U.S. patent application number 09/918182 was filed with the patent office on 2002-07-11 for aerosol dispensing inhaler training device.
This patent application is currently assigned to 1263152 Ontario Inc.. Invention is credited to Strupat, John P., Verdun, Alex M.W..
Application Number | 20020090601 09/918182 |
Document ID | / |
Family ID | 21778796 |
Filed Date | 2002-07-11 |
United States Patent
Application |
20020090601 |
Kind Code |
A1 |
Strupat, John P. ; et
al. |
July 11, 2002 |
Aerosol dispensing inhaler training device
Abstract
An aerosol dispensing inhaler training device for determining
whether a user is properly operating an aerosol dispensing device.
The training device includes an aerosol dispensing device having a
container with a valve stem extending longitudinally therefrom and
movable between a closed position and an open position. The
container dispenses a portion of the contents within the container
when the valve stem is moved to the open position. The aerosol
dispensing device includes a housing adapted to support the
container reciprocally moveable within the housing along a
longitudinal axis from a first position, the housing comprising a
well adapted to receive the valve stem and an exhaust port
comprising one end in fluid communication with the well and a
second end in fluid communication with the ambient atmosphere,
wherein the portion of the contents within the container is
dispensed from the first end of the exhaust port to the second end
of the exhaust port when the housing moves to an actuation position
where the valve stem is actuated so that a portion of the contents
within the container is dispensed through the second end of the
exhaust port when the valve stem is moved to the open position. An
actuation sensor generates a signal that indicates when the housing
is moved to the actuation position and the valve stem is actuated.
A shake sensor determines whether the contents within the container
have been properly agitated for consumption by a user.
Inventors: |
Strupat, John P.; (London,
CA) ; Verdun, Alex M.W.; (London, CA) |
Correspondence
Address: |
John C. Freeman
BRINKS HOFER GILSON & LIONE
P.O. BOX 10395
CHICAGO
IL
60610
US
|
Assignee: |
1263152 Ontario Inc.
|
Family ID: |
21778796 |
Appl. No.: |
09/918182 |
Filed: |
July 30, 2001 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
09918182 |
Jul 30, 2001 |
|
|
|
09016756 |
Jan 30, 1998 |
|
|
|
Current U.S.
Class: |
434/363 |
Current CPC
Class: |
A61M 2016/0021 20130101;
A61M 15/0005 20140204; A61M 2205/332 20130101; A61M 15/0065
20130101; A61M 2205/52 20130101; A61B 5/0876 20130101; A61M 15/009
20130101 |
Class at
Publication: |
434/363 |
International
Class: |
G09B 003/00 |
Claims
We claim:
1. An aerosol dispenser comprising: a container comprising an
interior; a shake sensor positioned within an interior of said
aerosol dispenser, said shake sensor determining whether the
contents of said interior of said container have been properly
agitated for consumption by a user.
2. The aerosol dispenser comprising: a movable vane attached within
said interior of said aerosol dispenser.
3. The aerosol dispenser of claim 2, comprising a sensor to measure
the amount of acceleration of said movable vane.
4. The aerosol dispenser of claim 2, comprising a mass attached to
said movable vane.
5. The aerosol dispenser of claim 3, comprising a mass attached to
said movable vane.
6. The aerosol dispenser of claim 3, wherein said movable vane
comprises a magnetic element that is sensed by said sensor.
7. The aerosol dispenser of claim 6, wherein said magnetic element
is adjacent to said sensor at a rest position.
8. The aerosol dispenser of claim 6, wherein said magnetic element
is spaced from said sensor at a rest position.
9. The aerosol dispenser of claim 6, said movable vane comprising a
second magnetic element that is sensed by said sensor.
10. The aerosol dispenser of claim 9, wherein said second magnetic
element is adjacent to said sensor at a rest position.
11. The aerosol dispenser of claim 10, wherein said second magnetic
element is spaced from said sensor at said rest position.
12. The aerosol dispenser of claim 9, wherein said magnetic element
is spaced from said sensor at a rest position.
13. The aerosol dispenser of claim 12, wherein said second magnetic
element is spaced from said sensor at said rest position.
14. The aerosol dispenser of claim 1, wherein said shake sensor
comprises a contact member and a contact surface, wherein said
contact member moves in response to movement of said container.
15. The aerosol dispenser of claim 14, wherein said shake sensor
detects the number of times said contact member contacts said
contact surface.
16. The aerosol dispenser of claim 14, wherein said shake sensor
comprises a cylindrical tube wherein said contact surface is
attached to an end of said cylindrical tube.
17. The aerosol dispenser of claim 16, wherein said contact surface
is circular and encloses said end of said cyl indrical tube.
18. The aerosol dispenser of claim 16, wherein said contact member
comprises a spherical ball positioned within said cylindrical
tube.
19. The aerosol dispenser of claim 17, wherein said contact member
comprises a spherical ball positioned within said cylindrical
tube.
20. The aerosol dispenser of claim 1, wherein said shake sensor
comprises a transducer attached to said contact surface.
21. The aerosol dispenser of claim 16, wherein said shake sensor
comprises a transducer attached to said contact surface.
22. A method of determining whether the contents of a container
have been properly mixed for consumption by a user, said method
comprising the steps of: agitating the contents contained within a
container; determining the number of times said contents within
said container are agitated; and comparing the number of times said
contents within said container are agitated with a predetermined
number representative of an adequate number of times said contents
within said container should be agitated for consumption by a
user.
23. The method of claim 22, comprising the step of: generating a
signal when said number of times said contents within said
container are agitated is equal to said predetermined number that
indicates that said contents within said container are properly
mixed for consumption by a user.
24. The method of claim 22, wherein said determining step comprises
counting the number of times a movable vane is accelerated beyond a
predetermined acceleration value, wherein said movable vane is
accelerated in response to said agitating step.
25. The method of claim 22, wherein said determining step comprises
counting the number of times a contact member attached to said
container contacts said contact member, wherein said contact member
moves in response to said agitating step.
26. An aerosol dispenser for dispensing a liquid in aerosol form
comprising: a container having a valve stem extending
longitudinally therefrom and movable between a closed position and
an open position, said container dispensing a portion of the
contents within said container when said valve stem is moved to the
open position; a housing adapted to support said container
reciprocally moveable within said housing along a longitudinal
axis, said housing comprising a well adapted to receive said valve
stem and an exhaust port comprising one end in fluid communication
with said well and a second end in fluid communication with the
ambient atmosphere, wherein said portion of said aerosol is
dispensed from said first end of said exhaust port to said second
end of said exhaust port such that said portion of said contents
within said container is dispensed through said second end of said
exhaust port when said valve stem is moved to the open position;
and a flow measurement device comprising a movable vane attached to
said housing between said first end and said second end of said
exhaust port, wherein said movable vane has a shape that occludes
50% or less of the area of defined by said second opening.
27. The aerosol dispenser of claim 26, comprising a sensor to
measure the amount of movement of said movable vane.
28. The aerosol dispenser of claim 26, wherein said movable vane
pivots from a rest position where said movable vane is positioned
when none of the contents within said container is flowing through
said exhaust port to a second position that is representative of
the flowage of said contents within said container when said
portion of said contents within said container flow through said
exhaust port.
29. The aerosol dispenser of claim 28, comprising a sensor to
measure said second position.
30. The aerosol dispenser of claim 27, wherein said movable vane
comprises a magnetic element that is sensed by said sensor.
31. The aerosol dispenser of claim 29, wherein said movable vane
comprises a magnetic element that is sensed by said sensor.
32. The aerosol dispenser of claim 31, wherein said magnetic
element is adjacent to said sensor at s aid rest position.
33. The aerosol dispenser of claim 31, wherein said magnetic
element is spaced from said sensor at said rest position.
34. The aerosol dispenser of claim 30, said movable vane comprising
a second magnetic element that is sensed by said sensor.
35. The aerosol dispenser of claim 34, wherein said second magnetic
element is adjacent to said sensor at said rest position.
36. The aerosol dispenser of claim 35, wherein said second magnetic
element is spaced from said sensor at said rest position.
37. The aerosol dispenser of claim 34, wherein said magnetic
element is spaced from said sensor at said rest position.
38. The aerosol dispenser of claim 37, wherein said second magnetic
element is spaced from said sensor at said rest position.
39. An aerosol dispensing inhaler training device for determining
whether a user is properly operating an aerosol dispensing device,
said aerosol dispensing inhaler training device comprising: an
aerosol dispensing device comprising: a container having a valve
stem extending longitudinally therefrom and movable between a
closed position and an open position, said container dispensing a
portion of the contents within said container when said valve stem
is moved to the open position; and a housing adapted to support
said container reciprocally moveable within said housing along a
longitudinal axis from a first position, said housing comprising a
well adapted to receive said valve stem and an exhaust port
comprising one end in fluid communication with said well and a
second end in fluid communication with the ambient atmosphere,
wherein said portion of said contents within said container is
dispensed from said first end of said exhaust port to said second
end of said exhaust port when said housing moves to an actuation
position where said valve stem is actuated so that said portion of
said contents within said container is dispensed through said
second end of said exhaust port when said valve stem is moved to
the open position; a flow measurement device comprising a movable
vane with a magnetic element, said movable vane is attached to said
housing and is located within said housing, a flow sensor that
generates a first signal corresponding to the amount of movement of
said movable vane; and an initiation sensor that generates a second
signal that indicates when said housing is moved to said actuation
position and said valve stem is actuated.
40. The aerosol dispensing inhaler training device of claim 39,
comprising a memory that stores an optimum flow rate value for a
person inhaling said portion of said aerosol; a microprocessor that
receives said first signal and calculates the flow rate of said
portion of said contents within said container through said vane;
and a comparator that compares said optimum flow rate value with
said calculated flow rate and generates either an acceptance signal
if the calculated flow rate is greater or equal to said optimum
flow rate value or a failure signal if the calculated flow rate is
less than said optimum flow rate value.
41. The aerosol dispensing inhaler training device of claim 40,
comprising a visual display for displaying said calculated flow
rate.
42. The aerosol dispensing inhaler training device of claim 40,
comprising a speaker for generating a sound that indicates whether
or not said calculated flow rate is acceptable.
43. The aerosol dispensing inhaler training device of claim 39,
wherein said movable vane has a shape that occludes 50% or less of
the area defined by said second end.
44. The aerosol dispensing inhaler training device of claim 39,
wherein said movable vane pivots from a rest position where said
movable vane is positioned when none of the contents within said
container is flowing through said exhaust port to a second position
that is representative of the flowage of said portion of said
contents within said container flows through said exhaust port.
45. An aerosol dispensing inhaler training device for determining
whether a user is properly operating an aerosol dispensing device,
said aerosol dispensing inhaler training device comprising: an
aerosol dispensing device comprising: a container having a valve
stem extending longitudinally therefrom and movable between a
closed position and an open position, said container dispensing a
portion of said contents within said container when said valve stem
is moved to the open position; and a housing adapted to support
said container reciprocally moveable within said housing along a
longitudinal axis from a first position, said housing comprising a
well adapted to receive said valve stem and an exhaust port
comprising one end in fluid communication with said well and a
second end in fluid communication with the ambient atmosphere,
wherein said portion of said contents within said container is
dispensed from said first end of said exhaust port to said second
end of said exhaust port when said housing moves to an actuation
position where said valve stem is actuated so that a portion of
said contents within said container is dispensed through said
second end of said exhaust port when said valve stem is moved to
the open position; a flow measurement device comprising a movable
vane attached to said housing and located within said housing, a
flow sensor that generates a first signal corresponding to the
amount of movement of said movable vane; and a shake sensor
positioned within said interior of said container, said shake
sensor determining whether said contents within said container have
been properly agitated for consumption by a user.
46. The aerosol dispensing inhaler training device of claim 45,
comprising a sensor to measure the amount of acceleration of said
movable vane.
47. The aerosol dispensing inhaler training device of claim 46,
wherein said movable vane comprises a magnetic element that is
sensed by said sensor.
48. The aerosol dispensing inhaler training device of claim 46,
comprising a mass attached to said movable vane.
49. The aerosol dispensing inhaler training device of claim 47,
comprising a mass attached to said movable vane.
50. The aerosol dispensing inhaler training device of claim 45,
wherein said shake sensor comprises a contact member and a contact
surface, wherein said contact member moves in response to movement
of said container.
51. The aerosol dispensing inhaler training device of claim 50,
wherein said shake sensor detects the number of time s said contact
member contacts said contact surface.
52. The aerosol dispensing inhaler training device of claim 45,
comprising a memory that stores an optimum flow rate value for a
person inhaling said portion of said contents within said
container; a microprocessor that receives said first signal and
calculates the flow rate of said portion of said contents within
said container through said vane; and a comparator that compares
said optimum flow rate value with said calculated flow rate and
generates either an acceptance signal if the calculated flow rate
is greater or equal to said optimum flow rate value or a failure
signal if the calculated flow rate is less than said optimum flow
rate value.
53. The aerosol dispensing inhaler training device of claim 52,
comprising a visual display for displaying said calculated flow
rate.
54. The aerosol dispensing inhaler training device of claim 52,
comprising a speaker for generating a sound that indicates whether
or not said calculated flow rate is acceptable.
55. The aerosol dispensing inhaler training device of claim 45,
wherein said movable vane has a shape that occludes 50% or less of
the area of defined by said second end.
56. The aerosol dispensing inhaler training device of claim 45,
wherein said movable vane pivots from a rest position where said
movable vane is positioned when none of the contents within said
container is flowing through said exhaust port to a second position
that is representative of the flowage of said portion of said
contents within said container flows through said exhaust port.
57. The aerosol dispensing inhaler training device of claim 45,
comprising a memory that stores a predetermined number
representative of an adequate number of times said contents within
said container should be agitated for proper mixing for consumption
by a user; a microprocessor that receives signals from said mixing
sensor and calculates the number of times that said contents within
said container are agitated; and a comparator that compares said
predetermined number with said calculated number of times that said
contents within said container are agitated and generates an
acceptance signal if the calculated number of times that said
contents within said container are agitated is equal to said
predetermined number.
58. An aerosol dispensing inhaler training device for determining
whether a user is properly operating an aerosol dispensing device,
said aerosol dispensing inhaler training device comprising: an
aerosol dispensing device comprising: a container having a valve
stem extending longitudinally therefrom and movable between a
closed position and an open position, said container dispensing a
portion of the contents within said container when said valve stem
is moved to the open position; and a housing adapted to support
said container reciprocally moveable within said housing along a
longitudinal axis from a first position, said housing comprising a
well adapted to receive said valve stem and an exhaust port
comprising one end in fluid communication with said well and a
second end in fluid communication with the ambient atmosphere,
wherein said portion of said contents within said container is
dispensed from said first end of said exhaust port to said second
end of said exhaust port when said housing moves to an actuation
position where said valve stem is actuated so that a portion of
said contents within said container is dispensed through said
second end of said exhaust port when said valve stem is moved to
the open position; an actuation sensor that generates a second
signal that indicates when said housing is moved to said actuation
position and said valve stem is actuated; and a shake sensor that
determines whether said contents within said container have been
properly agitated for consumption by a user.
59. The aerosol dispensing inhaler training device of claim 58
comprising: a movable vane attached to said housing.
60. The aerosol dispensing inhaler training device of claim 59,
comprising a sensor to measure the amount of acceleration of said
movable vane.
61. The aerosol dispensing inhaler training device of claim 60,
wherein said movable vane comprises a magnetic element that is
sensed by said sensor.
62. The aerosol dispensing inhaler training device of claim 60,
comprising a mass attached to said movable vane.
63. The aerosol dispensing inhaler training device of claim 61,
comprising a mass attached to said movable vane.
64. The aerosol dispensing inhaler training device of claim 58,
wherein said shake sensor comprises a contact member and a contact
surface, wherein said contact member moves in response to movement
of said container.
65. The aerosol dispensing inhaler training device of claim 64,
wherein said shake sensor detects the number of times said contact
member contacts said contact surface.
66. The aerosol dispensing inhaler training device of claim 58,
comprising a memory that stores a predetermined number
representative of an adequate number of times said contents within
said container should be agitated for proper consumption by a user;
a microprocessor that receives signals from said mixing sensor and
calculates the number of times that said contents with said
container are agitated; and a comparator that compares said
predetermined number with said calculated number of times that said
contents within said container are agitated and generates an
acceptance signal if the calculated number of times that said
contents within said container are agitated is equal to said
predetermined number.
67. An aerosol dispensing inhaler training device for determining
whether a user is properly operating an aerosol dispensing device,
said aerosol dispensing inhaler training device comprising: an
aerosol dispensing device comprising: a container having a valve
stem extending longitudinally therefrom and movable between a
closed position and an open position, said container dispensing a
portion of the contents within said container when said valve stem
is moved to the open position; and a housing adapted to support
said container reciprocally moveable within said housing along a
longitudinal axis from a first position, said housing comprising a
well adapted to receive said valve stem and an exhaust port
comprising one end in fluid communication with said well and a
second end in fluid communication with the ambient atmosphere,
wherein said portion of said contents within said container is
dispensed from said first end of said exhaust port to said second
end of said exhaust port when said housing moves to an actuation
position where said valve stem is actuated so that said portion of
said contents within said container is dispensed through said
second end of said exhaust port when said valve stem is moved to
the open position; a flow measurement device comprising a movable
vane attached to said housing between said first end and said
second end of said exhaust port, a flow sensor that generates a
first signal corresponding to the amount of movement of said
movable vane; an actuation sensor that generates a second signal
that indicates when said housing is moved to said actuation
position and said valve stem is actuated; and a shake sensor
positioned within said interior of said container, said shake
sensor determining whether said contents within said container have
been properly agitated for consumption by a user.
68. The aerosol dispensing inhaler training device of claim 67
comprising: a movable vane attached to said housing.
69. The aerosol dispensing inhaler training device of claim 68,
comprising a sensor to measure the amount of acceleration of said
movable vane.
70. The aerosol dispensing inhaler training device of claim 69,
wherein said movable vane comprises a magnetic element that is
sensed by said sensor.
71. The aerosol dispensing inhaler training device of claim 69,
comprising a mass attached to said movable vane.
72. The aerosol dispensing inhaler training device of claim 70,
comprising a mass attached to said movable vane.
73. The aerosol dispensing inhaler training device of claim 67,
wherein said shake sensor comprises a contact member and a contact
surface, wherein said contact member moves in response to movement
of said container.
74. The aerosol dispensing inhaler training device of claim 73,
wherein said shake sensor detects the number of times said contact
member contacts said contact surface.
75. The aerosol dispensing inhaler training device of claim 67,
comprising a memory that stores an optimum flow rate value for a
person inhaling said portion of said contents within said
container; a microprocessor that receives said first signal and
calculates the flow rate of said portion of said portion of said
contents within said container through said vane; and a comparator
that compares said optimum flow rate value with said calculated
flow rate and generates an acceptance signal if the calculated flow
rate is equal to said optimum flow rate value.
76. The aerosol dispensing inhaler training device of claim 75,
comprising a visual display for displaying said calculated flow
rate.
77. The aerosol dispensing inhaler training device of claim 75,
comprising a speaker for generating a sound that indicates whether
or not said calculated flow rate is acceptable.
78. The aerosol dispensing inhaler training device of claim 75,
wherein said movable vane has a shape that occludes 50% or less of
the area of defined by said second end.
79. The aerosol dispensing inhaler training device of claim 75,
wherein said movable vane pivots from a rest position where said
movable vane is positioned when none of the contents within said
container is flowing through said exhaust port to a second position
that is representative of the flowage of said portion of said
contents within said container flows through said exhaust port.
80. The aerosol dispensing inhaler training device of claim 75,
comprising a memory that stores a predetermined number
representative of an adequate number of times said contents within
said container should be agitated for consumption by a user; a
microprocessor that receives signals from said mixing sensor and
calculates the number of times that said contents within said
container are agitated; and a comparator that compares said
predetermined number with said calculated number of times that said
contents within said container are agitated and generates either an
acceptance signal if the calculated number of times that said
contents within said container are agitated is greater or equal to
said predetermined number or a failure signal if the calculated
number of times that said contents within said container are
agitated is less than said predetermined number.
81. A method of training an individual on how to properly use an
aerosol dispensing device by an individual, said method comprising
the steps of: a) agitating a container; b) determining whether the
contents within said container have been properly agitated during
said agitating step a) for consumption by an individual; and c)
repeating steps a) and b) if it is determined during step b) that
said contents within said container have not been properly agitated
during said step a) for consumption by an individual.
82. The method of claim 81, wherein said determining step b)
comprises determining the number of times said contents within said
container is agitated; and comparing the number of times said
contents within said container are agitated with a predetermined
number representative of an adequate number of times said contents
within said container should be agitated for consumption by a
user.
83. A method of training an individual on how to properly use an
aerosol dispensing device by an individual, said method comprising
the steps of: a) agitating a container; b) dispensing the contents
within said container; c) determining whether said contents within
said container have been properly agitated during said agitating
step a) for consumption by an individual; and d) determining
whether said contents within said container have been properly
dispensed from said container.
84. The method of claim 83, wherein said determining step c)
comprises determining the number of times said contents within said
container are agitated; and comparing the number of times said
contents within said container are agitated with a predetermined
number representative of an adequate number of times said contents
within said container should be mixed for proper mixing for
consumption by a user.
85. The method of claim 84, wherein said determining step c)
comprises determining the flow rate of said contents within said
container dispensed during dispensing step b) and comparing the
flow rate with an optimum flow rate for a person inhaling said
dispensed contents within said container.
86. The method of claim 83, wherein said determining step c)
comprises determining when said contents within said container are
dispensed in step b).
87. The method of claim 85, wherein said determining step c)
further comprises determining when said contents within said
container are dispensed in step b).
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates generally to an aerosol
dispensing inhaler training device, and in particular, to an
aerosol dispensing inhaler training device that can monitor several
parameters, such as the flow rate, shaking of the container and the
activation of the container comprising a solution or suspension
which upon actuation transforms into an aerosol.
[0003] 2. Description of Related Art
[0004] Aerosol administered medication for bronchial therapy in
such conditions as asthma, chronic bronchitis and emphysema is
generally the preferred dosage technique for reasons of efficacy,
reduced side effects and economy. Such particulate drugs are
commonly prescribed using metered dose inhaler (MDI) type devices.
It is well recognized that improper inhalation technique in the use
of MDI devices is a serious barrier to effective therapy.
[0005] Some patients may have difficulty in the use of conventional
MDI devices especially in terms of controlling inhalation, and
proper activation timing of the MDI delivery system. For example,
patients may inhale too fast, or in an erratic manner. Another
common problem is that patients may delay activation of the MDI
device until after inspiration has started, and therefore, the
crucial initial portion of the inspired breath does not contain
medication. After activation, patients may frequently begin their
MDI inspiration breaths at improper levels of lung volume, for
example, their lungs may already be relatively full of air and
therefore a proper large volume of inspired air is impossible.
[0006] Once the proper MDI inspiration breath has been achieved, it
is important for the patient to sustain a brief period of breath
holding so that the medicated mist is properly deposited in the
airways of the patient.
[0007] The desired time interval of breath holding is generally
thought to be about five to ten seconds. However, this desirable
time may be functionally limited, as dictated by individual patient
needs and breath holding capabilities.
[0008] While it is generally felt the timing of MDI activation
should be simultaneous with the beginning of inspiration, there is
some scientific opinion that questions whether said activation
should be a fraction of a second before or after the beginning of
inspiration. However, it is understood that these events are
substantially concurrent.
[0009] It should be apparent from the above, that while the act of
using an MDI device may appear simple, it can be in fact a complex
act, and the proper performance of this technique is crucial to the
optimal delivery of drugs to the bronchial airways. Without proper
MDI inhalation technique, the patient may in fact derive little or
no benefit from this form of drug therapy.
[0010] In this vein, there have been attempts in the past to
measure the magnitude of the flow rate and the timing of the
dispensing of the aerosol along with improving the training of
individuals to use a proper MDI inhalation technique. In the case
of measuring the flow rate, many techniques have been used in the
past ranging from pressure differential techniques (i.e.,
pneumotachs that measure pressure drop across a time meshed screen
with a linear resistance, a bundle of capillary tubes with a linear
resistance, a fixed orifice or a flexible orifice) to mechanical
techniques (i.e., spinning turbines, paddle wheels, hinged flaps
with potentiometers) to ultrasonic techniques (i.e., time of flight
pulses). One disadvantage to the above flow rate techniques, except
the ultrasonics technique, is that the liquid particles present in
a patient's exhaled gas can contaminate the flow rate devices to
the extent that they produce inaccurate readings. The ultrasonics
technique suffers the drawback that it requires relatively
expensive piezoelectric elements and complex signal analysis that
limits widespread application.
[0011] In the case of teaching proper usage of a metered dose
inhaler, past devices and systems have omitted teaching the proper
technique for shaking the aerosol container prior to
inhalation.
SUMMARY OF THE INVENTION
[0012] One aspect of the present invention regards an aerosol
dispensing inhaler training device for determining whether a user
is properly operating an aerosol dispensing device. The training
device includes an aerosol dispensing device having a container
with a valve stem extending longitudinally therefrom and movable
between a closed position and an open position. The container
dispenses a portion of the contents within the container when the
valve stem is moved to the open position. The aerosol dispensing
device includes a housing adapted to support the container
reciprocally moveable within the housing along a longitudinal axis
from a first position, the housing comprising a well adapted to
receive the valve stem and an exhaust port comprising one end in
fluid communication with the well and a second end in fluid
communication with the ambient atmosphere, wherein said portion of
the contents within the container is dispensed from the first end
of the exhaust port to the second end of the exhaust port when the
housing moves to an actuation position where the valve stem is
actuated so that a portion of the contents within the container is
dispensed through the second end of the exhaust port when the valve
stem is moved to the open position. An actuation sensor generates a
signal that indicates when the container is moved to the actuation
position and the valve stem is actuated. A shake sensor determines
whether the contents within the container have been properly shaken
for consumption by a user.
[0013] A second aspect of the present invention regards a method of
training an individual on how to properly use an aerosol dispensing
device. The method includes providing an aerosol dispensing inhaler
training device with a container, agitating the contents of the
container, determining whether the contents of the container have
been properly agitated during the agitating step for consumption by
an individual; and repeating the previous steps if it is determined
that during the agitating step that the contents of the container
have not been properly agitated for consumption by an
individual.
[0014] The present invention provides significant advantages over
other aerosol dispensing inhaler training devices. In particular,
several aspects of the present invention's use of a flow rate
measurement device with reduced risk of being contaminated by a
patient's exhaled gas while at the same time having a simple and
economical structure.
[0015] Another advantage of several aspects of the present
invention is that it regards a device and method for teaching the
proper technique for shaking a container prior to inhalation.
[0016] The present invention, together with further objects and
advantages, will be best understood by reference to the following
detailed description taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 schematically shows a top view of an aerosol
dispensing inhaler training device according to the present
invention;
[0018] FIG. 2 shows a perspective cut away view of an aerosol
dispensing device to be used with the aerosol dispensing training
devices of FIG. 1;
[0019] FIG. 3 shows a cross-sectional view of the aerosol
dispensing device of FIG. 2;
[0020] FIG. 4A shows a side cross-sectional view of the aerosol
dispensing device of FIG. 2;
[0021] FIG. 4B shows an exploded perspective view of the aerosol
dispensing device of FIG. 2;
[0022] FIG. 5 schematically shows a partial cross-sectional view of
a second embodiment of an aerosol dispensing training device
according to the present invention;
[0023] FIG. 6A shows a front view of a first embodiment of a flow
rate measurement device at a resting position according to the
present invention;
[0024] FIG. 6B shows a side view of the flow rate measurement
device of FIG. 6A at a resting position;
[0025] FIG. 6C shows a side view of the flow rate measurement
device of FIG. 6A when a gas is flowing;
[0026] FIG. 6D schematically shows a spirometer that employs the
flow rate measurement device of FIGS. 6A-C;
[0027] FIG. 7A shows a side view of a second embodiment of a flow
rate measurement device at a resting position according to the
present invention;
[0028] FIG. 7B shows a side view of the flow rate measurement
device of FIG. 7A when a gas is flowing;
[0029] FIG. 8A shows a side view of a third embodiment of a flow
rate measurement device at a resting position according to the
present invention;
[0030] FIG. 8B shows a side view of the flow rate measurement
device of FIG. 8A when a gas is flowing in one direction;
[0031] FIG. 8C shows a side view of the flow rate measurement
device of FIG. 8A when a gas is flowing in a direction opposite to
the flow of FIG. 8B;
[0032] FIG. 8D schematically shows a life support ventilator that
employs the flow rate measurement device of FIGS. 8A-C;
[0033] FIG. 9A schematically shows a top view of a fourth
embodiment of a flow rate measurement device to be used with the
aerosol dispensing device of FIGS. 2-4;
[0034] FIG. 9B schematically shows a side view of the flow rate
measurement device of FIG. 9A;
[0035] FIG. 10 shows a top view of an embodiment of a vane to be
used with the flow rate measurement devices of FIGS. 2-4;
[0036] FIG. 11A shows an example of the flow rate or flowage
measured by the flow rate measurement devices of FIGS. 6-9;
[0037] FIG. 11B shows a flow chart for determining the flow rate
using the flow rate measurement devices of FIGS. 6-9;
[0038] FIG. 12 shows a flow chart for determining proper shaking of
the container of FIGS. 2-5;
[0039] FIG. 13 schematically shows an embodiment of a processor to
be used with the aerosol dispensing inhaler training device of
FIGS. 1-5;
[0040] FIG. 14 schematically shows an embodiment of a display to be
used with the aerosol dispensing inhaler training device of FIGS.
1-5;
[0041] FIGS. 16A-G schematically show several display screens shown
during the testing of a user; and
[0042] FIGS. 17A-E schematically show additional display screens
shown during the testing of a user.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
[0043] An aerosol dispensing inhaler training device 100 according
to the present invention is schematically shown in FIGS. 1-17,
wherein like elements are identified by like numerals. As described
below, the aerosol dispensing inhaler training device 100 is
basically made of 5 major components: 1) the aerosol dispensing
device 200, 2) the flow rate measurement device 300, 3) the shaking
sensor 400, 4) the actuation sensor 500, and 5) the monitoring
device 600. Each of these components is discussed below:
[0044] A. Aerosol Dispensing Device
[0045] FIGS. 1-5 show an aerosol dispensing device 200 that
includes a T-shaped housing 202 and a cylindrical container 204
disposed therein. The housing 202 has a longitudinally extending
cylindrical cavity 206 shaped to receive the container. A top
portion of the housing 202 is generally open such that the
container 204 can be inserted into the housing 202 through opening
208 and be installed therein with a bottom end 210 of the container
204 protruding from the housing 202 and exposed to the user for
actuation.
[0046] The term "longitudinal" as used herein is intended to
indicate the direction of the reciprocal movement of the container
204 relative to the housing 202. The terms "top," "bottom,"
"upwardly" and "downwardly" are intended to indicate directions
when viewing the aerosol dispensing device 200 as shown in FIGS.
2-4, but with the understanding that the container 204 is inverted
such that the top surface thereof is located adjacent the bottom of
the housing 202 and vice versa.
[0047] As shown schematically in FIGS. 2 and 4B, a cylindrical
support block 212 having a movable well 214 is formed in a bottom
portion 216 of the housing 202. The movable well 214 is cylindrical
in shape and is inserted an orifice 218 that penetrates the support
block 212 to communicate with a bottom portion of the movable well
214. A spring 219 is also placed in the orifice 218 so that it
surrounds the movable well 214. The spring 219 acts to maintain the
well 214 and the container 204 away from an actuation position to
be described below. A mouthpiece 216, intended for insertion into
the mouth of a patient, forms an exhaust port 220 that has one end
222 in fluid communication with the movable well 214 and a second
end 224 in fluid communication with the ambient atmosphere 226. The
exhaust port 220 has a length of approximately 3.5 cm and an
oval-like cross-section with a maximum width of approximately of
2.2 cm and a maximum height of approximately 1.5 cm. Of course, the
exhaust port 220 may have other shapes, such as cylindrical or
rectangular, without departing from the spirit of the invention.
The mouthpiece 216 extends laterally from the housing 202 so as to
facilitate insertion of the mouthpiece into the mouth of the
patient.
[0048] The cylindrical container 204 has a valve stem 228 extending
longitudinally from the bottom end 230 of the container 204. The
valve stem 228 extends coaxially from the container 204 and is
biased outwardly therefrom by the spring 219 mounted within the
container 204. The container 204 is mounted in the housing 202 by
press fitting the valve stem 228 in the well 214 of the support
block 212.
[0049] In a preferred embodiment, the interior of the container 204
is filled with a pressurized propellant and a placebo solution or
suspension which is dispensed therefrom in specific metered doses
by depressing or moving the valve stem 228 from an extended closed
position to a depressed open position. A single metered dose is
dispensed from the container 204 by each reciprocal, longitudinal
movement of the valve stem 228.
[0050] In operation, the opening of the valve stem 228 is effected
by moving the container 204 reciprocally within the housing 202
along a longitudinal axis, defined by the valve stem 228 and the
reciprocal movement of the container 204, by depressing the exposed
bottom end 210 of the container 204 relative to the housing 202 so
as to move the valve stem 228 and the movable well 214 against the
spring 219 to the open or actuation position as it is supported
within the well by the support block 212. As the well 214 is moved
to an actuation position where the valve stem 228 is moved to the
open position, the container 204 dispenses a portion of the
propellant and the placebo solution or suspension within the
container 204 through the well 214 and orifice 218. A placebo
aerosol is formed within the exhaust port 220. The patient inhales
the placebo aerosol and the air within the exhaust port 220 from
the first end 222 of the exhaust port 220 to the second end 224 of
the exhaust port 220 so that the placebo aerosol is transmitted to
the patient through the mouthpiece 216. A grill 230 is formed in
the bottom rear end 222 of the aerosol dispensing device 200 so as
to allow ambient air to be sucked through the grill and into a
rectangular opening 232 that is formed in the aerosol dispensing
device 200 so as to be directly underneath the vane 302. The grill
230 has three longitudinal slats that are parallel to one another
and separated from one another by approximately 0.2 cm so as to
prevent particles larger than 0.2 cm from entering the exhaust port
220. The rectangular opening 232 has a length of approximately 0.9
cm and a width of approximately 1.3 cm.
[0051] B. Flow Rate Measurement Device
[0052] One of the problems encountered by users of aerosol
dispensing devices in general is that the medication may not be
inhaled properly. Accordingly, the aerosol dispensing inhaler
training device 100 includes a flow rate measurement device 300
that is capable of measuring the flow rate of aerosol through the
aerosol dispensing device 200. As shown in FIG. 2, the flow rate
measurement device 300 preferably is attached to the interior
surface of the exhaust port 220 so as to be positioned between the
well 214 and the rear end 222 of the aerosol dispensing device 200.
Such a position is preferred because it reduces the amount of
aerosol and placebo deposited on the flow rate measurement device
300 and so the flow rate measurement device is able to measure the
inhalation flow without impeding the flow of the aerosol which
leads to more accurate measurements of the flow rate within the
exhaust port 220 when a patient inhales through the mouthpiece
216.
[0053] An embodiment of such a flow rate measurement device 300 is
schematically shown in FIGS. 6A-C. In particular, the flow rate
measurement device 300 has two main components: a movable vane 302
and a sensor 308. The base 309 of the movable vane 302 is secured
by the top and bottom of the interior surface of the housing by
being clamped therebetween (see FIG. 2). Alternatively, the base
309 can be attached to the bottom of the interior surface of the
exhaust port 220 by a well known adhesive. As shown in FIG. 10, the
vane 302 has a thickness of approximately 0.05 cm and a rectangular
upper section 306 that has a length of approximately 1.9 cm and a
width of approximately 1.35 cm. The base 309 has a length of
approximately 0.5 cm and a width of approximately 1.2 cm and is
integrally attached to a rectangular neck 311 that has a length of
approximately 0.65 cm and is integrally attached to the upper
section 306. The vane 302 is made of a spring-like material, such
as stainless steel. Of course, other shapes for the vane 302 and
the upper section 306 are possible without departing from the
spirit of the invention. When the patient is not inhaling through
the exhaust port 220, the vane 302 stands vertically at a resting
position shown in FIG. 6B. When the patient inhales at the
mouthpiece 216, the vane 302 pivots or bends so that the upper
section 306 is deflected towards the mouthpiece 216 in the
direction of the flow of the placebo aerosol and/or inhaled air as
shown in FIG. 6C. Note that the vane 302 preferably bends only when
the patient inhales and not when the placebo aerosol is dispensed.
However, there may be instances where the vane 302 is positioned
within the flow path and/or has its spring constant adjusted so
that it is deflected when the aerosol placebo is also dispensed. In
that case, the vane 302 should occlude approximately 50% of the
area impinged by the flow where the vane 302 is located.
[0054] Two examples of where the vane 302 is positioned within the
flow path is shown in FIGS. 5 and 6D. FIG. 6D shows the vane 302
being used as a flow sensor for a basic pulmonary function
spirometer 313. Spirometry is the measurement of lung function and
is highly dependent on patient effort. To measure the various lung
capacities for volume and flow, the patient exhales at end 315
which causes the exhaled air to deflect the vane 302 and then the
exhaled air leaves through the exit end 317 to the atmosphere. From
the deflection of the vane 302, a microprocessor can calculate and
display such parameters as the peak flow and the FEV1 value. The
test results may be compared against accepted norms for individuals
with similar height, weight, age and sex. Of course, the spirometer
313 may incorporate automated analysis of results, allow entry of
patient data, transmit results electronically, etc.
[0055] The application of the vane 302 would be used for direct
flow measurement and integrate this information for presentation of
volume data. Prior art using other flow sensing methods are more
expensive or delicate than this invention. The invention is robust
and unaffected by contamination with aerosols from the patient's
exhaled gas, by exposure to liquids or cleaning solutions.
[0056] The amount of movement or deflection of the upper section
306 of the vane 302 is a measure of the flow rate or flowage within
the exhaust port 220. A magnetic sensor 308, such as a Hall element
or a magnetoresistive element, is used to measure the movement or
deflection of the upper section 306 of the vane 302 from the rest
position of FIG. 6B to the deflected position of FIG. 6C. In
particular, the sensor 308 measures the deflected position by
detecting the magnetic field strength generated by a magnetic
element, such as a high energy permanent magnet 310 or an
electromagnet, at that position and generating a signal
corresponding to the amount of movement of the movable vane 302.
The magnetic element 310 is attached to the upper section 306 and
preferably is a permanent magnet, such as a type II
Neodymium-Iron-Boron (NeFeB) magnet. The magnetic field produced by
the permanent magnet preferably is unaffected by moisture, liquids
and external magnetic fields and is relatively stable over
temperature and time. One way to protect the magnetic element 310
from the environment is to place a thin plastic, such as polyester,
over the magnetic element 310.
[0057] As shown in the embodiment of FIGS. 6A-D, the sensor 308 is
attached to the top of a support 312 that is itself attached to the
interior surface of the exhaust port 220. The sensor 308 is
positioned above the interior surface of the exhaust port 220 and
is adjacent to magnetic element 310 at the rest position shown in
FIG. 6B. Like the vane 302, a protective layer of thin plastic can
be placed over the sensor 308 to protect it from the
environment.
[0058] A second embodiment of a flow rate measurement device 300 is
shown in FIGS. 7A-B where the flow rate measurement device 300 of
FIGS. 6A-C is altered by adding a second magnetic element 314 that
is spaced from the sensor 308 by approximately 2 mm at the rest
position shown in FIG. 7A. The magnetic element 314 is attached to
the vane 302 via an arm 316.
[0059] As shown in FIGS. 8A-8D, a third embodiment of a flow rate
measurement device 300 is a variation of the flow rate measurement
device 300 of FIGS. 7A-B where the vane 302 is offset from the
support 312 by approximately 1 mm at the rest position. This
results in the magnetic element 310 being spaced from the sensor
308 at the rest position by approximately 1 mm. As shown in FIGS.
8B and 8C, offsetting the vane 302 allows the flow rate measurement
device 300 to measure the flow rate in two directions and to
determine which direction the flow is moving within the exhaust
port 220. This provides the advantage of sensing the flow rate when
the user exhales into the exhaust port 220.
[0060] An example of the use of a bi-directional sensor is shown in
FIG. 8D where the vane 302 is used as a flow sensor in a section of
a life support ventilator circuit 319. The ventilator circuit is
the common descriptor for the tubing, connectors and other
components that confine and direct gas from a ventilator to the
patient, and potentially back again. It is well known that a
ventilator, or other life support or breathing assist device, acts
to provide air or air with additional oxygen, plus humidity, at
breathing rates and volumes sufficient to maintain or support life
or provide assistance in breathing. As shown in FIG. 8D, the vane
302 (approximate length 3 inches, approximate mass 20 grams) is
positioned to measure flow to and from the patient. The signals
from the deflection of the vane 302 may be used to integrate the
flow data to produce a gas volume that can be displayed on a
monitor or sent to other locations. Once patient is through with
the ventilator, the vane 302 can be either entirely disposable or
partially disposable so that a cleaner vane 302 can be used for the
next use.
[0061] A fourth embodiment of a flow rate measurement device 300 is
shown in FIGS. 9A-B. In this preferred embodiment, the vane 302 is
oriented horizontally rather than vertically as in FIGS. 6-8 so
that the free end 318 points toward the mouth piece 216 and along
the flow of the gas. In this embodiment, the magnetic element 310
is attached to the top surface of the vane 302 so as to be
approximately 0.375 cm from the free end 318 and approximately
0.675 cm from either of the side edges 320 of the vane 302. The
sensor 308 is attached to bottom platform 322 so as to face the
bottom of the vane 302. When there is no flow, the bottom surface
of the vane 302 may be either adjacent to the sensor 308 or may be
preloaded so that it is spaced approximately 0.6 cm from the sensor
308.
[0062] Note that several variations of the flow rate measurement
devices 300 of FIGS. 6-9 are possible. For example, the sensor 308
could be attached to the vane 302 and the magnetic element 310
could be mounted on the support 312 or mounted on or in the
interior wall of the exhaust port 220. Another variation is to
preload or stress the vane 302 so that a minimum gas flow is
required to cause deflection of the vane 302.
[0063] The spring-like characteristics of the vanes 302 of FIGS.
6-9 can be altered to meet specific requirements for specific
applications. For example, the aerosol dispensing device can be
enlarged for larger animals, like horses, or reduced in size for
children. For each new application, the spring-like characteristics
of the vane 302 can be optimized for deflection distance, physical
size, resistance to airflow (back pressure) and vane material
selection. In the case of being used for large animals, the vane
302 would be large and thick while the vane 302 for children would
be small and thin.
[0064] An example of the flow rate or flowage measured by the flow
rate measurement devices of FIGS. 6-9 is shown in FIG. 11a. It is
believed that the specific curve in FIG. 11A will shift up or down
during the life of the measurement devices, but the shape (gain) of
the curve will remain the same. In each of the embodiments of FIGS.
6-9, the flow rate or flowage in the exhaust port 220 is determined
by applying the steps shown in the flow chart of FIG. 11b that are
carried out by the microprocessor 602, such as a 4-bit
microcontroller. It is predicted that the ratio of the voltage
signal, Vmax, generated by the sensor 308 at maximum flowage where
the vane 302 is at maximum deflection to the voltage signal Vmin
where the vane 302 is at the rest position is a constant K at all
times. The constant K is preferably measured at the time of
manufacture or calibration of the flow rate measurement device 300
and is stored in a memory of the microprocessor 602. During
operation of the flow rate measurement device 300, the voltage
signal Vrest generated by the vane 302 being at the rest position
when the device 300 is first turned on is fed to and stored in the
microprocessor 602. The microprocessor 602 calculates and stores
the predicted voltage Vmaxdef for maximum deflection of the vane
302 by determining the value of the multiplicative product of K
times the stored value of Vrest. Next, the full range of voltages
that can be measured from no deflection to maximum deflection is
determined by subtracting the voltage Vrest for the rest position
from the calculated voltage Vmaxdef for maximum deflection. This
subtraction also reduces the effect on the voltage of such factors
as manufacturing tolerances and temperature. The full range of
voltages is then divided into seven sub-ranges, where each
sub-range corresponds to one of the seven bar graphs on the flow
rate display 604 of the monitoring device 600. The sub-ranges are
determined by first incrementing the voltage Vrest in sixteen steps
that equal six percent of the full range of voltages. The flow rate
for each increment is then compared with five subranges of flow
rates where the subrange of flow rate that corresponds to the
increment is displayed on display 606 as shown in FIGS. 14-15. An
example of the sub-ranges of the flow rate display 604 is given
FIGS. 11B and 15 and in the table below:
1 Sensor % of Full Range Nearby Flow Voltage Voltage step .times.
6% 0 1.55 0 0 5 1.556 0.9 0 10 1.732 26.4 4 15 1.864 45.6 8 20
1.966 60.4 10 25 2.046 72.0 12 30 2.112 81.6 14 35 2.165 89.3 15 40
2.205 95.1 16 45 2.239 100 16
[0065] The full range of voltages and the sub-ranges are preferably
recalculated with each use. It is understood that the resolution of
the sub-ranges can be increased or decreased by altering the size
of the incremental steps so that a desired resolution can be
achieved. One possible set of sub-ranges is: less than 15 l/min,
15-25 l/min, 25-35 l/min, 35-40 l/min, 40-45 l/min, 45-50 l/min and
greater than 50 l/min where the upper and lower ranges are
unacceptable flow rates.
[0066] C. Shake Sensor
[0067] Besides measuring the flow rate, the moving vane 302 can be
adapted to be a shake sensor 400. This is accomplished by adding a
mass 402 to either of the vanes 302 shown in FIGS. 6-9. As shown in
FIG. 9A, the mass 402 is attached to the upper section 306 by an
adhesive so that it is centered at approximately 0.9 cm from the
free end 318 of the vane 302 and 0.675 cm from either of the side
edges 320. The mass 402 has an annular shape with a thickness of
approximately 0.2 cm, an inner radius of approximately 0.15 cm and
an outer radius of approximately 0.4 cm. The mass 402 preferably is
made of stainless steel and has a mass of approximately 0.41 grams.
The mass 402 performs the function of increasing the amount of
force needed to affect acceleration thereby causing greater
deflection of the vane 302 which can be more easily measured.
[0068] With the mass 402 attached to the vane 302, the voltage
signal generated by the magnetic sensor 308 is processed by the
microprocessor 602 so as to measure differential changes in the
position of the vane 302 when the housing 202 is shaken or
agitated. Measuring the differential changes allows the
microprocessor to measure the acceleration of the housing 202. As
shown in the flow chart of FIG. 12, the measured differential
changes are compared with a predetermined differential change value
that is stored in the microprocessor 602. A typical value of the
stored predetermined differential change value would be 2.5 times
the acceleration of gravity (g=9.8 m/s/s). The stored predetermined
differential change value is representative of an acceptable
acceleration caused by one shake of the container 204. During the
comparison stage, the microprocessor 602 determines whether the
measured differential change is above or below the predetermined
differential change value. If it is above, a counter is incremented
by one to register that a single adequate shake has been performed.
In addition, a beep is generated signaling that the shake was
adequate and indicating that another shake should be performed. The
second shake is performed and the comparison with the predetermined
differential change value is repeated. If the shake is acceptable,
then the counter is incremented another step and a second beep is
generated indicating the second shake was acceptable and that a
third shake should be performed. The above process is continued
until eight consecutive adequate shakes are performed where the
microprocessor 602 signals, via display 604, that the container 204
is properly shaken and the next step of inhaling is to be attempted
by the user. If an inadequate shake is performed at any time before
reaching eight consecutive adequate shakes, then the counter is
reset to zero and the user must start over and attempt to do eight
consecutive adequate shakes in the manner described above.
[0069] Note that during each shake the value of the counter is
compared with a stored number, such as eight, representative of the
minimum number of shakes to properly mix the contents of the
container 204 for consumption by a user.
[0070] As can be seen above, the signal generated by the vane 302
can be used by the microprocessor to measure a number of
quantities, such as the position of the vane, the acceleration of
the vane, the position of the vane in time, etc., and so can be
used to generate other useful quantities, such as peak flow rate,
to monitor the use of the device 200.
[0071] A second embodiment of a shake sensor is shown in FIG. 5. In
particular, a shake sensor 400 is attached to the exterior side of
the housing 202. The shake sensor 400 is in the shape of a
cylindrical tube 404 having a radius of approximately 6 mm and a
height of approximately 10 mm. The top end of the shake sensor 400
is capped off and the bottom end of the shake sensor 400 has a
flexible contact surface 406 attached thereto so as to enclose the
cylindrical tube 404. The contact surface 406 is circular in shape
and is preferably made of plated copper.
[0072] Inside of the cylindrical tube 404 is ambient air. A contact
member, such as the spherical ball 408, is placed in the tube 404
as well. The ball 408 is preferably made of steel, has a radius of
approximately 3 mm, and has a mass of approximately 100 grams.
[0073] The shake sensor 400 operates as follows: The housing 202
and the container 204 are agitated or shaken. Since the tube 404 is
attached to the housing 202, the tube 404 and the ball 408 are also
shaken and moved in response to the shaking of the housing 202 and
the container 204. A measure of the amount of agitation is the
number of times that the ball 408 contacts the contact surface 406.
Each contact between the ball 408 and the contact surface 406 is
detected by a transducer or sensor 410 that is attached to the
exterior side of the contact surface 406.
[0074] The signal generated by the sensor 410 is sent to the
microprocessor 602 where it is processed in the same manner as the
signal generated by the sensor 308 of FIGS. 2-4 and 6-9. To
summarize, the signal is compared with a predetermined value
indicative of an acceptable shake or agitation. The number of
acceptable shakes or agitations is counted and compared with the
previously described stored number representative of the minimum
number of shakes or agitations to properly agitate and mix the
contents of the container 204 for consumption by a user. If the
number of measured shakes or agitations is below the stored number,
then a signal or beep is generated by the microprocessor 602 that
another shake or agitation is required. This process is continued
until the stored number is reached where the microprocessor 602
signals that the container 204 is properly shaken or agitated and
the next step of inhaling is to be attempted by the user. If an
inadequate shake is performed at any time before reaching eight
consecutive adequate shakes or agitations, the user must start over
and attempt to do eight consecutive adequate shakes or agitations
in the manner described above.
[0075] D. Actuation Sensor
[0076] As previously described, the flow rate measurement devices
300 and the shake sensors 400 are used to measure whether the
magnitude of the flow rate within the exhaust port 220 and the
agitation of the container 204 are adequate for using an aerosol
dispensing device. Another important function of the aerosol
dispensing inhaler training device 100 is to test the timing of the
dispensing process, such as the shaking of the container 204 and
the inhalation of the aerosol. To this end, an initiation or
activation sensor 500 is used to detect when a portion of the
propellant and the placebo within the container 204 is dispensed
into the exhaust port 220 for inhalation.
[0077] The actuation sensor 500 is attached to the bottom of the
housing 202 so as to be located within the housing 202 and directly
below either the well 214 (FIGS. 2-4) or the top surface of the
container 204 (FIG. 5) The actuation sensor 500 is a conventional
contact sensor, such as a membrane switch. The sensor 500 can be
protected from the environment by placing a thin plastic, such as
polyester, over the sensor 500.
[0078] When the container 204 is not moved, the top surface of the
container 204 is spaced above the sensor 500 and the bottom of the
housing 202. When the bottom end of the container 204 is depressed
it moves the valve system 228 to the open position that results in
the dispensing of a portion of the placebo into the exhaust port
220. When the valve is first opened, the top surface of the
container 204 (FIG. 5) or the bottom of the movable well 214 (FIGS.
2-4) first makes contact with the sensor 500. This results in the
generation of a signal that is representative of the time when the
housing 202 or the movable well 214 is moved to an actuation
position where the valve stem is first opened and actuated so that
the placebo is dispensed in an aerosol form. This signal is sent to
the microprocessor 602 which then determines whether or not the
timing of the operation of the aerosol dispensing device is proper.
An explanation of the processing of the signal is discussed in the
section below.
[0079] E. Monitoring Device and Training Procedure
[0080] As described above, the three signals from the flow rate
measurement devices 300 of FIGS. 6-9, the shake sensors 400 of
FIGS. 2-5 and the actuation sensor 500 are sent to the
microprocessor 602 residing in the monitoring device 600 as shown
in FIG. 12 (in the case of the shake sensor and the flow rate
measurement devices being incorporated in the same vane 302, the
shake sensor box can be eliminated). The monitoring device 600
monitors itself and processes the signals so that a user of the
aerosol dispensing device 200 can learn how to properly use the
device 200 and dispensing devices like it. In particular, once the
monitoring device 600 is switched on, it runs a testing program
that goes step-by-step through the process of using the device 200
while using the signals from the sensors to determine if a step has
been successfully completed. The program monitors the completion or
failure of a step to determine whether the testing should proceed
or should be repeated. The program also informs the microprocessor
which sensors or measurements are being measured.
[0081] The monitoring device 600 is preferably powered by two AA
alkaline batteries so as to be portable. Of course it is possible
to use other power sources without departing from the spirit of the
invention. Once the monitoring device 600 is turned on by pushing
the ON-OFF switch 604, the liquid crystal display (LCD) 606 is lit
up so as to show several pictures as shown in FIGS. 1 and 14. Upon
being turned on, the microprocessor 602 monitors the batteries and
displays the remaining power in the batteries via the display of a
battery A. As the batteries become weaker, the interior 608 of the
displayed battery A will become lower and lower so as to indicate
that new batteries will be needed. Besides monitoring the
batteries, the microprocessor 602 checks if the other sensors are
working properly. If so, a check mark B is displayed (see screen of
FIG. 16A), and if not, the check mark B and a slash C are displayed
simultaneously (see screen of FIG. 16B).
[0082] Assuming that the monitoring device 600 is in proper running
order and check mark B is displayed, the display 606 will flash the
arrow D near the picture of the dispensing device E (see FIG. 16C).
The flashing arrow D alerts the user to attempt to adequately shake
the container 204 eight consecutive times. A beep will be emitted
by a speaker 608 after every successful shake. No beep will be
generated if the shake is unsuccessful. The lack of a beep also
indicates that the user must start from the beginning and attempt
to achieve the eight consecutive adequate shakes.
[0083] When eight consecutive adequate shakes are achieved, the
display 606 changes. First, it shows a clear screen with a check
mark B (FIG. 17E) indicating the stage has been successfully
completed and then it changes to a screen showing a trachea F
connected to a pair of lungs G (see FIG. 16D). Flashing dots are
shown in the trachea F. A vertical bar graph H and up and down
arrows I and J are also displayed. This signals the user to place
his or her mouth over the mouthpiece 216 and practice inhaling. By
inhaling, the vane 302 will be moved. As described previously, the
signal generated by the sensor 308 is representative of the flow
rate. The microprocessor 602 compares the measured inhalation flow
rate with two stored values representing the high end and low end
of acceptable inhalation flow rates. If the measured flow rate is
below the stored low end value, then the up arrow I will flash and
a high frequency of beeps will be generated to alert the user to
increase the flow rate. If the measured flow rate is above the
stored high end value, then the down arrow J flashes and a low
frequency of beeps is heard to warn the user to decrease the flow
rate.
[0084] Once an acceptable inhalation flow rate is achieved, a beep
will occur and a new screen showing a check mark B (FIG. 17E) will
be shown on the display 606. Next, a new screen is shown that
alerts the user that the inhalation of the placebo aerosol will be
tested next As shown in FIG. 16E, a flashing finger K is displayed
near the dispensing device E. The flashing finger K is a cue for
the user to depress the container 204 while maintaining the
inhalation performed during the step represented by the screen of
FIG. 16D. Upon depression of the container 204, the placebo is
dispensed into the exhaust port 220. The container 204 (FIG. 5) or
the bottom of the movable well 214 (FIGS. 2-4) contacts the
actuation sensor 500 which results in a signal being sent to the
microprocessor 602 and the call up of the screen of FIG. 16F onto
the display 606. If the user does not continue inhaling when
activating the container 204, then the screen of FIG. 17D will show
up on the display 606. Note that the screen of FIG. 16F will also
be called up if the container 204 is not pressed within two seconds
of the call up of the screen of FIG. 16E. Note that the screen of
FIG. 16F will include an "X" that signifies a failed attempt.
[0085] When the screen 16F is called up, the patient should still
be performing the inhalation begun with the screen of FIG. 16D. The
microprocessor 602 monitors the flow rate signals from the vane 302
and measures the flow rate from those signals. If the measured flow
rate is maintained for two seconds within the range represented by
the middle five green bars of the bar graph H (see FIG. 15), then a
check mark is displayed (FIG. 17E). Next, another new screen (see
FIG. 16G) is displayed where the lungs G and trachea F flash for
five seconds to remind the user to hold his or her breath for the
same five seconds. If the measured flow rate is not maintained for
the first second then the user is given an additional second to
achieve an acceptable flow rate. If an unacceptable flow rate is
not achieved during the two second period, then a failure signal is
shown and heard and the user is sent back to the shake step. If an
acceptable flow rate is achieve in the second one second interval,
a signal is displayed and a beep sounds indicating the attempt was
unsuccessful and that the user should repeat the attempt of
inhaling properly for two seconds.
[0086] The monitoring device 600 has several other features. For
example, if the batteries need replacing, then the screen of FIG.
17A is shown on the display 606.
[0087] It is possible to review a user's test results at different
stages of the testing process. This is done by pressing the memory
button 608. Pressing the button 608 once results in a display of
the number of tests attempted and the percentage that were
successful. Two presses causes a display like FIG. 16D with the
percentage of times that the inhaling at that stage was successful.
Three presses results in a display like FIG. 17C where the
percentage displayed is the percentage of times the container 204
was successfully actuated. A fourth press causes a display like
FIG. 17D where the percentage displayed is the percentage of tests
that the user inhaled the placebo aerosol at the proper flow rate
for two seconds. A fifth press returns the screen to that of FIG.
16C.
[0088] Although the present invention has been described with
reference to preferred embodiments, those skilled in the art will
recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention. For example,
the present invention can be used to diagnose or monitor a
patient's pulmonary condition. In addition, the present invention
is equally applicable to triggering the activation of various
aerosol delivery devices, such as metered dose inhalers or
nebulizers and can be used to train patients to inhale other
products properly, such as dry powders. It is understood that
depending on the type or delivery device or product inhaled, that
the microprocessor 602 will need to be reprogrammed to test for
parameters that will indicate proper usage of the device and/or
proper inhalation of the product. It is contemplated, though, that
the testing and monitoring for the new device or inhalation product
will be similar to that described above. With the above comments in
mind, it is intended that the foregoing detailed description be
regarded as illustrative rather than limiting and that it is the
appended claims, including all equivalents thereof, which are
intended to define the scope of the invention.
* * * * *