U.S. patent application number 12/844980 was filed with the patent office on 2012-02-02 for personal spirometer.
This patent application is currently assigned to PMD HEALTHCARE. Invention is credited to Jay Boyce, Antonio Boyer, Wayne Meng.
Application Number | 20120029376 12/844980 |
Document ID | / |
Family ID | 45527448 |
Filed Date | 2012-02-02 |
United States Patent
Application |
20120029376 |
Kind Code |
A1 |
Meng; Wayne ; et
al. |
February 2, 2012 |
Personal Spirometer
Abstract
A portable hand-held spirometer is disclosed for use in taking
respiratory tests and storing and displaying test results. The
configuration of the spirometer includes handgrips that are
positioned to ensure that the user is properly positioned to
provide maximum breathing required for valid test results to be
obtained. The spirometer also includes a progressively illuminated
indicator that can be viewed by the user during a test to provide
an indication in real-time to the user of the expected/desired
duration of the exhalation or inhalation test. The indicator is
completely illuminated only when the measured accumulated volume of
air passing through the spirometer equals a predicted volume
determined based on the age, gender, height, weight and ethnicity
of the user stored in the spirometer. The structures and
arrangement of a turbine assembly and sensors is also disclosed.
Further, a method of receiving, storing and displaying information
on the spirometer via a color touch screen display is also
disclosed.
Inventors: |
Meng; Wayne; (Fogelsville,
PA) ; Boyce; Jay; (Colmar, PA) ; Boyer;
Antonio; (Macungie, PA) |
Assignee: |
PMD HEALTHCARE
Allentown
PA
|
Family ID: |
45527448 |
Appl. No.: |
12/844980 |
Filed: |
July 28, 2010 |
Current U.S.
Class: |
600/538 |
Current CPC
Class: |
A61B 5/0871 20130101;
A61B 5/682 20130101; A61B 5/7475 20130101; A61B 5/7435 20130101;
A61B 5/09 20130101; A61B 5/7405 20130101; A61B 5/091 20130101; A61B
5/087 20130101; A61B 5/7278 20130101 |
Class at
Publication: |
600/538 |
International
Class: |
A61B 5/087 20060101
A61B005/087 |
Claims
1. A portable, hand-held personal spirometer, comprising: a
casework housing having front and rear panels, proximal and distal
ends, and opposite side edges; an opposed pair of handgrips formed
by said housing at said opposite side edges; a pair of
finger-receiving throughholes extending through said housing
adjacent each of said handgrips permitting each of said handgrips
to be gripped by a hand of a user such that the hand of the user is
able to fully encircle, extend around, and gird said handgrip; an
air flow tube mounted to said housing and extending underneath said
front panel across said housing in a direction from said proximal
end to said distal end, said air flow tube being located centrally
between said opposed pair of handgrips and being spaced from each
of said handgrips; and a mouthpiece connected to said air flow tube
and extending from said proximal end of said housing.
2. A portable, hand-held spirometer according to claim 1, wherein
each of said air flow tube and said handgrips is elongate and has a
central longitudinally-extending axis, and wherein said central
longitudinally-extending axis of said air flow tube is
substantially coplanar with said central longitudinally-extending
axes of said handgrips.
3. A portable, hand-held spirometer according to claim 2, wherein
said central longitudinally-extending axis of said air flow tube
and said central longitudinally-extending axes of said handgrips
are substantially parallel.
4. A portable, hand-held spirometer according to claim 3, wherein
each of said handgrips includes an outer covering of an
elastically-deformable, squeezable material.
5. A portable, hand-held spirometer according to claim 1, further
comprising an electronic display screen mounted on said front panel
above said air flow tube and between said pair of finger-receiving
throughholes.
6. A portable, hand-held spirometer according to claim 5, wherein
said display screen is a color touch screen LCD display.
7. A portable, hand-held spirometer according to claim 1, further
comprising an accumulated volume indicator on said front panel of
said housing in a position viewable by the user when taking a
respiratory test, said indicator progressively becoming illuminated
along its length during a respiratory test based on an amount of
accumulated volume of air passing through said air flow tube
measured in real-time by the spirometer such that said indicator
becomes fully illuminated when the accumulated volume of air
measured in real-time by the spirometer equals a Predicted Forced
Vital Capacity (PFVC) or a Predicted Inspiratory Vital Capacity
(PIVC) of the user.
8. A portable, hand-held spirometer according to claim 7, further
comprising a microprocessor that is mounted within said housing,
receives information concerning the flow of air through said air
flow tube during a respiratory test, determines values for said
PFVC or PIVC based on information of the user's age, gender,
height, weight and ethnicity, and controls illumination of said
indicator based on a calculated percentage of said PFVC or PIVC
formed by the accumulated volume of air measured in real-time by
the spirometer during a respiratory test.
9. A portable, hand-held spirometer according to claim 7, further
comprising a speaker that provides an audible indication to the
user during a respiratory test concerning the amount of accumulated
volume of air passing through said air flow tube measured in
real-time by the spirometer
10. A portable, hand-held spirometer according to claim 1, further
comprising a turbine assembly within said air flow tube, said
turbine assembly including a vane mounted for spinning rotation in
said air flow tube, said vane being caused to rotate by air flowing
through said air flow tube and a speed of rotation of said vane
corresponding to a speed of air flowing through said air flow tube
at any instance in time.
11. A portable, hand-held spirometer according to claim 10, further
comprising a pair of sensors arranged on opposite sides of said air
flow tube adjacent said vane, one of said pair of sensors being a
transmitter for directing a beam of electromagnetic radiation
transversely across and through said air flow tube such that the
beam is interruptible by rotation of said vane, and the other of
said sensors being a receiver for detecting whether or not the beam
passes by said vane at any point in time, said receiver generating
and outputting an electronic digital signal corresponding to when
the beam was received and when the beam was interrupted throughout
a duration of a respiratory test.
12. A portable, hand-held spirometer according to claim 11, wherein
said transmitter is a diode, said receiver is a phototransistor,
and said electromagnetic radiation is infrared radiation.
13. A portable, hand-held spirometer according to claim 12, further
comprising a shroud extending in front of each of said sensors and
having a narrow opening limiting the beam of infrared radiation to
a narrow spherical cone with a predetermined effective angle and
limiting the receipt of reflections by the receiver.
14. A personal spirometer, comprising: a portable, hand-held
casework housing having front and rear panels, proximal and distal
ends, and opposite side edges, said housing forming an opposed pair
of handgrips at said opposite side edges and a pair of
finger-receiving throughholes extending through said housing
adjacent each of said handgrips permitting each of said handgrips
to be gripped by a hand of a user such that the hand of the user is
able to fully encircle, extend around, and gird said handgrip; an
air flow tube mounted to said housing and extending underneath said
front panel across said housing in a direction from said proximal
end to said distal end and being located centrally between said
opposed pair of handgrips; a mouthpiece connected to said air flow
tube and extending from said proximal end of said housing; an
electronic touch screen display mounted on said front panel above
said air flow tube and between said pair of finger-receiving
throughholes; an accumulated volume indicator on said front panel
in a position viewable by the user when taking a respiratory test,
said indicator progressively becoming illuminated during a
respiratory test based on an amount of accumulated volume of air
passing through said air flow tube measured in real-time by the
spirometer such that said indicator becomes fully illuminated when
the accumulated volume of air measured in real-time by the
spirometer equals a Predicted Forced Vital Capacity (PFVC) or a
Predicted Inspiratory Vital Capacity (PIVC) of the user; and a
microprocessor mounted within said housing, said microprocessor
automatically determining values for said PFVC or PIVC based on
information of the user's age, gender, height, weight and ethnicity
and automatically controlling illumination of said indicator based
on a calculated percentage of said PFVC or PIVC formed by the
accumulated volume of air measured in real-time by the spirometer
during a respiratory test.
15. A spirometer according to claim 14, wherein each of said air
flow tube and said handgrips is elongate and has a central
longitudinally-extending axis, wherein said central
longitudinally-extending axis of said air flow tube is
substantially coplanar with said central longitudinally-extending
axes of said handgrips, wherein said central
longitudinally-extending axis of said air flow tube and said
central longitudinally-extending axes of said handgrips are
substantially parallel, and wherein each of said handgrips includes
an outer covering of an elastically deformable squeezable
material.
16. A spirometer according to claim 15, further comprising: a
turbine assembly including a vane mounted for spinning rotation in
said air flow tube, said vane being caused to rotate by air flowing
through said air flow tube and a speed of rotation of said vane
corresponding to a speed of air flowing through said air flow tube
at any instance in time; and a pair of sensors arranged on opposite
sides of said air flow tube adjacent said vane, one of said pair of
sensors being a transmitter for directing a beam of electromagnetic
radiation transversely across and through said air flow tube such
that the beam is interruptible by rotation of said vane, and the
other of said sensors being a receiver for detecting whether or not
the beam passes by said vane at any point in time; an electronic
digital signal corresponding to when the beam was received by said
receiver and when the beam was interrupted throughout duration of a
respiratory test being generated by said receiver and is
communicated to said microprocessor for calculating the accumulated
volume of air flow.
17. A spirometer according to claim 16, further comprising a shroud
extending in front of each of said sensors and having a narrow
opening limiting the beam to a narrow spherical cone with a
predetermined effective angle and restricting receipt of the beam
to an angle that reduces receipt of reflections.
18. A method of receiving, processing and displaying information on
a portable, hand-held personal spirometer, comprising the steps of:
storing information concerning the age, gender, height, weight and
ethnicity of a user on a microcontroller unit contained within the
spirometer with data entry via a color touch-screen display of the
spirometer; scheduling and storing alarms in the microcontroller
unit with data entry via the color touch-screen display with
respect to date and time of day when respiratory tests should be
taken by the user and when medications should be taken by the user;
automatically issuing alarms via the microcontroller unit from the
spirometer to remind the user of scheduled respiratory tests and
times to take medication; measuring air flow through an air flow
tube of the spirometer in real-time during a respiratory test and
providing via sensors an electronic digital signal to the
microcontroller unit with respect to measured air flow; calculating
and storing values within the microcontroller unit of different
test parameters provided by the respiratory test results; and
displaying information concerning test results and test result
trends in numerical data form and graphical form to the user via
the color touch screen display, the particular test parameters,
test results, test result trends and display format being
selectable by the user via use of the touch screen display.
19. A method according to claim 18, further comprising the step of
displaying a home page display on the touch screen display having a
plurality of icons that, when activated by being touched by the
user, activate a function of the spirometer, the functions
including uploading data to a host computer, running a respiratory
test, viewing test result trends, managing medications, and setting
alarms.
20. A method according to claim 18, wherein the microcontroller
unit determines predicted values of the test parameters based on
the stored information of the user's age, gender, height, weight
and ethnicity, determines and displays a percentage of the
predicted value for each test parameter measured, and determines
and displays a severity of each test parameter measured.
21. A method according to claim 20, wherein, when test results are
displayed on the touch screen display, the test results are
color-coded such that any test result determined to be of high
severity by the microcontroller unit is automatically displayed in
red or in flashing red to alert the user of the high severity of
the test result.
22. A method according to claim 18, further comprising the step of
managing medicines via the touch-screen display, including
displaying a scrollable list of prescribed medicines along with
dosage and start and end dates stored by the microcontroller unit,
selecting a particular medicine on the display screen so that the
microcontroller unit automatically displays scheduled times and
dates to take the medicine, entering a new medication to the list
of prescribed medicines, checking the medication schedule, viewing
the medication history for medications already taken, and logging
an entry with respect to providing an acknowledgement that a
medication was taken.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to a spirometer or like
respiratory testing device for use in testing lung and airway
capacity or function of a patient and/or for measuring the amount
or volume and/or speed or flow of air that can be inhaled and/or
exhaled by the patient, and more particularly, the present
invention relates to a portable, lightweight, hand-held spirometer
particularly suitable for home and personal use, although equally
capable of being used in hospitals, doctor's offices, and like
institutions. The present invention is also directed to a system,
software, and method for obtaining, storing and displaying the
results of spirometry tests.
[0002] In general, a spirometry test measures the air entering and
leaving the lungs and airways and is often used as a preliminary
test for accessing the health condition of a patient's lungs and
airways as well as a means for periodically tracking the progress
of disease treatment and effect of medication. The spirometry test
is typically performed using a device known as a spirometer, and
the data provided by the test is often provided graphically in the
form of a "volume-time curve" in which volume in liters is shown
along the Y-axis and time in seconds is shown along the X-axis
and/or in the form of a "flow-volume loop" in which the rate of
airflow is shown on the Y-axis and the total volume inspired or
expired is shown on the X-axis.
[0003] By way of example, a few common parameters that may be
measured during respiratory testing include: Forced Vital Capacity
(FVC) which is the total volume of air that can be forcibly blown
out after full inspiration; Forced Expiratory Volume (FEV) at timed
intervals (for instance, at 1.0 second (FEV1)); Forced Expiratory
Flow (FEF) which is the average flow (speed) of air coming out of
the lungs and airways during a specified period of the expiration;
and Peak Expiratory Flow (PEF) which is the maximum flow (speed) of
air during maximum expiration initiated after full inspiration.
These parameters are often provided in raw data form (i.e., in
liters, liters/second, liters/minute, etc.) and as percent
predicted (i.e., a percent of a predicted value for a patient of
similar age, height, weight, gender and ethnicity).
[0004] Each test is typically repeated three times to ensure
reproducibility. The obtained results of the tests are highly
dependent on patient cooperation and effort. For meaningful and
valid test results to be obtained, the patient must provide
vigorous and maximum respiratory effort for full expiration and/or
inhalation. Typically, if the test is given during an office visit
or at a hospital or the like, the patient will be coached and
motivated by the attending nurse, physician or technician to keep
exhaling as hard as possible for a predetermined period of time
(i.e. "keep going, don't stop"). However, no such assistance is
typically provided during home use of a spirometer; thus, the
obtained home test results may not necessarily be valid if maximum
effort is not provided throughout the duration of full expiration
or inhalation.
[0005] Some basic examples of spirometers and like instruments are
disclosed by U.S. Patent Application Publication Nos. 2006/0282002
A1 of Wang et al., 2007/0239058 A1 of Krasilchikov et al.,
2009/0270751 A1 of Peng et al., 2006/0100537 A1 of Williams et al.
and 2005/0256421 A1 of Bryant et al. and by U.S. Pat. Nos.
5,518,002 issued to Wolf et al., 5,816,246 issued to Mirza,
6,447,459 B1 issued to Larom, 7,282,032 B2 issued to Miller,
4,122,842 issued to Pikul, U.S. Pat. No. D.339,635 issued to
Waterson et al., 7,390,305 B2 issued to Nuttall, 6,019,731 and
6,042,551 issued to Harbrecht et al., 4,736,750 issued to
Valdespino et al., 4,991,591 issued to Jones et al., 5,715,831 and
6,113,549 issued to Johnson, 6,176,833 B1 issued to Thomson,
4,635,647 issued to Choksi, 4,495,944 issued to Brisson et al.,
6,238,353 issued to Weinstein et al., 6,656,129 B2 issued to Niles
et al. and 7,625,345 B2 issued to Quinn.
[0006] While known spirometers and like respiratory testing
instruments may function in an acceptable manner, there continues
to be a need for a portable personal spirometer having improved
features with respect to ease of use and ability to readily and
reproducibly obtain meaningful, valid test results so that progress
of treatment and effect of medication over an extended period of
time can be tracked in a reliable manner. For instance, a
spirometer that is lightweight and compact and enables unsupervised
use of the spirometer at home or the like yet still generates
meaningful, reliable and valid test results that can be saved and
studied at a later time by a patient, nurse, doctor or physician is
desired.
SUMMARY OF THE INVENTION
[0007] According to one aspect of the present invention, a
portable, hand-held spirometer is provided having a casework
housing with front and rear panels, proximal and distal ends, and
opposite side edges. An opposed pair of handgrips are formed by the
housing at the opposite side edges, and a pair of finger-receiving
throughholes extend through the housing adjacent each of the
handgrips. This configuration permits each of the handgrips to be
gripped by a hand of a user such that the hand of the user is able
to fully encircle, extend around, and gird the handgrip enabling
tight gripping and squeezing of the handgrips. The spirometer also
includes an air flow tube extending underneath the front panel
across the housing from the proximal end to the distal end and a
mouthpiece connected to the air flow tube. The air flow tube is
located centrally between the opposed pair of handgrips and is
spaced from each of the handgrips.
[0008] According to contemplated embodiments of the spirometer,
each of the air flow tube and handgrips is elongate and has a
central longitudinally-extending axis, and the central
longitudinally-extending axis of the air flow tube is substantially
coplanar with the central longitudinally-extending axes of the
handgrips. In addition, the central longitudinally-extending axis
of the air flow tube and the central longitudinally-extending axes
of the handgrips can be substantially parallel. Further, each of
the handgrips can include an outer covering of an
elastically-deformable, squeezable material.
[0009] The spirometer can also include an electronic display screen
mounted on the front panel above the air flow tube and between the
pair of finger-receiving throughholes. This display screen can be a
color touch screen LCD display. Thus, data entry and user control
of the spirometer is provided by touching icons, test listings, or
other selections displayed on the screen. In addition, a color
display enables test results and graphs to be color-coded thereby
permitting results considered of "high" severity to be clearly
highlighted on the display.
[0010] The spirometer can further include an accumulated volume
indicator on the front panel of the housing in a position
conveniently viewable by the user when taking a respiratory test.
The indicator progressively becomes illuminated along its length
during a respiratory test based on an amount of accumulated volume
of air passing through the air flow tube measured in real-time by
the spirometer. The indicator becomes fully illuminated when the
accumulated volume of air measured in real-time by the spirometer
equals a Predicted Forced Vital Capacity (PFVC) or a Predicted
Inspiratory Vital Capacity (PIVC) specifically determined for the
particular user. A microprocessor can be mounted within the housing
to receive information concerning the flow of air through the air
flow tube during a respiratory test and can determine values for
PFVC or PIVC based on stored information of the user's age, gender,
height, weight and ethnicity. In addition, the microprocessor
controls illumination of the indicator based on a calculated
percentage of the PFVC or PIVC reached by the accumulated volume of
air measured in real-time by the spirometer during a respiratory
test.
[0011] The spirometer can include a turbine assembly within the air
flow tube. The turbine assembly includes a vane mounted for
spinning rotation in the air flow tube. The vane is caused to
rotate by air flow through the air flow tube, and a speed of
rotation of the vane corresponds to a speed of air flow through the
air flow tube at any instance in time. A pair of sensors can be
arranged on opposite sides of the air flow tube adjacent the vane.
One of the pair of sensors is a transmitter for directing a beam of
electromagnetic radiation transversely across and through the air
flow tube such that the beam is interruptible by rotation of the
vane. The opposed sensor is a receiver for detecting whether or not
the beam passes by the vane or is interrupted by the spinning vane
at any point in time. The receiver generates and outputs an
electronic digital signal to the microprocessor, and the signal
corresponds to when the beam was received and when the beam was
interrupted throughout duration of a respiratory test. As an
example, the transmitter can be a diode, the receiver can be a
phototransistor, and the electromagnetic radiation can be infrared
radiation. A shroud can be extended in front of each of the sensors
(receiver and transmitter). The shrouds can include narrow openings
for the purpose of limiting the beam of infrared radiation being
transmitted to a narrow spherical cone with a predetermined
effective angle and for the purpose of limiting the infrared
radiation being received to prevent any effects from undesired
reflections within the air flow tube.
[0012] According to another aspect of the present invention, a
method of receiving, processing and displaying information on a
portable, hand-held spirometer is provided. Information concerning
the age, gender, height, weight and ethnicity of a user is entered
and stored on a microcontroller unit contained within the
spirometer with data entry being via a color touch-screen display
of the spirometer. Alarms/events are scheduled and stored in the
microcontroller unit with data entry via the color touch-screen
display with respect to date and time of day when respiratory tests
are required to be taken by the user and when medications should be
taken by the user. The microcontroller unit automatically causes
the spirometer to issue alarms to remind the user of scheduled
respiratory tests and times to take medication. These alarms can
include both visual displays on the touch screen and audible
sounds. Air flow through an air flow tube of the spirometer is
measured in real-time during a respiratory test and an electronic
digital signal is generated by sensors and forwarded to the
microcontroller unit with respect to measured air flow. The
microcontroller calculates and stores values of different test
parameters measured and/or calculated from the respiratory test
results and displays information concerning test results and/or
test result trends in numerical data form and graphical form to the
user via the color touch screen display. The particular test
parameters, test results, test result trends, and display format is
selectable by the user via use of the touch screen display.
[0013] Preferably, the method includes displaying a home page
display on the touch screen display. The home page includes a
plurality of icons that, when activated by being touched by the
user, activate a function of the spirometer. Examples of functions
include uploading data to a host computer, running a respiratory
test, viewing test result trends, managing medications, and setting
alarms.
[0014] The microcontroller unit determines predicted values of the
test parameters based on the stored information of the user's age,
gender, height, weight and ethnicity, determines and displays a
percentage of the predicted value for each test parameter measured,
and determines and displays a severity of each test parameter
measured. In addition, when test results are displayed on the touch
screen display, the test results are color-coded such that any test
result determined to be of high severity by the microcontroller
unit is automatically displayed in red or in flashing red to alert
the user of the high severity of the test result.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The features of the present invention should become apparent
from the following description when taken in conjunction with the
accompanying drawings, in which:
[0016] FIG. 1 is a plan view showing a front panel a spirometer
according to the present invention;
[0017] FIG. 2 is an elevational view of a proximal, top,
mouth-piece end of the spirometer of FIG. 1;
[0018] FIG. 3 is a side elevational view of the spirometer of FIG.
1;
[0019] FIG. 4 is an elevational view of a distal, bottom end of the
spirometer of FIG. 1 opposite the mouth-piece end;
[0020] FIG. 5 is a view of the rear panel of the spirometer of FIG.
1 opposite the front panel;
[0021] FIG. 6 is a cross-sectional view along line 6-6 of FIG.
1;
[0022] FIG. 7 is a plan view of the spirometer of FIG. 1 in which
the coaching mechanism on the front display face is off or in an
initial condition;
[0023] FIG. 8 is a plan view of the spirometer of FIG. 1 in which
the coaching mechanism on the front display face shows progression
during an Exhalation Mode or an Inhalation Mode;
[0024] FIG. 9 is a cross-sectional view along line 9-9 of FIG.
1;
[0025] FIG. 10 is a magnified view showing a pair of turbine
rotation sensors that detect rotation of a rotor within an air flow
tube of the spirometer of FIG. 1;
[0026] FIG. 11 is a view showing the pair of turbine rotation
sensors of FIG. 10 in which a vane of the rotor blocks a beam of
electromagnetic radiation, such as a beam of infrared radiation,
from being received by a receiving sensor;
[0027] FIG. 12 is a view showing the pair of turbine rotation
sensors of FIG. 10 in which the beam of electromagnetic radiation,
such as a beam of infrared radiation, passes by the vane of the
rotor and is received by the receiving sensor;
[0028] FIG. 13 is a cross-sectional view showing a restricted
aperture provided in a wall of the air flow tube adjacent the
receiving sensor;
[0029] FIG. 14 is a magnified view of the restricted aperture and
receiving sensor;
[0030] FIG. 15 is a view showing the pair of sensors positioned
inside of the spirometer of FIG. 1;
[0031] FIG. 16 is a screen shot image provided by the display
screen of the spirometer of FIG. 1 providing visual instructions
with respect to using the device;
[0032] FIG. 17 is a screen shot image provided by the display
screen of the spirometer of FIG. 1 providing an example of a
display of graphical data; and
[0033] FIG. 18 is a screen shot image provided by the display
screen of the spirometer of FIG. 1 providing an illustration of a
person in proper position for taking a test.
DETAILED DESCRIPTION OF THE INVENTION
[0034] The basic exterior structure of a spirometer 10 according to
the present invention is best illustrated in FIGS. 1-5. From the
drawings, the spirometer 10 can have a relatively thin, elongate,
rectangular casework or housing 12 that can be made, for instance,
of plastic, metal, composite material, or the like. Of course,
other shapes and materials for the casework housing 12 can be
utilized. The illustrated embodiment is designed such that it is
portable, lightweight and compact and provides a hand-held,
battery-powered device suitable for home or personal use, although
not limited to such use. The overall size of the spirometer 10 is
such that it can be readily stored in a handbag, drawer or the like
and/or can be carried and taken with the patient as needed.
[0035] The front panel 14 of the spirometer includes a display
screen 16 and can also have a coaching mechanism/indicator 18, and
the rear panel 20 defines the location of an air flow tube 22 that
extends at a central location across the spirometer 10 from a
proximal top end 24 to a distal bottom end 26. A mouthpiece 28 is
located on the end of the air flow tube 22 and extends forward of
the proximal top end 24 of the spirometer 10. The mouthpiece 28 can
be made of transparent material for ease of cleaning and have an
ergonomic design that provides comfort during use. The spirometer
10 can also include a power button 30 and a connection port 32,
such as a micro USB port, on the proximal top end 22 and a
speaker/grill 34 and removable battery compartment panel door 36 on
the rear panel 20. The batteries (not shown) can be rechargeable,
and the spirometer 10 can also be powered via use of an AC power
adaptor.
[0036] The casework housing 12 includes a pair of oppositely
located handgrips 38 that extend on opposite sides 40 of the
spirometer 10 and that form the side edges of the spirometer 10. In
addition, the casework housing 12 includes a finger-receiving
throughhole 42 adjacent each handgrip 34. Each throughhole 42
permits the fingers of the person gripping the spirometer 10 to
extend completely around the handgrips 38 such that each handgrip
38 can be tightly gripped and squeezed in the hand of the user. As
best illustrated in FIG. 5, each handgrip 38 is generally elongate
and extends substantially along and in the same
direction/orientation as the air flow tube 22, and each handgrip 38
can be equally spaced from the centrally located air flow tube 22.
Also, as best illustrated in FIG. 3, the central
longitudinally-extending axis of each of the handgrips 38 and the
central longitudinally-extending axis of the air flow tube 22 are
essentially aligned and coplanar (i.e., extend substantially within
the same imaginary plane). According to one contemplated
embodiment, the outer surface layer of each handgrip 38 is textured
to provide a non-slip surface and is made of rubber, an elastomeric
material, or the like that is at least slightly deformable and
elastic such that the handgrips 38 can be squeezed in the grip of
the user.
[0037] The configuration of the handgrips 38 of the spirometer 10
provides an important function in properly positioning the user to
ensure maximize respiratory effort and results during a respiratory
test. In use, preferably the user sits or stands with their back in
a generally upright position and with shoulders arched backward
(i.e., not in a slumped forward position) with good posture. The
user grips the spirometer 10 tightly with both hands as best
illustrated in FIGS. 16 and 18. Thus, one hand of the user grips
one of the handgrips 38 with the fingers of the user extending
completely through the adjacent throughhole 42 such that user's
hand completely encircles and girds the handgrip 38, and the other
hand of the user grips the other handgrip 38 with the fingers of
the user extending completely through the adjacent throughhole 36
such that user's hand completely encircles and girds the handgrip
38. In this position, the shoulders of the user are flexed backward
and the arms of the user extend laterally and generally
horizontally with bent elbows of the user pointing laterally and
outward. In this balanced and proper posture position, the chest of
the user is generally "open" and ready for maximize inhalation
and/or exhalation.
[0038] Thus, for example, the user takes a deep breath while in the
above described position, places his/her mouth about the mouthpiece
28, and exhales into the air flow tube 22 of the spirometer 10 as
hard as possible for as long as possible to generate meaningful and
valid test results which are measured and stored by the spirometer
10. The spacing and angle between the opposite handgrips 38 and the
position of the handgrips 38 relative to the air flow tube 22 of
the spirometer 10 ensure maximum thoracic cage compactness of the
user so that maximum effort can be applied and meaningful results
can readily be obtained in a reproducible manner. Thus, the above
referenced configuration of the handgrips 38 and spirometer 10
optimizes user position and posture so that the best test results
and readings can be obtained according to the best human
factors.
[0039] In addition, the handgrips 38 can be made of a
squeezable/elastically deformable material that provides a
squeezing sensation to the user when tightly gripped enhancing the
ability of the user to tighten the muscles in their arms, shoulders
and back so that a deep breath can be taken before fully exhaling
into the spirometer 10 or so that the user can fully inhale through
the air flow tube. All of the above induces the strongest breathing
possible by the patient to ensure meaningful and valid results are
obtained in a reproducible manner.
[0040] Another aspect of the spirometer 10 of the present invention
is that it includes a mechanism that provides real-time, automatic
coaching and assistance to the user with respect to the expected
duration of full expiration and/or inhalation. Thus, this mechanism
provides a further means to ensure that the best possible test
results are obtained by providing meaningful information to the
user in real-time, for instance, while the user is exhaling into
the spirometer 10 during a test. More specifically, the spirometer
10 includes the coaching mechanism/indicator 18 on the front panel
14 which is in full view by the user as the user is exhaling into
the spirometer 10 or inhaling through the spirometer 10.
[0041] According to one contemplated embodiment, the indicator 18
is in the form of an elongate continuous or discontinuous line or
sequence of light such as provided, for instance, by a light pipe,
a series or array of light-emitting diodes (LEDs), or like visual
indicator. Other visual effects can also be used such as images or
the like, and the display screen 16 can be used for this purpose.
An audible indicator (such as sounds emitted from the speaker/grill
34) can be used simultaneously in conjunction with the visual
indicator 18 or in place of the visual indicator 18 for providing
the same general purpose.
[0042] The visual indicator 18 can be specifically used to reflect
the expected Force Vital Capacity (FVC) (i.e., the total volume of
air that can be forcibly blown out after full inspiration) of the
patient or the expected Inspiratory Vital Capacity (IVC) (i.e., the
total volume of air that can be inhaled after full exhalation). For
instance, the user's age, height, weight, gender and ethnicity are
entered into the spirometer 10 via use of the display screen 16,
which for example can be a color touch-screen LCD display, and
these entries can be stored in a microprocessor and/or other
electronic memory provided within the spirometer 10. Alternatively,
these data entries can be input into the spirometer 10 via an
external computer connected to the spirometer 10 via the connection
port 32, which can be a micro USB port. From this information, the
microprocessor of the spirometer 10 calculates a Predicted Force
Vital Capacity (PFVC) and/or a Predicted Inspiratory Vital Capacity
(PIVC) expected for a person of the age, height, weight, gender and
ethnicity entered and sets this as the value required to fully
light the visual indicator 18 thereby providing an indication to
the user in real-time of the duration of exhalation or inhalation
sufficient to generate valid test results.
[0043] In use, before a user exhales (or inhales) into the
spirometer 10, the elongate visual indicator 18 is completely unlit
or "off" as best illustrated in FIG. 7. However, as the user begins
exhaling (or inhaling) into the air flow tube 22 of the spirometer
10, the total volume of air flowing through the tube is
continuously measured in real-time during the test, and the
proportion of the Predicted Force Vital Capacity (or Predicted
Inspiratory Vital Capacity) measured based on the real-time
calculation is determined and reflected in the extent to which the
visual indicator 18 is lit or "on". Thus, one end of the visual
indicator 18 will become lit, and as the user continues to exhale
(or inhale) into the spirometer 10, progressively more of the
visual indicator 18 will light-up as best shown in FIG. 8, until
the entire indicator 18 is lit or "on". In this manner, the
indicator 18 coaches and provides incentive to the user to continue
to exhale (or inhale) into the air flow tube 22 at least until the
full length or a pre-determined length of the visual indicator 18
is lit which reflects the predicted volume of air expected during
full exhalation (or full inhalation) by the particular patient.
Thus, the patient is coached to "don't stop, keep going" by the
coaching mechanism 18 and the user can view the indicator 18 during
a test so that meaningful and reproducible results can be
obtained.
[0044] According to one contemplated embodiment, the spirometer 10
of the present invention measures the flow of air through the air
flow tube 22 with a turbine assembly 44 and at least a pair of
oppositely located rotation-detecting sensors 46. The air flow tube
22 and turbine assembly 44 are best illustrated in FIG. 6.
[0045] The air flow tube 22 generally includes the mouthpiece 28
and a turbine tube 48 which are connected end-to-end by the housing
12 with a mesh protective screen 50 or the like provided
therebetween. The mesh screen 50 prevents foreign objects from
entering and possibly damaging the turbine assembly. The mouthpiece
28 can be removable from the spirometer 10 for cleaning and/or
replacement purposes.
[0046] A vane 52 is mounted for rotation on a spindle 54 within the
turbine tube 48 between a series of stationary air flow deflectors
68. The opposite ends of the spindle 54 are positioned and ride
within vee jewel assemblies 70 that enable the spindle 54 to rotate
about its longitudinal axis within the turbine tube 48. The vee
jewel assemblies 70 are high precision spring-loaded bushings that
greatly reduce friction thereby permitting high revolutions per
minute (RPMs) to be achieved by the vane 52 and spindle 54. Thus,
when the user exhales (expires) or inhales (inspires) into/out of
the air flow tube 22, the flow of air through the turbine tube 48
will cause the vane 52 and spindle 54 to rotate. The vane 52 will
rotate faster when the speed of the air flow is greater, and the
vane 52 will rotate slower when the speed of air flow decreases. In
addition, the direction of rotation of the vane 52 and spindle 54
can be monitored to determine whether the patient is exhaling or
inhaling into the spirometer 10.
[0047] The rotation of the vane 52 is monitored by the
rotation-detecting sensors 46 mounted in opposite positions
relative to the turbine tube 48. The sensors 46 are best
illustrated in FIGS. 9-15. One of the sensors 46 can include a
transmitter for transmitting a beam of visible or invisible light
or electromagnetic radiation and a receiver for receiving/detecting
the presence or absence of the beam at the receiver location. By
way of example, the sensors 46 can include a diode for emitting a
beam of infrared radiation or light (invisible to the human eye)
and a photo-transistor that detects the presence or absence of the
infrared light beam.
[0048] As best illustrated in FIG. 10, the sensors 46 can be
mounted at opposite positions about the turbine tube 48. In this
position, a beam of infrared radiation or light, or some other beam
of electromagnetic radiation, can be emitted transversely across
and within the tube at the location of vane 52. In this manner,
rotation of the vane 52 can interrupt the beam (see FIG. 11) or
permit the beam to pass (see FIG. 12) depending upon the relative
angular position of the rotating vane 52 at any instance of
time.
[0049] The number of times the beam is interrupted by the vane 52
is equivalent to an accumulated angle of rotations of the vane 52,
and therefore, the volume of air to pass through the turbine tube
48 can be readily determined since the dimensions of the turbine
tube is known and since the speed of air flow is measured. The
receiving sensor, such as a photo-transistor, produces a digital
electrical output signal corresponding to the receipt of the beam
and interruptions thereof. This digital signal is provided to the
microprocessor or microcontroller within the spirometer 10 and can
be used by the microprocessor or microcontroller to calculate, in
real-time, the amount or volume of air flow during an inhalation or
exhalation test. The flow can be measured on a timed basis, and the
microprocessor can convert this information to an accumulated
volume based on formulae in microcontroller firmware. For example,
when the patient is exhaling into the spirometer 10, the
accumulated volume measurement is equivalent to a measurement of
Forced Vital Capacity (FVC), or when the patient is inhaling
through the spirometer 10, the accumulated volume measurement is
equivalent to a measurement of Inspiratory Vital Capacity (NC).
[0050] As discussed above, the spirometer 10 can already have
calculated the Predicted Forced Vital Capacity (PFVC), and the
microprocessor or microcontroller can divide the FVC measured at
any instance of time in real-time by the PFVC to produce a
percentage of PFVC used to progressively light the indicator 18
discussed above. Also, if the patient inspires (inhales) into the
spirometer 10, an accumulated volume of air flow can be determined
and provide a measure of Inspiratory Vital Capacity (NC). The
spirometer 10 can calculate a Predicted Inspiratory Vital Capacity
(PIVC), and the microprocessor or microcontroller can divide the
IVC measured at any instance of time in real-time by the PIVC to
produce a percentage of PIVC used to progressively light the
indicator 18 discussed above.
[0051] As best illustrated in FIGS. 10-12, the sensors 46 are
located external of the turbine tube 48 and apertures, such as
aperture 56 best shown in FIG. 13, are formed in the wall of the
turbine tube 48. Infrared light emitted from a light emitting diode
(LED), for example, typically does not form a narrow line beam
along its full path; rather, it typically is emitted in the form of
a spherical cone that expands, for instance, at about plus or minus
20.degree.. Thus, as the light travels from the LED, the beam
widens and expands forming a spherical cone-shaped beam. This wide
angle often increases unwanted reflections within the surrounding
enclosure, such as reflections off the walls of the turbine tube
48. Accordingly, a shroud 58 can be provided about each sensor 46
or at least in front of each sensor 46 and provide a narrow
slit-shaped aperture 60 directly in front of each sensor 46
exterior of the turbine tube 48. The apertures 60 limit the angle
and shape of the infrared light beam crossing the turbine tube 48
and limit the ability of a reflection from being received by the
receiving sensor. Preferably, the widening of the beam as it
extends from the LED is limited to a predetermined effective angle.
Merely for purposes of example, the effective angle can be plus or
minus 2.degree., or in a range of 1.degree. to 5.degree., or any
other angle or range of angles. Limiting the effected angle
optimizes the light received by the receiving sensor when the
receiving sensor is to properly receive the beam and further
minimizes internal optical reflections at all times to prevent
inaccurate readings caused by reflections. By way of example, the
aperture 60 can have one end 62 formed as a semicircle of a radius
of about 1 mm and an opposite squared-off end 64. See FIG. 14.
[0052] The operation of the spirometer 10 can be controlled by
software, firmware or the like contained within the spirometer 10
via a microprocessor, microcontroller unit, or the like.
Preferably, the display screen 16 is a touch screen used to display
various icons or the like that can be touched to activate a
specific function. Thus, the software receives the user's inputs
via the touch screen and provides an appropriate response via
displaying further information on the display screen 16.
[0053] By way of example, the spirometer 10 can normally display a
home screen having a plurality of icons which can include, for
instance, an upload data icon, a run test icon, a view trends icon,
a manage medicines icon, and a set alarm icon. Any of these icons
can be touched by the user to activate the corresponding
programming of the spirometer. The home screen can also include a
battery icon showing the status of charge of the rechargeable
battery and a scrollable display of a list of upcoming scheduled
events or alarms with respect to when respiratory tests are
scheduled to be run and when medications are scheduled to be taken.
Of course, the time, date and day of the week can also be
displayed.
[0054] When it is time for a scheduled event or alarm, a pop-up
screen appears on the touch screen display 16 and requests the
patient to run a test, take a medicine, or dismiss the event/alarm.
An audible alarm can simultaneously be generated to also remind the
patient of the need to take a test or medicine. By way of example,
if the user presses the run test icon in the pop-up screen or the
home screen, the display screen 16 will appear as shown in FIG. 16.
This provides instructions to the user with respect to the desired
test. As shown in FIG. 16, the user is shown how to hold the
spirometer and is instructed to take a deep breath and then exhale
into the spirometer (or fully inhale through the spirometer
depending on the test). Typically, the spirometer will require the
user to take three identical tests and will instruct the user with
respect to the additional tests. If any of the tests are
incorrectly performed, the spirometer will provide instructions
with respect to re-taking the test.
[0055] After a test is successfully completed, including all three
test trials, the best test results of the trials will be displayed
on the display screen 16 of the spirometer. By way of example, this
may include values for FVC, FEV1, FEV1/FVS, FEF 25-75, and PEF. Of
course, other or different values can be displayed depending upon
the particular test taken, for example a value of IVC may be
provided. The percentage of these test values relative to that
predicted for the patient (i.e. based on age, gender, height,
weight and ethnicity) can also be displayed on the screen. Further,
the "severity" of each of these values can be listed (i.e. "high",
"normal", "moderate", "mild", "low", "etc.). The user is also
provided with additional icons with respect to uploading the data
to an external host computer, viewing graphical results of the
test, and viewing trend data which is a log of all test data taken
to date or within a selected date range.
[0056] When the user presses the view trends icon on the touch
screen display 16, the screen lists the results of all tests taken
along with the time and date of each test and permits the user to
scroll through the complete listing. The user can limit this
listing to a particular date range, if desired. In addition, the
user can limit the listing to any particular test value, such as
those discussed above. Preferably, the display screen 16 is a color
screen and any test result considered of a "high" severity is
displayed in red or in flashing-red to draw quick attention to the
particular result.
[0057] The user can press the view graphical results for any
particular test and for any particular value. For example, FIG. 17
shows the display screen 16 showing trend data for FEF 25-75
measurements. Since the display is a color display, the different
parts of the graph are color-coded. For instance, the part of the
graph representing "normal" can be color-coded green, the part of
the graph representing "mild" severity can be color-coded
light-green, the part of the graph representing "moderate" severity
can be color-coded orange, and the part of the graph representing
"high" severity can be color-coded red. For example, as shown in
FIG. 16, the test results were initially normal, fell to "moderate"
severity and more recently show "mild" severity.
[0058] The above style graph can be shown for any test or for any
particular test values. In addition, the user can view flow-volume
loops and volume-time curves for each test. Thus, the spirometer
stores a number of tests and the test results can be viewed in
numerical raw data format or in graphical format. By way of
example, the spirometer can store up to 180 test results, 180
flow-volume loops, and 180 volume-time loops in internal memory. Of
course, this memory can be increased to store a greater number of
test results and the like.
[0059] When the user activates the manage medicines icon, the
display screen provides a scrollable list of prescribed medicines
along with the dosage and start and end dates. When the user
selects a particular medicine, the scheduled times and dates to
take the medicine is displayed. This screen also allows the user to
enter a new medication to the list, check the medication schedule,
view the medication history for medications already taken, and log
an entry with respect to providing an acknowledgement that a
medication was taken.
[0060] When the user activates the upload data icon, the display
screen 16 provides instructions with respect to connecting a cable,
such as a USB cable, to the connection port 32 of the spirometer 10
and to connect the cable to the external host computer. The
particular data desired for upload can be selected and the data can
be uploaded so that, for instance, the data can be viewed by a
physician or the like.
[0061] In addition to the above, the device settings of the
spirometer can be adjusted, such as, brightness of display, volume
level/mute, time/daylight savings time, format of date, unit of
measure (English, metric), language (English, Spanish, etc.), and
font size of letters appearing in the display (large, small). The
patient can also be initially prompted to enter their name, date of
birth, gender, height, weight, and ethnicity and this information
is saved in memory. Finally, the patient or caregiver can set up
any number of alarms with respect to taking respiratory tests
and/or medications at any desired time or times of day and for any
days specified.
[0062] Accordingly, the user is provided with a tool that informs
the patient with an alarm when to take respiratory tests and/or
medications and instructions on how to take the tests. The
structure of the spirometer ensures that reliable, valid and
meaningful test results are taken, and all test results are
electronically stored and can be viewed in numerous formats. Test
results that are considered to be of "high" severity can be
displayed in red or flashing red to draw quick attention to such
results. The trends of the tests over a period of time can be
viewed to see if the results are improving, staying the same, or
becoming worse. Medication history of medicines taken can be
viewed, and a schedule of medications to be taken can be viewed.
All the above can be readily uploaded into a host computer, such as
a computer of a physician, so that the physician can track the
progress of treatment. Also, all operations of the spirometer can
be controlled via selecting icons or the like on a touch screen
color display panel.
[0063] While preferred spirometers, methods, systems and software
have been described in detail, various modifications, alterations,
and changes may be made without departing from the spirit and scope
of the present invention as defined in the appended claims.
* * * * *