of the gases entering the chamber 5 (as
measured by ambient temperature sensor 60). The flow rate has been
previously set to a constant value, as outlined above, so the
controller 8 already `knows` the constant flow rate. As the
controller 8 `knows` both the flow rate and the ambient
temperature, it can, for example, look up the `ideal` target outlet
temperature from the range incorporated into the pre-loaded data
set (e.g. the data shown graphically in FIG. 5). The controller 8
then compares the measured value of chamber exit temperature to the
`ideal` target chamber temperature for the given, known flow rate
and ambient temperature. If the measured value of target
temperature does not match the `ideal` target value, the controller
8 generates or determines a suitable control output, and adjusts
the power to the heater plate accordingly, either increasing the
power to increase the temperature of the gases within the chamber
5, or decreasing the power to decrease the gases temperature. The
controller 8 adjusts the power in this manner in order to match the
temperature measured at the outlet or exit port with the required
target temperature. In the preferred embodiment, the mechanism by
which the controller 8 adjusts the output characteristics is via a
Proportional-Integral-Derivative controller (P.I.D. controller) or
any one of a number of similar mechanisms which are known in the
art.
[0073] The controller could also generate or determine a suitable
control output by, for example, using a fuzzy logic control
algorithm loaded into the controller 8, or mathematical formulae
which utilise the measured temperature and flow data as variables
in the equations.
[0074] Examples of mathematical formulae are shown below. These
correspond generally to the data shown graphically in FIG. 5, for
the range of flow rates from 15 to 45 litres/min.
TABLE-US-00001 45 T.sub.CS = -0.0005T.sub.amb.sup.4 +
0.055T.sub.amb.sup.3 - 2.1234T.sub.amb.sup.2 + 35.785T.sub.amb -
186.31 40 T.sub.CS = -0.0005T.sub.amb.sup.4 + 0.0578T.sub.amb.sup.3
- 2.2311T.sub.amb.sup.2 + 37.554T.sub.amb - 196.98 35 T.sub.CS =
-0.0006T.sub.amb.sup.4 + 0.0625T.sub.amb.sup.3 -
2.4283T.sub.amb.sup.2 + 41.178T.sub.amb - 221.29 30 T.sub.CS =
-0.0006T.sub.amb.sup.4 + 0.0669T.sub.amb.sup.3 -
2.6156T.sub.amb.sup.2 + 44.613T.sub.amb - 244.25 25 T.sub.CS =
-0.0006T.sub.amb.sup.4 + 0.0696T.sub.amb.sup.3 -
2.7315T.sub.amb.sup.2 + 46.76T.sub.amb - 258.75 20 T.sub.CS =
-0.0007T.sub.amb.sup.4 + 0.0736T.sub.amb.sup.3 -
2.8942T.sub.amb.sup.2 + 49.651T.sub.amb - 277.53 15 T.sub.CS =
-0.0007T.sub.amb.sup.4 + 0.0776T.sub.amb.sup.3 -
3.0612T.sub.amb.sup.2 + 52.611T.sub.amb - 296.71
[0075] Example: the therapy regime of a user 2 specifies a certain
flow rate and pressure, for example a flow of 45 litres/min. The
speed of the blower or fan unit 13 is set (via the controls 11) to
deliver gases at this flow rate. If a flow probe 61 is part of the
system, this flow rate can be dynamically adjusted by feeding back
a real-time flow reading from the flow sensor or flow probe 61 to
the controller 8, with the controller 8 adjusting the fan speed as
necessary. This can be done via a P.I.D. controller that comprises
part of the controls 8 as described in detail below, or similar. It
is preferred that the flow rate is dynamically adjusted and
monitored. However, if a flow probe is not part of the system, then
the flow rate is assumed or calculated from the fan speed, and is
assumed to be constant for a constant fan power level. The flow
rate of 45 litres/minute is shown by line 76 on the graph of FIG.
5. In this example, the user 2 is sleeping in a bedroom having an
ambient temperature of substantially 30.degree. C. Air at
30.degree. C. enters the breathing assistance apparatus and as it
passes through the fan and connecting passages within the casing,
it warms up slightly. The temperature of the air just before it
enters the humidifier chamber is measured by the ambient
temperature sensor 60. As the ambient temperature and the flow rate
are known, the controller 8 can calculate the required target
temperature, as shown on the Y-axis of the graph of FIG. 5. For
this particular example, it can be seen that the chamber target
temperature is 42.degree. C. The chamber exit temperature sensor 63
measures the temperature of the gases as they exit the chamber 5
(the gases temperature at the exit point will be substantially the
same temperature as the gases in the space above the chamber
contents 20). If the gases temperature as measured by the chamber
exit temperature sensor 63 is not 42.degree. C., then the
controller 8 determines and generates a suitable control output
which alters the power to the heater plate 12 accordingly. As
above, if the ambient temperature as measured by the ambient
temperature sensor 60 changes, this can be fed back to the
controller 8 and the outputs altered as appropriate using a P.I.D.
control algorithm or similar.
[0076] One of the advantages of this system over the systems
disclosed in the prior art is as follows: in prior art systems, as
the ambient temperatures approach the target dew point temperature,
the heater plate will draw less power and not raise the temperature
of the water in the humidifier chamber as much. Therefore the gases
will tend not be fully saturated as they exit the chamber. The
method outlined above overcomes this problem by using values of
ambient temperature or more preferably chamber inlet temperature,
chamber exit temperature and flow rate for a system of a known
configuration, in order to produce a target chamber exit
temperature which is considered to be substantially the best or
`ideal` temperature for gases saturation and delivery to a user for
a set flow rate and a particular ambient temperature.
[0077] Another advantage is that the system 1 can accurately
control the humidity level without the need for an accurate
humidity sensor.
[0078] Another advantage is that when gas is delivered to the
humidifier chamber from the compressor or blower, and this incoming
gas has an increased temperature, the chamber temperature can be
accurately compensated to achieve the desired dew point. This is
particularly advantageous if the air or gases entering the chamber
are warm, and also in situations when the temperature increases as
the flow increases. In operation, any flow generator causes an
increase in air temperature between the inlet from atmosphere and
the outlet. This change in temperature can be more pronounced in
some types of flow generator. The temperature of components of the
system can change between the time at which the system is first
activated and some time afterwards (e.g. over a reasonably
prolonged period of time such as 1-2 hours). That is, components of
the system can heat up as the system is operating, with the system
taking some time to reach a steady state of operation. If these
components are located in or adjacent to the air path between the
point at which air enters the system, and the point at which the
air enters the chamber, then the temperature of these gases is
going to change--there is going to be some heat transfer from these
components to the gases as the gases travel along this path. It can
therefore be seen that measuring the temperature of the gases as
they enter the chamber reduces the likelihood of introducing a
temperature measurement error into the control calculations, as the
temperature of the gases at the point of entry to the system when
the system has reaches a steady state of operation may be different
from the temperature of the gases at the point of entry to the
chamber. However, it has generally been found that although it is
most preferable to measure gases temperature at the point of entry
to the chamber, it is also acceptable in most circumstances to
measure atmospheric gases temperature.
[0079] The method described above is substantially similar for the
integrated apparatus 100, or the apparatus 200, although the
pre-set or pre-measured and pre-loaded values in the look-up table
may differ as the apparatus has a slightly different configuration.
In other forms, the user could choose a pressure rate (and the data
set would be modified for pressure values rather than flow
values).
[0080] The apparatus and method described above has been found to
provide improved control of the gases characteristics at the point
of delivery to the user 2, over systems and methods known in the
prior art. The system and method described above goes some way
towards overcoming the problems with prior art methods and
apparatus. The system and method described above controls the
output characteristics with the aim of producing gases at the
chamber exit which are fully saturated--that is, the gases exiting
the chamber are at dew point or very close to dew point for a given
temperature. The system output characteristics are varied for the
target dew point temperature, rather than the chamber exit
temperature.
[0081] If the system has a user display, the dew point (or
alternatively, the absolute humidity, or both dew point and
absolute humidity) can be displayed rather than the chamber outlet
temperature. As outlined above, the chamber outlet temperature can
be an inaccurate indication of the humidity level of the gases
exiting the humidifier chamber. This has been experimentally
verified with a modular system substantially similar to that of
FIG. 2. Data was measured over a full range of flow rates, from
approximately 15 litres/minute to approximately 45 litres/minute.
The chamber outlet temperature and the dew point at the chamber
outlet formed part of the measured data. The data was measured for
one substantially constant ambient temperature (although this was
also measured throughout the test to remove uncertainty). The data
collected is shown graphically in FIG. 8a and FIG. 8b, which show
flow rate on the Y-axis against time on the X-axis. In the graph of
FIG. 8a, the data was gathered for conditions of high ambient
temperature. The measured flow rates are shown on the graph by the
points 801. Line 802 shows the ambient temperature. Line 803 shows
the measured chamber outlet temperature. Line 804a shows the
measured dew point (Td measured). Line 805a shows the displayed dew
point (Td displayed). As can be seen, the ambient temperature
remains substantially the same (increasing slightly with time). The
chamber outlet temperature changes from 39.degree. C. to 41.degree.
C. The actual measured outlet dew point fluctuates around a
substantially constant level. However, these fluctuations or
variations mostly occur during flow transitions. The displayed dew
point remains constant for the entire flow range.
[0082] FIG. 8b shows a similar graph to FIG. 8a, but for conditions
of low ambient temperature (that is, 18-20.degree. C.) and flow
rates over the range 45-15 Litres/min. The chamber outlet
temperature is not displayed as it is very close to dew point. It
should be noted that in the preferred form, dew point is displayed
when the temperature reaches 30.degree. C. only. Patients should
not use the humidifier when humidity is too low. It can be seen
that ambient temperature oscillations have caused transient
behaviour to appear in the measured dew point. However, despite
this, the displayed dew point (Td displayed) as shown by line 805b
can be seen to be `tracking` the actual dew point (Td measured as
shown by line 804b) very consistently. It should be noted that at
12 minutes, the flow rate was turned briefly from 45 Litres/min to
15 Litres/min, causing a small overshoot, as can be seen on the
graph of FIG. 8b. At high flows of 45-40 Litres/min, the heater
plate could not maintain the targeted temperature and the humidity
output was lower than Td 37.degree. C. This is reflected in the
displayed dew point.
[0083] Further preferred variations and embodiments will now be
described, which add to the improved control of the gases
characteristics.
Further Alternative Sensor Layouts
[0084] In a variant of the apparatus and method outlined above, the
system (system 1 or system 100 or system 200) also has additional
sensors as outlined below.
[0085] 1) A patient end temperature sensor 15 (or 115 or 215) is
located at the patient end of the delivery conduit 6 (or
alternatively in or on the interface 7). That is, at or close to
the patient or point of delivery. When read in this specification,
`patient end` or `user end` should be taken to mean either close to
the user end of the delivery conduit (e.g. delivery conduit 6), or
in or on the patient interface 7. This applies unless a specific
location is otherwise stated. In either configuration, patient end
temperature sensor 15 can be considered to be at or close to the
user or patient 2. The reading from the patient end temperature
sensor 15 is fed back to the controller 8 and is used to ensure
that the temperature of the gases at the point of delivery
substantially matches the target patient temperature of the gases
at the chamber exit (the target patient temperature is the target
dew point temperature at the chamber exit). If the reading from the
patient end temperature sensor 15 indicates that the gases
temperature is dropping as it travels the length of the delivery
conduit 6, then the controller 8 can increase the power to the
conduit heater wire (shown as wire 75 on FIG. 2a--not shown but
present in the alternative preferred forms of breathing assistance
system 200 and 400 shown in FIGS. 3 and 4, and the system shown in
FIG. 2b) to maintain the gases temperature. If the power available
to the conduit heater wire 75 is not capable of allowing the gases
at the point of delivery to equal the dew point temperature at the
chamber exit 9 then the controller 8 lowers the target chamber exit
temperature (to lower the dew point temperature). The controller 8
lowers the chamber exit temperature to a level at or close to the
maximum gases temperature the conduit heater wire is able to
deliver to the patient as measured by the patient end temperature
sensor 15. The controller 8 is loaded with a predetermined data
set, and adjusts the power to the heater plate, or the conduit
heater wire, or both, by using this data (which is similar to that
shown in graphical form in FIG. 5). For a constant flow level and
for a measured ambient temperature as measured by ambient
temperature sensor 60 (which may change), there is an ideal patient
end temperature. The controller 8 adjusts the power output or
outputs of the heater plate and the conduit to match the
temperature at the patient end of the conduit (as measured by
temperature sensor 15) with this ideal temperature.
[0086] The above method can be further refined for accuracy if
other conditions of the gases in the system are known--the gases
conditions. For example, if the humidity level of the incoming
gases to the blower is known, or the gases pressure of the incoming
gases. In order to achieve this, alternative embodiments of the
systems 1, 100 and 200 described above can also have a gases
condition sensor located in the incoming gas path (e.g. a humidity
sensor or a pressure sensor). For the modular system 1, a humidity
sensor 50 is shown located proximal to the atmospheric inlet 40.
For the integrated system 100, this is shown as humidity sensor 150
(and so on). In a similar fashion to the control methods outlined
above, the controller 8 is pre-loaded with a humidity level data
set. For a constant flow rate, and known ambient or external
humidity level, there is an ideal gases temperature at the chamber
exit (or at the point of delivery to a user). The data set contains
these ideal values for a range of ambient humidities and flow
rates, similar to the values shown in graphical form in FIG. 5. The
controller 8 adjusts the power output of the heater plate, or the
heater wire, or both, to match the measured chamber exit
temperature (or patient end temperature) with the `ideal`
temperature retrieved from the data set in the memory of the
controller). In a similar manner, the above method can be refined
for accuracy if the pressure level of the incoming gases to the
humidification chamber blower is known, locating a pressure sensor
in the incoming gas path to the humidification chamber (pressure
sensor 80 shown in the incoming gases path in FIG. 2 for the
modular system. Pressure sensor 180 is shown in the incoming gases
path in FIG. 3 for the integrated system. Pressure sensor 280 is
shown in the incoming gases path in FIG. 4 for the central gases
source system). It should be noted that if the data for the data
set was plotted graphically for conditions of constant flow,
ambient temperature and another gases condition (e.g. humidity or
pressure), the graphs would be required to be plotted on three
axes--X, Y and Z--the graphs would be `three-dimensional` when
plotted.
[0087] A further variation on the layout or construction of the
breathing assistance system is as outlined below:
[0088] It is intended in some embodiments that the gases exit the
chamber at 41.degree. C. As the gases pass along the main delivery
tube or conduit towards the interface, they are heated from
41.degree. C. at the chamber exit to 44.degree. C. at the end of
the main delivery hose 6. At the end of the main delivery hose the
gases enters a smaller secondary, unheated delivery hose--e.g. 6a
as shown on FIG. 2b. As they pass through the secondary hose 6a the
gases cool from a temperature of 44.degree. C., to 37.degree. C. as
they enter the user interface 7. 37.degree. C. is considered to be
the optimum delivery temperature for the patient.
[0089] A further refinement of the method outlined above, with or
without the additional sensors, will now be described.
Compensating for Convective Heat Loss and Heat Gain of Flow
Generators
[0090] As outlined in the prior art section, one problem that is
known in the art is that of accurately controlling the output
characteristics of a system when there are a large number of
variables which can affect the output characteristics. It has been
found that one of the variables that has an effect on the gases
output characteristics is convective heat loss from the humidifier
chamber 5. This convection can be caused by natural factors such as
temperature gradients in the room--"natural or free convection" or
by forced movement of air--"forced convection". Forced convection
could for example be caused by a ventilator or an air conditioner.
Convection cooling of the humidifier chamber can substantially
affect the dew point temperature at the humidifier chamber outlet.
A flow of air over the outside surfaces of the humidifier
chamber--e.g. chamber 5 of system 1--will cause the temperature
inside the chamber to drop. In order to compensate for this, more
power is required at the heater plate to increase the temperature
of the contents of the chamber 5. The output temperature at the
chamber outlet is measured by outlet temperature sensor 63, and the
temperature loss will be `seen` by the controller 8 as it records a
drop in temperature at the chamber outlet. The controller 8 will
increase the power to the heater plate 12 to compensate for this
(with a corresponding increase in heater plate temperature measured
by the heater plate temperature sensor 62). The effect of this
increase in power is to increase the heat transfer ratio from water
to gas and the partial water pressure of gas inside the chamber,
and consequently there is an increase in the dew point
temperature.
[0091] Evaporation of non-boiling water is governed by Low Mass
Transfer Rate Theory and mass (water) transfer directly related to
heat transfer. So the evaporation depends on the temperature of the
incoming gas (and less so on its humidity), temperature of water,
flow and pressure. Flow determines not only flow of gas over water
but also the movement of water. For example, stirring (forced
convection) of water will increase the evaporation. The evaporation
rate is higher during a transition mode of a heater plate
controller. The transition mode is characterized by larger
oscillations of temperature in the heater plate and likely causes
an increased turbulence (free convection) in water by raising the
Nusselt number and its mass transfer analogue the Sherwood number.
This is more noticeable at high ambient temperature, or more
particularly under conditions where gases entering the humidifier
are at a high temperature, and when chamber outlet gas temperature
is significantly higher than dew point. Convective heat loss causes
dew point to increase close to the temperature of the gas.
[0092] Elevated chamber outlet temperature over dew point causes
instability in the control system. Any fluctuations of flow or
convective heat loss will cause a quick increase in mass (water)
transfer and subsequently humidity of the gas. This instability is
illustrated in FIG. 8a where measured dew point (804) of the air at
high ambient temperature cycles while measured temperature at the
chamber outlet (803) remains relatively stable.
[0093] This is a typical problem of humidity output control in
respiratory support devices that have incorporated both a flow
generator and humidifier (such as CPAP blower, BiPAP or
non-invasive ventilators etc--see FIGS. 1, 2 and 3 for example) and
have a typically targeted dew point at 31-32 degrees, rather than
dew point close to a body temperature of 37.degree. C. (high
humidity with dew point 37.degree. C. is typically used in high
flow therapy and invasive ventilation). The flow generator will
cause the temperature at the chamber inlet to be increased above
usual ambient temperature (22-24.degree. C.) by several degrees.
The inlet temperature may become very close to or even exceed
31-32.degree. C. Increased ambient (atmospheric) temperature
significantly aggravates the problem. The increased chamber inlet
temperature requires air to be heated to approximately
36-41.degree. C. or even higher (depending on the flow rate) to
achieve a dew point of 31-32.degree. C. The patients' physiological
breathing or mechanical ventilation may also affect flow in the
humidification chamber and as a result exposure time of air in the
chamber. All these conditions combine to produce variable humidity
output at the chamber outlet. If the humidification chamber is
exposed to environment, which is usually the case for practicality,
the convection heat loss can also significantly alter the humidity
output.
[0094] The convective heat loss (`draft`) is created by airflows
over and around the ventilation equipment, and particularly the
humidifier chamber. This can be particularly significant in designs
where the chamber is at least partially exposed, particularly in
ventilated spaces. The flow velocities of the air vary in
magnitude, direction and fluctuation frequency. Mean air velocities
from below 0.05 m/s up to 0.6 m/s, turbulence intensities from less
than 10% up to 70%, and frequency of velocity fluctuations as high
as 2 Hz that contribute up to 90% of the measured standard
deviations of fluctuating velocity have been identified in the
occupied zone of rooms.
[0095] The convective heat loss can also be estimated by measuring
flow intensity or turbulence intensity (or both) over the chamber.
This can be achieved using thermal, laser or sonic anemometry, with
sensors mounted on the equipment (e.g. the humidifier base unit 21)
so as to measure the flow or turbulence intensity at or close to
the humidifier chamber 5.
[0096] For precision humidity control, compensation for convective
heat loss is desirable. This compensation is made easier if the
controller 8 has the advantage of a `convection compensation` data
set or sets to rely on, or if the controller has the advantage of
an alternative `convection compensation` method. The controller
could be programmed with a fuzzy-logic type rule-based system.
[0097] The data set shown graphically in FIG. 5 is calculated under
conditions where there is little to no convective heat loss. This
data is suitable for use under conditions where there is low
movement of the ambient air. In alternative forms, or variants of
the apparatus and method outlined above, the controller 8 will
switch to using alternative data as input when the convective heat
loss reaches a certain level--for example, if the controller 8
notes a large step change in the heater plate temperature as
measured by the heater plate temperature sensor 62. For example,
the data will be used as input for a fuzzy logic control algorithm,
a mathematical formula or formulae, or similar.
[0098] FIG. 6 shows part of the data for use if or when ambient
conditions change during use to a `high convection` condition--if
during use there is a flow of air over the apparatus, and in
particular the humidifier chamber, and as a consequence there is a
change from a low convective heat loss condition to a high
convective heat loss condition. The alternate data of FIG. 6 is
created in the same way as the table shown in FIG. 5, but the
pre-measured and pre-loaded conditions (flow and ambient
temperature) are for a system where at least the chamber 5 (or 105
or 205) is experiencing a high level of convective heat loss. The
target temperature changes accordingly. In FIG. 6, part of the
alternative data for use in a `high convective heat loss` condition
is shown. Two curves 501 and 502 are shown, representative of a
steady flow rate of 15 litres/minute (501) and 45 litres/minute
(502). A range of ambient temperatures (X-axis) and a range of
target chamber exit temperatures for a given steady flow rate and
ambient temperature are shown (Y-axis), in a similar manner to the
data shown in FIG. 5. For the purposes of comparison, the two
equivalent steady flow lines (15 litres/minute and 45
litres/minute) from FIG. 5 are also shown on the graph as lines 503
(15 litres/minute) and 504 (45 litres/minute). It can be seen that
when the apparatus is subject to a `high-flow` condition, the
target chamber outlet temperature as shown on the Y-axis is lower
than when the apparatus is subject to a `low-draft` or low level of
convective heat loss condition.
[0099] Similarly, alternate rule sets can be calculated and
pre-loaded into the controller 8. The controller can switch between
alternate fuzzy logic rule-sets depending on the ambient conditions
as measured or assessed by the method(s) outlined above--for
example when the convective heat loss reaches a certain level
assessed by the controller 8 noting a large step change in the
heater plate temperature as measured by the heater plate
temperature sensor 62.
[0100] In order for the controller 8 to assess whether it should be
using data representative of low convective heat loss or high
convective heat loss, an assessment of the heat loss is required.
In the preferred embodiment, this is calculated from the power
required at the heater plate 12 to maintain the correct chamber
exit temperature. The controller 8 is pre-loaded with data values
of heater plate power for known ambient temperatures and flow rates
(alternatively the controller utilises fuzzy logic rule sets). The
controller 8 assesses whether the humidifier chamber is operating
in a condition of high convective heat loss, or a condition of low
convective heat loss, and adjusts or alters it's control output
accordingly (e.g. by utilising the fuzzy logic rule sets to change
operating condition). The condition of `highest convective heat
loss` is defined as the condition (fast moving air) when the
controlled chamber outlet temperature is close to dew point and
further cooling of the chamber does not increase the humidity. `Low
convective heat loss` is defined as the condition (still air) when
the controlled chamber outlet temperature is raised above the dew
point temperature. This is explained further below:
[0101] Normally the controller 8 uses an algorithm or rule set of
`low convective heat loss` (still air, or low convective heat
loss). When the chamber 5 is cooled from outside by convection
(`high convective heat loss`) the humidity output will increase.
The target chamber outlet temperature for the method outlined above
(i.e. using the data shown in FIG. 5) uses look up table data (or a
rule set) that corresponds to a heater plate temperature range
and/or duty cycle of the heater plate. The controller 8 will switch
to data representative of `high convective heat loss` if a target
value of the chamber gas outlet temperature is reached and the
corresponding heater plate temperature is higher than a set limit
for a given time period (this change could also be incorporated as
one of the rules in a fuzzy logic rule set). It should be noted
that if a system is used that does not have a heater plate
temperature sensor, the heater plate power duty cycle can be used
instead of the heater plate temperature to calculate the switchover
point--that is, if a target chamber gas outlet temperature is
reached and the power drawn by said heater plate is higher than a
set value for a given time period.
[0102] The controller 8 will decrease the target chamber gas outlet
temperature by an appropriate value.
[0103] Example: In the preferred embodiment, for the system 100 of
FIG. 3, if a target value of 39.5.degree. C. of the chamber gas
outlet temperature is reached and the corresponding heater plate
temperature (or calculated power) is higher than 60-65.degree. C.
for five minutes, the controller 8 will determine a control output
that decreases the target chamber gas outlet temperature by
0.25.degree. C.
[0104] This new value also has a new corresponding heater plate
temperature and/or duty cycle (i.e. chamber gas outlet temperature
38.4.degree. C. and heated plate temperature 87.degree. C.). So,
the targeted dew point temperature is titrated until it has proper
corresponding heated plate temperature (by a fuzzy logic algorithm
in the controller 8). If the heater plate temperature is
significantly higher than the corresponding chamber gas outlet
temperature then the new targeted value is approached quicker. For
example, if the heater plate temperature is more than 10.degree. C.
higher then the new targeted value is reached in less time (i.e.
0.5.degree. C. lower) etc. This drop of the targeted chamber gas
outlet temperature may vary according to flow and/or ambient/gas
chamber inlet temperature. For example, at a flow rate of 45
Litres/minute and an ambient temperature of 23.degree. C. this drop
can be of 0.1.degree. C. for every 5.degree. C. of heater plate
temperature. At an ambient temperature 30.degree. C. it can be
0.7.degree. C. for every 5.degree. C. of the heater plate
temperature. Moreover, the drop of the target temperature can be
non-linear.
[0105] In alternative embodiments, the heater plate temperature,
the heater plate duty cycle, the heater plate power, the duty cycle
of the heated tube, or the heated tube power can be used for
estimation of the convective heat losses. The heated tube has a
larger surface area and will therefore react quicker to convection
changes.
[0106] The same principle as outlined above is applied in reverse
when the convective heat loss is decreasing after it has increased.
Time limits and steps of the chamber gas outlet temperature
increase or decrease may vary.
[0107] The displayed dew point can be corrected in a way that
tracks actual dew point during the transition time.
[0108] In other alternate embodiments, multiple sets of data can be
used for different levels of convective heat loss, with the
controller 8 using one, some or all of the data sets to determine
the control output for different convective heat loss ranges, for
example by using fuzzy logic control algorithms, mathematical
formulae or similar.
[0109] In yet another alternative embodiment, the use of multiple
data sets can be avoided by using a single data set, and modifying
the target chamber outlet temperatures as follows. If the flow
rate, the ambient temperature and the heater plate power use or
heater plate temperature are known, the target chamber outlet
temperature can be modified according to the (known and changing)
level of heater plate power (or temperature) for any given ambient
temperature and flow rate. In this way, the level of `draft` or
convective heat loss, for example, can be calculated from heater
plate power used. The target chamber outlet temperature is modified
to provide accurate dew point control for a range of convective
heat loss conditions, by applying a correction factor or correction
algorithm to the data in e.g. the data set used to create the
graphs of FIG. 5. For example, if using heater plate power, the
calculation can be made as follows: The required heater plate power
for any given target chamber outlet temperature and flow rate for
low convective heat loss conditions is known, and these values are
stored in the memory of the controller 8. In use, the controller 8
receives data relating to the power used by the heater plate, and
compares this to the stored data. If the measured data values and
the stored data values are not substantially similar (within +/-2%
in the preferred form), the controller applies an inversely linear
correction factor. For example, if the measured heater plate power
is 10% greater than the stored values (indicative of a high
convective heat loss condition), the controller decreases the
target chamber outlet temperature by 10%.
[0110] It should be noted that heater plate temperature or any of
the other methods outlined above (e.g. heater plate temperature,
conduit power, etc) could be used instead of the heater plate power
as outlined in the example above.
[0111] In a similar fashion, if one or more of the conditions of
the gases is known, then a correction algorithm or correction
factor can be applied to the (ambient condition) data stored in the
memory of the controller 8. The ambient conditions under which the
data was measured and loaded are known (e.g. humidity and
pressure). If the measured gases condition deviates from these base
line conditions by a certain percentage (e.g. more than 2%), then
the controller can apply a correction factor to the target chamber
outlet temperature.
[0112] In the embodiments of a coupled blower and humidifier
presented schematically in FIGS. 1, 2 and 3, the chamber inlet
temperature will usually be augmented with an increase of flow, or
pressure, or both, from a flow generator. A fuzzy logic algorithm
or algorithms can be used to define the corrected chamber inlet
temperature according to ambient temperature or chamber entry/inlet
temperature, and motor speed. An increase in the motor speed is
usually accompanied by an increase of the chamber inlet
temperature. Furthermore the known motor speed can be used by the
controller for defining humidity and temperature regimes according
to a known interface attached at the patient end of the delivery
conduit. For example, the lower motor speed associated with a mask
interface (as opposed to a nasal cannula) can be used in the
algorithm to control humidity output from the system to an
appropriate level for a mask. When a mask is used, a dew point of
31.degree. C. is required. A small or large nasal cannula, or a
tracheostomy fitting, require a dew point of 37.degree. C. This is
shown in FIG. 12, which shows a graph of motor speed for a number
of example interfaces--a higher fan RPM is required for nasal
cannula applications, and a lower fan RPM is required for mask
applications. The RPM output of the motor can be kept more stable
by using the control method outlined above. The experimental
results shown in FIG. 12 demonstrate that humidity can be
controlled to an appropriate level for either a mask or a nasal
cannula (which require different motor speeds, with the system
remaining stable and producing an appropriate humidity level at
both high-speed and at low-speed). The x-axis shows time in use (in
seconds). The y-axis shows motor speed (RPM). Line 1201 shows the
motor speed for the system in use with a small nasal cannula. Line
1202 shows the motor speed for the system in use with a large nasal
cannula. Line 1203 shows the motor speed for the system in use with
a tracheostomy interface Line 1204 shows the motor speed for the
system in use with a mask.
[0113] There are other potential ways in which the delayed `self
heating` effect of the blower as it gradually warms up or heats up
during use can be compensated for.
[0114] Firstly, after a period of time of steady work (e.g. one
hour, two hours, etc), the humidity control algorithm can switch
from using the chamber outlet temperature as a variable, to using
the heater plate temperature.
[0115] Secondly, a time component can be implemented in the control
algorithm (e.g. after one hour of work the target chamber outlet
temperature can be increased by e.g. 0.5.degree. C.
[0116] Thirdly, "the heat-up compensation factor" can be used. This
factor can be calculated using: time of work, duty cycle of heater,
and heater plate temperature. If the duty cycle or heater plate
temperature changes over time, under conditions of steady flow rate
and ambient temperature, then this indicates that the air coming
from the blower is becoming hotter with time, and this has to be
compensated for.
Control for Constant Flow Rate
[0117] In the most preferred forms of the invention, the systems 1,
100 or 200 also have a flow control system, which is adapted to
control the flow through the system and keep this aligned as
closely as possible to the desired, user set, level. As outlined
above, the flow and the humidity of the gases in the system are
interlinked. As outlined above, in prior art systems, it is normal
for the fan to be set to a constant speed, and it is assumed that
the flow rate will remain substantially constant if the fan speed
remains constant, or that the pressure at the point of delivery to
the patient is constant. However, the flow can be affected by
changes in the system (which affects the humidity), even if the
power to the fan remains constant, or the fan speed remains
constant. This is especially true if the conduit, or interface, or
both, have a relatively low resistance to flow. The difference or
deviation between the magnitude of the measured or actual flow
against the magnitude of the user-set flow can be characterised as
a `large deviation` or a `small deviation`. In the preferred
embodiment, the difference between the actual flow rate and the
desired (user-set) flow rate determines whether the controller 8
uses fine control or coarse control to match the actual flow rate
to the desired flow rate.
[0118] For example, in the preferred form of system 1, when the
system is first turned on or activated, it `warms up` prior to use.
As it warms up, the flow rate approaches the user set point. A user
will generally not be wearing their interface during the warm up
period, and the interface may not be connected to the delivery
conduit. When a user puts their interface on, or connects the
interface to the conduit, the flow rate will decrease as the
resistance to flow will increase. This can cause a user discomfort.
Other unwanted side effects can also occur--for example a change in
the concentration of oxygen delivered, or a change in the delivered
humidity. The change in flow rate due to the increased resistance
to flow will be large or a large proportion or percentage of the
overall flow rate, and can result in a large deviation of the
measured flow from the user set flow. Another example of a large
flow deviation would be for example if the user interface is
changed or swapped e.g. from a full face mask to a nasal mask or a
nasal cannula. There will be a change in the flow rate that may be
characterised as a large deviation from the user set flow--the
difference between the measured flow and the user set flow will be
large. Large deviations can also occur if e.g. small-bore nasal
cannulas are swapped for large-bore cannulas.
[0119] In contrast, there are changes to the flow rate through the
system that can be characterised as `small deviations`. Some
examples of changes to the system which cause `small deviations`
from the user-set flow rate are as follows: If the geometry of the
delivery conduit changes (e.g. if a user turns over in their sleep
and alters the way the delivery conduit is flexed or bent), then
there will be a small relative or small change or percentage change
in the flow rate, and the deviation of the actual flow rate from
the user set flow rate will also be small. Small deviations from
the user set flow may also occur for example if the position of the
user interface on the user's face or in their nostrils changes.
[0120] For the purposes of this specification, a base flow rate is
set as follows: by the user defining the `user set flow rate`. The
flow rate through the system is measured, continuously or
periodically giving the `actual flow rate` (e.g. via the flow probe
61). As long as the actual flow rate as measured matches the user
set flow rate to within a predefined tolerance--e.g. 3
litres/minute, the controller 8 characterises the flow rate as
within tolerance--that is, there is not a `large deviation` between
the actual measured flow rate and user set flow rate. If the
measured flow rate is different from the user-set flow rate by more
than the predefined tolerance of 3 litres/minute or more from the
set base flow rate, the controller 8 characterises this as a `large
deviation` in a similar manner to that outlined above. In contrast,
if there is a difference between the measured flow rate and the
user-set flow rate that is smaller than 3 litres/minute, this is
characterised as a small deviation. It should also be noted that in
alternative embodiments, the controller could work from a
percentage deviation from the user set flow rate, rather than an
empirical change such as the 3 litres/minute of the preferred
embodiment described above.
[0121] In the preferred embodiment, the control system or control
algorithm loaded into the controller 8 is designed to switch
between coarse control and fine control, depending on whether there
has been a large deviation or a small deviation. If the controller
`sees` a large deviation or a step change in the flow rate, it uses
coarse control parameters to restore the flow rate to the rate set
by a user. If the flow rate is changing slowly, or if there is a
small deviation in the flow rate, the controller 8 uses fine
control parameters to adjust the flow rate.
[0122] To avoid system or measurement deviations associated with
noise or with a patient breathing on the system triggering coarse
control, the actual measured flow used is an average flow
calculated over a period of time greater than a few breath periods,
rather than the instantaneously measured flow.
[0123] A pre-loaded control system or systems (or a control
algorithm or algorithms, or fuzzy logic rule set) which is
incorporated as part of the controller 8, and which acts on the
system 1 (or 100, or 200) to smooth the flow rate with the aim of
delivering constant flow to a user undergoing humidification
therapy is useful as it allows the flow to be set, and known. The
flow is independent of the interface being used, the fit of the
interface on a user, and the depth of the users breathing. This is
particularly useful if a user is undergoing O.sub.2 therapy for
example by using the system 200. If the flow of O.sub.2 provided by
e.g. a central gases supply (provided to the humidifier chamber via
a wall inlet and conduit) is known (measured by the flow probe),
and the flow rate from a separate atmospheric supply is known
(either measured by a separate flow probe, or calculated from the
system dimensions (e.g. the venturi dimensions) and the measured
flow rate, using an algorithm in the controller), then a look-up
table loaded in the controller 208 can calculate the O.sub.2
fraction in the blended humidified air. For example, the difference
in airflow between a cannula interface and a trachea interface is
typically 5 litres/minute or greater for the same user. If the
separate flow rates from atmosphere and the central supply are
known, the O.sub.2 fraction can be set via user controls 11 to
known values for either of these interfaces without the need for an
O.sub.2 sensor. Also, by having a system that has a flow sensor
which feeds back to the controller 208 and which sets the flow
irrespective of the interface or breathing pattern of the patient,
the humidity can be precisely controlled as outlined herein.
Therefore, with a preset flow the breathing assistance system can
deliver precise oxygen fractions and humidity without the need for
an oxygen sensor or humidity sensor. Precise flow control enables
precise delivery of blended oxygen. Precise flow control also
enables precise control of the humidity levels in the gases (for
example blended oxygen) delivered to the patient.
[0124] A schematic diagram showing the operation of a control
system 300 is shown in FIG. 9. In the preferred form, the
controller 8 (or 108 or 208) is loaded with a control system 300.
The controller 8 uses P.I.D. control algorithms from a P.I.D.
filter 313 as the coarse control parameters or large deviation
control parameters. In the filter 313, the `P` or proportional part
is shown as 301, the `I` or integral part is shown as 302, and the
`D` or derivative part is shown as 303. In the control sub-system
or algorithm, the fan unit 13 is shown, with the flow probe 61
shown downstream of the fan unit 13. User input from the controls
11 is shown as arrow 304. A feedback signal 307a is shown from the
output of the control system or sub-system back to the front or
input end, to be fed into the filter 313 along with a signal
indicative of user set flow rate-user input 304 (it should be noted
that when the phrase `user set flow rate` is used in this
specification, it can be taken to mean the user input signal 304).
Arrow 311 shows the input into the fan unit 13, which is the output
or signal from the P.I.D. filter 313 (either large deviation
control filter 313a or small deviation control filter 313b).
[0125] It can be seen from FIG. 9 that the filter 313 is divided
into a `large deviation control filter` (313a) and a `small
deviation control filter` (313b). The controller 8 switches between
the two filters depending on the parameters outlined above.
[0126] It should be noted that the coarse flow control or `large
deviation` control can be achieved by using heater plate
temperature, or tube temperature, or both, as the input. If the
temperature changes above a certain rate of change (a large
deviation), then the controller initiates coarse control. The
controller could also use the power or duty cycle of the heater
plate or heater wire (or both), and the using a look-up table,
formula or fuzzy logic algorithm. (this flow control can be used as
a stand alone or as a back-up control system). It may not be
accurate enough for oxygen therapy but can be potentially
implemented in surgical humidification or high flow therapy
(without O2).
Also data from the oxygen sensor (air enriched with O2) can be used
as an input for fuzzy logic of flow control (change of O2% may
reflect flow change)
[0127] The flow control method and system described above can be
further refined to control the flow rate during the
inspiration-expiration cycle, as described below.
Intra-Breath Control.
[0128] The flow control method described above addresses average
flow--i.e. mean flow over a time period greater than that of a
number of breathing cycles (e.g. three or more
inspiration-expiration cycles). There is a need for the
implementation of a control system for maintaining constant flow
over the course of a breath (inspiration/expiration). A preferred
manner in which this could be implemented is described below.
[0129] Flow through the conduit will vary as a patient inhales and
exhales (i.e. over the course of a single breath or breathing
cycle). The percentage amount by which the flow will vary over the
course of a breath depends on a number of factors--for example the
resistance of the tube/interface combination, the leak or seal
around the cannula in the nares and the size of the breath taken. A
very high resistance conduit and cannula combination is unlikely to
need a control system for maintaining constant flow over the course
of a breath. However, a low resistance interface such as a nasal
cannula for use with the system 1, 100, or 200 is more likely to
need a control system--the variation in the flow can be relatively
large.
[0130] In some circumstances flow variation may actually be
beneficial--it may reduce the work required by a user to breathe,
and may be more comfortable for a user as the pressure at the nose
during expiration is lower than it would otherwise be for a
constant flow device. In other circumstances it may be beneficial
to have a more constant flow through the tube. This will give a
greater pressure during expiration and cause higher PEEP. This is
useful and advantageous for treating some respiratory ailments. For
a relatively low resistance tube (and low back pressure of the
blower) the change in flow between inspiration and expiration can
be relatively large, for example 5 L/min or more. The change will
be greater when the user set flow is relatively low. Controlling
flow during breathing is generally more difficult than controlling
average flow. This is because the time response of the motor used
as part of the blower unit 13 is often comparable to breath rate.
Care needs to be taken to ensure that the breathing system such as
the breathing assistance system 1 will be stable at all operating
conditions, but maintains a sufficiently fast response. This is
done by careful choice of the control parameters. For example if a
P.I.D. system is used the P, I and D gains must be set very
carefully.
[0131] The intra-breath control method is implemented in the
preferred form as follows, with reference to FIG. 10a.
[0132] Firstly, the flow is sampled at a rate that allows intra
breath variations to be picked up. In the preferred embodiment,
this sample rate is in the region of 25 Hz (e.g. 20-30 Hz--that is,
the flow rate is measured by the flow probe 61 (or 161 or 261)
between 20 and 30 times per second). The flow probe 61 used in the
preferred form of breathing assistance system 1 must be able to
respond to changes sufficiently quickly to achieve this response.
As outlined above, P.I.D. control algorithms are pre-loaded for use
in the controller 8. A problem with the `D` or Derivative term 303a
or 303b is that small amounts of measurement or process noise can
cause large amounts of change in the output. In the preferred form
of the present invention, in order to ensure the response is
sufficiently rapid, this filter is not present. Alternatively, as
shown in FIG. 10a, a low pass filter 321 with cut-off frequency
high enough to allow intra-breath flow variation to pass
unattenuated or nearly unattenuated is used. This increases the
response time of the fine control system so that both the average
and the intra breath variation will be compensated for. Care needs
to be taken to ensure that the parameters of the control filter are
chosen to ensure unwanted effects such as overshoot and oscillation
that will cause the user discomfort do not occur over the entire
range of flows used and for all patient interfaces used.
[0133] The system could also be used without the filter 321
present. However, removing this filter may require the use of a
more accurate flow sensor. The gains used will have to be kept
small enough to make sure that the noise does not adversely affect
behaviour--this may result in a performance that is not ideal, e.g.
the flow may not be as constant as one would like.
[0134] As outlined above, the controller 8 uses either fine or
coarse control by constantly receiving input from the flow probe
61, which samples the flow rate between 20 and 30 times per second
in the preferred embodiment. The instantaneous flow is used to
calculate the average flow over a period of time greater than a few
breath cycles using e.g. a low pass filter 320 which is used to
calculate the deviation of the average flow from the user-set or
desired flow. In the preferred embodiment, if the measured average
flow is different by a preset value of e.g. greater than 3
Litres/minute from the user-set or desired flow rate, then the
controller 8 uses coarse control parameters or `large flow
deviations` 313a to adjust the flow rate to the user-set level. If
the average flow rate deviates from the average by a proportion of
15%, or more than 3 litres/minute, then the controller 8 or 108
initiates coarse control. Otherwise, fine control or small flow
deviations 313b are used.
[0135] In order to ensure that stable operation is maintained
during coarse control the average flow obtained using the output of
filter 320 can be fed back into the controller rather than the
instantaneous measured flow shown in FIG. 10a.
[0136] In a variant or second preferred form or embodiment, the
controller 8 compensates for flow variation resulting from the
breathing cycle by passing the signal 307a (the signal indicative
of actual flow rate) in parallel through a low pass filter 308 and
a high pass filter 309, as shown in FIG. 10b. The low pass filter
produces an output signal 307b. The high pass filter 309 produces
an output signal 315 that feeds back to a compensation filter 306.
The output signal 311 from the P.I.D controller and the output
signal 312a from the compensation filter 306 is used to control the
speed of the fan in the fan unit 13. This has the advantage of
allowing the P.I.D. filter 313 for the average to be set
independently of the intra-breath control filter. This makes it
easier to design a stable and robust control system.
[0137] The dual feedback loops shown in FIG. 10b allow separate
P.I.D. gains, so that average and intra breath flow can be
controlled. The decision as to whether to use fine or coarse
control for the adjustment of the mean flow is made by examining
the deviation of the output of the low pass filter, 307b, from the
user set flow as described previously.
[0138] Yet another difficulty which is encountered with prior art
systems, is that the breathing assistance system is a nonlinear
system--the open loop gain to the system varies with the state of
the breathing assistance system. That is, a given change in blower
pressure or motor speed will produce a change in the flow rate that
depends on the current state of the breathing assistance system.
For example if the blower unit 3 is operating at a high flow rate
condition, and the overall flow rate changes by a certain amount
because the user exhales, the change in pressure or motor speed
required to compensate for this change will be different than it
would be if the blower unit 3 was operating at a low flow rate.
This can cause problems with stability, and it is possible for
prior art control systems to become unstable at some flow values or
motor speeds. Also it is possible that the response time may become
too slow to adequately compensate for intra-breath variation. This
can be a particularly problematic in a system where the response
time is similar to that of the disturbance, for example in systems
where rate of flow variation is similar to the time response of the
fan unit 13.
[0139] There are a variety of different controllers that can be
modified to help overcome these effects. One way is to use a
controller with a control filter with parameters that vary as a
function of the state of the system. For example, if a P.I.D.
controller is used the P, I and D parameters may not be constant
but a function of the average (or even instantaneous) flow, or
blower pressure or motor speed or of the user set flow.
FIG. 11 shows a schematic diagram of how this might be achieved.
The control system is the same as that shown in FIG. 10 and as
described above, but with the addition of a feedback signal 316
from the flow generator or fan unit 13 to the compensation filter
306. The input signal to the fan unit 13 in this variant will
therefore be the output signal 311 from the P.I.D. filter 313, and
the signal 312b from the compensation filter 306.
* * * * *