U.S. patent application number 12/857925 was filed with the patent office on 2010-12-09 for respiratory therapy device and method.
This patent application is currently assigned to CareFusion 2200, Inc.. Invention is credited to Thomas J. Dunsmore, Christoph L. Gillum, Christopher J. Matice, Shannon Rice Read, Thomas C. Wilschke, Geoffrey C. Wise.
Application Number | 20100307487 12/857925 |
Document ID | / |
Family ID | 39367999 |
Filed Date | 2010-12-09 |
United States Patent
Application |
20100307487 |
Kind Code |
A1 |
Dunsmore; Thomas J. ; et
al. |
December 9, 2010 |
RESPIRATORY THERAPY DEVICE AND METHOD
Abstract
A respiratory therapy device including a housing and an
interrupter valve assembly. The housing includes a patient inlet,
an exhaust outlet, a chamber, and a supply inlet. The interrupter
valve assembly is associated with the housing and includes a
control port fluidly connecting the patient inlet and the first
chamber, and a valve body adapted to selectively obstruct fluid
flow through the control port. In a passive mode, positive fluid
flow to the supply inlet does not occur, and the interrupter valve
assembly interacts with exhaled air create an oscillatory PEP
effect. In an active mode, fluid flow to the supply inlet occurs
and the interrupter valve assembly operates to create a CHFO
effect. The respiratory device can serve as a passive oscillatory
PEP device, and when connected to a positive pressure source, as an
active device.
Inventors: |
Dunsmore; Thomas J.;
(Glendora, CA) ; Wise; Geoffrey C.; (Benicia,
CA) ; Wilschke; Thomas C.; (Riverside, CA) ;
Matice; Christopher J.; (Bellbrook, OH) ; Gillum;
Christoph L.; (Middletown, OH) ; Read; Shannon
Rice; (Lebanon, OH) |
Correspondence
Address: |
DICKE, BILLIG & CZAJA, PLLC;ATTN: CFN MATTERS
100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS
MN
55402
US
|
Assignee: |
CareFusion 2200, Inc.
San Diego
CA
|
Family ID: |
39367999 |
Appl. No.: |
12/857925 |
Filed: |
August 17, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11559288 |
Nov 13, 2006 |
7779841 |
|
|
12857925 |
|
|
|
|
Current U.S.
Class: |
128/200.23 ;
128/205.24 |
Current CPC
Class: |
A61M 16/0006 20140204;
A61M 16/20 20130101; A61M 16/202 20140204; A61M 11/00 20130101;
A61M 16/209 20140204; F01C 1/123 20130101; F01C 20/24 20130101;
A61M 16/208 20130101; A61M 16/00 20130101; F01C 13/00 20130101 |
Class at
Publication: |
128/200.23 ;
128/205.24 |
International
Class: |
A61M 16/20 20060101
A61M016/20; A61M 11/00 20060101 A61M011/00 |
Claims
1. A device for providing respiratory therapy to a patient during
at least a portion of a patient breathing cycle including an
inspiratory phase and an expiratory phase, the device comprising: a
housing including a patient inlet, an exhaust outlet, first and
second chambers fluidly disposed between the patient inlet and the
exhaust outlet, and a first pressurized fluid supply inlet; an
interrupter valve assembly associated with the housing and
including a control port fluidly connecting the patient inlet and
the first chamber, and a valve body adapted to selectively obstruct
fluid flow through the control port; and a control assembly
associated with the housing and including a passage connecting the
first chamber and the second chamber, the control assembly adapted
to selectively open and close the passage.
2. The device of claim 1, wherein the device is adapted to: operate
in a first, passive mode when the passage is open in which fluid
flow to the first pressurized fluid supply inlet does not occur and
the interrupter valve assembly interacts with exhaled air to create
an oscillatory positive expiratory pressure effect during the
expiratory phase, and operate in a second, active mode when the
passage is closed in which fluid flow to the pressurized fluid
supply inlet occurs and the interrupter valve assembly interacts
with the fluid flow to create a continuous high frequency
oscillation effect.
3. The device of claim 1, wherein the interrupter valve assembly
includes a plurality of control ports and the valve body is
configured to selectively obstruct respective ones of the control
ports.
4. The device of claim 1, wherein the interrupter valve assembly
further includes a rotatable drive shaft maintaining the valve body
such that rotation of the drive shaft causes the valve body to
selectively obstruct the control port.
5. The device of claim 4, wherein the interrupter valve assembly
further includes a drive mechanism for rotating the drive
shaft.
6. The device of claim 5, wherein the drive mechanism includes
first and second lobe bodies maintained within the second
chamber.
7. The device of claim 6, wherein fluid flow from the first chamber
to the second chamber acts upon the lobe bodies to cause rotation
thereof.
8. The device of claim 7, wherein the second chamber forms an
outlet opening fluidly connected to the exhaust outlet.
9. The device of claim 7, wherein the housing further forms a
relief port arrangement in the first chamber apart from the control
port, the device further including a valve structure controlling
fluid flow through the relief port arrangement such that when a
fluid pressure within the first chamber exceeds a predetermined
level, the valve structure fluidly opens the relief port
arrangement.
10. The device of claim 9, wherein the housing further forms an
exhaust chamber defining the exhaust outlet and fluidly connected
to the first chamber via the relief arrangement.
11. The device of claim 10, wherein the exhaust chamber is fluidly
connected to the second chamber via an outlet opening.
12. The device of claim 1, wherein the first pressurized fluid
inlet is fluidly connected to the first chamber.
13. The device of claim 12, wherein the device further includes a
nozzle having an inlet side fluidly open to the first pressurized
fluid inlet and an outlet side fluidly open to the control port,
and further wherein the valve body is movable between the nozzle
outlet side and the control port to selectively obstruct fluid flow
from the nozzle outlet side to the control port.
14. The device of claim 13, wherein the interrupter valve assembly
further includes a drive shaft carrying the valve body such that
with rotation of the drive shaft, the valve body selectively covers
the control port, and a drive mechanism for rotating the drive
shaft.
15. The device of claim 14, wherein at least a portion of the drive
mechanism is maintained in the second chamber and, a second
pressurized fluid supply inlet fluidly connectable to a source of
pressurized fluid is formed in the housing, and further wherein in
the device is adapted such that in the active mode, fluid flow from
the second pressurized fluid supply inlet to the second chamber
drives the drive mechanism.
16. The device of claim 15, wherein the drive mechanism includes
first and second lobe bodies maintained in the second chamber.
17. The device of claim 16, wherein the control assembly includes:
a plate disposed between the first and second chambers for
selectively opening and closing the passage.
18. The device of claim 1, wherein the housing further forms an
inhalation relief port arrangement and the device further includes
a one-way valve structure assembled to the inhalation relief port
arrangement for permitting flow of ambient air into the patient
inlet during the inspiratory phase.
19. The device of claim 1, wherein the interrupter valve assembly
further includes a locking mechanism for selectively locking the
valve body in an open position in which the control port is open
such that the device is operable in a third, continuous mode in
which positive fluid flow to the pressurized fluid supply inlet
occurs to create a continuous positive airway pressure effect.
20. The device of claim 1, wherein the interrupter valve assembly
further includes a drive mechanism for controlling a position of
the valve body relative to the control port, the drive mechanism
including a cantilever beam.
21. The device of claim 20, wherein the drive mechanism further
includes a vibrating motor mounted to a leading end of the
beam.
22. A method of providing respiratory therapy to a patient during
at least a portion of a patient breathing cycle including an
inspiratory phase and an expiratory phase, the method comprising:
providing a respiratory therapy device including: a housing
including a patient inlet, an exhaust outlet, first and second
chambers fluidly disposed between the patient inlet and the exhaust
outlet and a pressurized fluid supply inlet, and an interrupter
valve assembly for selectively interrupting fluid flow to or from
the patient inlet, and a control assembly associated with the
housing and including a passage connecting the first chamber and
the second chamber; and selectively operating the control assembly
to open the passage in a passive mode of operation and close the
passage in an active mode of operation.
23. The method of claim 22, wherein the passive mode of operation
is characterized by a level of oscillatory positive expiratory
pressure therapy being a function of a breathing effort of the
patient.
24. The method of claim 22, wherein the active mode of operation is
characterized by a level of continuous high frequency oscillation
therapy being independent of a breathing effort of the patient.
25. The method of claim 22, wherein the interrupter valve assembly
includes at least one control port fluidly connecting the patient
inlet with a chamber, a valve body selectively obstructing the
control port, and a drive mechanism controlling a position of the
value body relative to the control port, and further wherein
administering oscillatory positive expiratory pressure therapy
includes actuating the drive mechanism in response to expiratory
airflow from the patient.
26. The method of claim 25, wherein the drive mechanism includes
first and second lobe assemblies, the first lobe assembly
maintaining the valve body, and further wherein administering
oscillatory positive expiratory pressure therapy includes
expiratory airflow from the patient causing the lobe assemblies to
rotate.
27. The method of claim 22, wherein the pressurized fluid supply
inlet is fluidly connected to the interrupter valve assembly, and
the interrupter valve assembly includes at least one control port
fluidly connecting the patient inlet with a chamber, a valve body
selectively obstructing the control port, and a drive mechanism
controlling a position of the valve body relative to the control
port, and further wherein administrating continuous high frequency
oscillatory therapy includes fluid flow from the pressurized fluid
source actuating the drive mechanism.
28. The method of claim 22, further comprising: selecting a mode of
operation of the device prior to administering a therapy and
operating the control assembly based on the selected mode of
operation.
29. The method of claim 28, wherein the control assembly further
includes a control tab selectively opening and closing the passage,
and further wherein selecting a mode of operation includes changing
a position of the control tab relative to the passage.
30. The method of claim 22, further comprising: locking the
interrupter valve assembly in an open state; fluidly coupling the
source of pressurized fluid to the pressurized fluid supply inlet;
and administering continuous positive airway pressure therapy to
the patient via the device in a CPAP mode of operation.
31. The method of claim 30, wherein the CPAP mode of operation is
characterized by the interrupter valve assembly remaining
stationary.
32. The method of claim 22, wherein the device further includes a
nebulizer port fluidly coupled to the patient inlet fluidly between
an inlet end of the patient inlet and the interrupter valve
assembly, the method further comprising: fluidly coupling a
nebulizer to the nebulizer port; and supplying aerosolized fluid to
the patient during at least one of the active mode of operation and
the passive mode of operation.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/559,288, entitled "Respiratory Therapy
Device and Method" filed on Nov. 13, 2006 and related to U.S. Ser.
No. 11/670,867, entitled "Respiratory Therapy Device and Method"
filed on Feb. 2, 2007; the teachings of which are both incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present disclosure relates to respiratory therapy
devices and methods for administering breathing-relating treatments
(e.g., oscillatory, continuous, etc.) to a patient. More
particularly, it relates to respiratory therapy devices capable of
creating oscillatory respiratory pressure pulses in response to the
patient's expiratory airflow alone, or when connected to a source
of positive pressure fluid (e.g., air, oxygen, etc.), or both. One
or more additional therapies (e.g., continuous positive airway
pressure, continuous positive expiratory pressure, delivery of
aerosolized medication, etc.) are optionally available in some
embodiments.
[0003] A wide variety of respiratory therapy devices are currently
available for assisting, treating, or improving a patient's
respiratory health. For example, positive airway pressure (PAP) has
long been recognized to be an effective tool in promoting bronchial
hygiene by facilitating improved oxygenation, increased lung
volumes, and reduced venous return in patients with congestive
heart failure. More recently, positive airway pressure has been
recognized as useful in promoting mobilization and clearance of
secretions (e.g., mucous) from a patient's lungs. In this regard,
expiratory positive airway pressure (EPAP) in the form of high
frequency oscillation (HFO) of the patient's air column is a
recognized technique that facilitates secretion removal. In general
terms, HFO reduces the viscosity of sputum in vitro, which in turn
has a positive effect on clearance induced by an in vitro simulated
cough. In this regard, HFO can be delivered or created via a force
applied to the patient's chest wall (i.e., chest physical therapy
(CPT), such as an electrically driven pad that vibrates against the
patient's chest), or by applying forces directly to the patient's
airway (i.e., breathing treatment, such as high frequency airway
oscillation). Many patients and caregivers prefer the breathing
treatment approach as it is less obtrusive and can more easily be
administered. To this end, PAP bronchial hygiene techniques have
emerged as an effective alternative to CPT for expanding the lungs
and mobilizing secretions.
[0004] In the context of high frequency oscillatory breathing
treatments, various devices are available. In general terms,
respiratory therapy devices typically include one or more tubular
bodies through which a patient breaths, with the tubular body or
bodies creating or defining a patient breathing circuit. With this
in mind, the oscillatory airflow effect can be created by
periodically generating a pressure or positive airflow in the
patient breathing circuit during one or both of an inspiratory
phase or expiratory phase of the patient's breathing cycle. For
example, a positive expiratory pressure (PEP) can work "against"
the patient's breath during the expiratory phase of breathing. The
pressure can be generated by creating a periodic (or in some
instances continuous) resistance or restriction in the patient
breathing circuit to expiratory airflow from the patient, or by
introducing a forced fluid flow (from a positive pressure gas
source) into the patient's breathing circuit in a direction
opposite of the patient's exhaled air. With the airflow resistance
approach, a separate, positive pressure gas source is not required.
More particularly, many oscillatory positive expiratory pressure
("oscillatory PEP") therapy devices utilize the patient's breath
alone to drive an oscillatory fluid flow restriction, and thus can
be referred to as "passive" devices (in contrast to an "active"
respiratory therapy device that relies on a separate source of
positive pressure gas as described below). Passive oscillatory PEP
devices are self-administering and portable.
[0005] The Flutter.RTM. mucus clearance device (available from
Axcan Scandipharm Inc., of Birmingham, Ala.), is one example of an
available passive, oscillatory PEP therapy device. In general
terms, the Flutter device is pipe-shaped, with a steel ball in a
"bowl" portion of a housing that is loosely covered by a perforated
cap. The ball is situated within an airway path defined by the
device's housing; when the patient exhales into the housing, then,
the ball temporarily obstructs airflow, thus creating an expiratory
positive airway pressure. The bowl within which the ball is located
allows the ball to repeatedly move (e.g., roll and/or bounce) or
flutter to create an oscillatory or vibrational resistance to the
exhaled airflow. While relatively inexpensive and viable, the
Flutter device is fairly sensitive, requiring the patient to
maintain the device at a particular angle to achieve a consistent
PEP effect. Other passive oscillatory positive expiratory pressure
devices, such as the Acapella.RTM. vibratory PEP therapy system
(available from Smiths Medical of London, England) and the
Quake.RTM. secretion clearance therapy device (available from
Thayer Medical Corp., of Tucson, Ariz.) are known alternatives to
the Flutter device, and purport to be less sensitive to the
position in which the patient holds the device during use. While
these and other portable oscillatory PEP therapy devices are
viable, opportunities for improvement remain, and patients continue
to desire more uniform oscillatory PEP results.
[0006] As an alternative to the passive oscillatory PEP devices
described above, continuous high frequency oscillatory (CHFO)
treatment systems are also available. In general terms, the CHFO
system includes a hand-held device establishing a patient breathing
circuit to which a source of positive pressure gas (e.g., air,
oxygen, etc.), is fluidly connected. The pressure source and/or the
device further include appropriate mechanisms (e.g., control valves
provided as part of a driver unit apart from the hand-held device)
that effectuate intermittent flow of gas into the patient breathing
circuit, and thus percussive ventilation of the patient's lungs.
With this approach, the patient breathes through a mouthpiece that
delivers high-flow, "mini-bursts" of gas. During these percussive
bursts, a continuous airway pressure above ambient is maintained
while the pulsatile percussive airflow periodically increases
airway pressure. Each percussive cycle can be programmed by the
patient or caregiver with certain systems, and can be used
throughout both inspiratory and expiratory phases of the breathing
cycle.
[0007] Examples of CHFO devices include the IPV.RTM. ventilator
device (from PercussionAire Corp., of Sandpoint, ID) and a
PercussiveNeb.TM. system (from Vortran Medical Technology 1, Inc.,
of Sacramento, Calif.). These and other similar "active" systems
are readily capable of providing not only CHFO treatments, but also
other positive airflow modes of operation (e.g., continuous
positive airway pressure (CPAP)). However, a positive pressure
source is required, such that available active respiratory therapy
systems are not readily portable, and are relatively expensive
(especially as compared to the passive oscillatory PEP devices
described above). Oftentimes, then, active respiratory treatment
systems are only available at the caregiver's facility, and the
patient is unable to continue the respiratory therapy at home.
Instead, a separate device, such as a portable, passive oscillatory
PEP device as described above must also be provided. Further, the
hand-held portion of some conventional active respiratory therapy
systems must be connected to an appropriate driver unit that in
turn is programmed to effectuate the desired fluid flow to the
patient (e.g., CHFO, CPAP, etc.). That is to say, the hand-held
portion of some active systems is not self-operating, but instead
relies on the driver unit for applications. Any efforts to address
these and other limitations of available active respiratory therapy
devices would be well-received. This limitation represents a
significant drawback.
[0008] In light of the above, a need exists for respiratory devices
capable of providing oscillatory PEP therapy utilizing the
patient's breath alone, as well as CHFO therapy (and optionally
other therapies such as CPAP) when connected to a positive pressure
source. In addition, improved passive oscillatory PEP or active
respiratory therapy devices are also needed.
SUMMARY OF THE INVENTION
[0009] Some aspects in accordance with principles of the present
disclosure relate to a device for providing respiratory therapy to
a patient during at least a portion of a patient breathing cycle
otherwise including an inspiratory phase and an expiratory phase.
The device includes a housing and an interrupter valve assembly.
The housing includes a patient inlet, an exhaust outlet, a chamber,
and a pressurized fluid supply inlet. The chamber is fluidly
disposed between the patient inlet and the exhaust outlet. The
interrupter valve assembly is associated with the housing and
includes a control port fluidly connecting the patient inlet and
the chamber. Further, the interrupter valve assembly includes a
valve body adapted to selectively obstruct fluid flow through the
control port. With this in mind, the device is adapted to operate
in a first, passive mode and a second, active mode. In the passive
mode, positive airflow to the supply inlet does not occur. The
interrupter valve assembly interacts with exhaled air from the
patient to create an oscillatory positive expiratory pressure
effect during at least the expiratory phase. Conversely, in the
active mode, positive fluid flow to the fluid supply inlet occurs
and the interrupter valve assembly interacts with this fluid flow
to create a continuous high frequency oscillation effect. With this
configuration, then, the respiratory device can serve as a passive,
oscillatory PEP device for use by a patient at virtually any
location. In addition, when connected to a positive pressure gas
source, the respiratory therapy device provides active therapy. In
some embodiments, the interrupter valve assembly includes a drive
mechanism akin to a reverse roots blower, utilizing forced air
(e.g., either the patient's exhaled airflow or airflow from a
separate positive gas source) to cause rotation of the roots blower
lobes, that in turn cause the valve body to periodically open and
close the control port. In other embodiments, the device can
provide or facilitate one or more additional therapies such as
continuous PEP, CPAP, delivery of aerosolized medication, etc.
[0010] Other aspects in accordance with the present disclosure
relate to a method of providing respiratory therapy to a patient
during at least a portion of a patient breathing cycle including an
inspiratory phase and an expiratory phase. The method includes
providing a respiratory therapy device including a housing and an
interrupter valve assembly. The housing includes a patient inlet,
an exhaust outlet, and a pressurized fluid supply inlet. The
interrupter valve assembly is adapted to selectively interrupt
fluid flow to or from the patient inlet. A source of pressurized
fluid is fluidly coupled to the fluid supply inlet. Continuous high
frequency oscillation treatment is administered to the patient via
the therapy device, with the therapy device operating in an active
mode. Fluid flow from the source of pressurized fluid to the fluid
supply inlet is discontinued. The patient is then prompted to
repeatedly perform a patient breathing cycle using the therapy
device. In this regard, the therapy device administers an
oscillatory positive expiratory pressure treatment to the patient
while operating in a passive mode. In some embodiments, the passive
mode of operation is characterized by the level of oscillatory
positive expiratory pressure treatment being a function of a
breathing effort of the patient, whereas the active mode of
operation is characterized by a level of continuous high frequency
oscillation treatment being independent of the patient's breathing
effort. In yet other embodiments, the method further includes
administering one or more additional therapies to the patient via
the device, such as CPAP, continuous PEP, delivery of aerosolized
medication, etc.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a block diagram illustrating a respiratory therapy
device in accordance with principles of the present disclosure;
[0012] FIG. 2 is an exploded, perspective view of a respiratory
therapy device in accordance with principles of the present
disclosure;
[0013] FIG. 3A is a perspective view of a housing portion of the
device of FIG. 2;
[0014] FIG. 3B is a bottom view of the housing of FIG. 3A;
[0015] FIG. 4A is a longitudinal, cross-sectional view of the
housing of FIG. 3A taken along a patient supply inlet;
[0016] FIG. 4B is a rear, perspective view of a leading portion of
the housing of FIG. 3A;
[0017] FIG. 4C is a longitudinal, cross-sectional view of the
housing of FIG. 3A taken along a drive supply inlet;
[0018] FIG. 5A is an exploded, perspective view of a drive
mechanism portion of the device of FIG. 2;
[0019] FIG. 5B is a perspective view of the drive mechanism of FIG.
5A upon final assembly;
[0020] FIG. 6A is a perspective view illustrating partial assembly
of the device of FIG. 2;
[0021] FIG. 6B is a longitudinal, cross-sectional view of the
device of FIG. 2 upon final assembly, taken along a patient supply
inlet;
[0022] FIGS. 7A and 7B illustrate use of the device of FIG. 2 in a
passive mode;
[0023] FIGS. 8A-8C illustrate use of the device of FIG. 2 in an
active mode;
[0024] FIG. 9 is an exploded, perspective view of an alternative
respiratory therapy device in accordance with principles of the
present invention;
[0025] FIG. 10 is a front, plan view of a trailing housing portion
of the device of FIG. 9;
[0026] FIG. 11 is a perspective, cutaway view of a portion of the
device of FIG. 9 upon final assembly;
[0027] FIG. 12 is a exploded, perspective view illustrating
assembly of the device of FIG. 9;
[0028] FIG. 13A is a perspective view of the device of FIG. 9;
[0029] FIG. 13B is a longitudinal, perspective view of the device
of FIG. 9;
[0030] FIGS. 14A and 14B illustrate use of the device of FIG. 9 in
which airflow passes from a patient inlet to a chamber;
[0031] FIGS. 15A and 15B illustrate use of the device of FIG. 9 in
which airflow is obstructed from a patient inlet to a chamber;
[0032] FIG. 16 is a simplified, side sectional view of an
alternative respiratory therapy device in accordance with
principles of the present disclosure;
[0033] FIG. 17 is an exploded, perspective view of another
embodiment respiratory therapy device in accordance with principles
of the present disclosure;
[0034] FIG. 18A is a longitudinal, cross-sectional view of the
device of FIG. 17;
[0035] FIG. 18B is an enlarged view of a portion of FIG. 18A;
[0036] FIGS. 19A and 19B illustrate use of the device of FIG.
17;
[0037] FIG. 20 is a schematic illustration of an interrupter valve
assembly useful with the device of FIG. 17;
[0038] FIGS. 21A and 21B are simplified, schematic illustrations of
an alternative interrupter valve assembly useful with the device of
FIG. 17;
[0039] FIG. 22 is a longitudinal, cross-sectional view of another
embodiment respiratory therapy device in accordance with principles
of the present disclosure;
[0040] FIG. 23A is an exploded, perspective view of another
embodiment respiratory therapy device in accordance with principles
of the present disclosure;
[0041] FIG. 23B is a perspective, cutaway view of the device of
FIG. 23A upon final assembly;
[0042] FIG. 24 is an enlarged, perspective view of an orifice
assembly portion of the device of FIG. 23A;
[0043] FIG. 25 is a schematic, electrical diagram of control
circuitry useful with the device of FIG. 23A;
[0044] FIGS. 26A and 26B illustrate the device of FIG. 23A upon
final assembly;
[0045] FIGS. 27A and 27B illustrate use of the device of FIG. 23A;
and
[0046] FIG. 28 is a longitudinal, cross-sectional view of another
embodiment respiratory therapy device in accordance with principles
of the present disclosure;
DETAILED DESCRIPTION OF THE INVENTION
[0047] In general terms, aspects of the present disclosure relate
to respiratory therapy devices and related methods of use that are:
1) capable of operating in either of an active mode (e.g., CHFO) or
a passive mode (e.g., oscillatory PEP); or 2) improved passive-only
oscillatory PEP devices; or 3) improved active-only devices (CHFO
and/or CPAP). As used throughout this specification, an "active"
therapy device is in reference to a device that requires a separate
source of positive pressure fluid to effectuate a designated
respiratory therapy, whereas a "passive" therapy device is in
reference to a device that delivers a designated respiratory
therapy in and of itself (i.e., a separate source of positive
pressure fluid is not necessary). Thus, an "active-only" therapy
device is one that must be connected to a separate source of
positive pressure fluid. Conversely, a "passive-only" therapy
device is one that is not configured to receive pressurized fluid
from a separate source. Given these definitions, several of the
embodiments associated with this disclosure have base constructions
appropriate for passive-only, oscillatory PEP applications, as well
as modified base constructions that promote use of the device as
either an oscillatory PEP therapy device or, when fluidly connected
to a source of pressurized fluid, as a CHFO therapy device. In yet
other embodiments, the base construction can be employed with an
"active only" therapy device that provides CHFO therapy (and, in
some embodiments, other respiratory therapies such as CPAP) when
connected to a source of positive pressure fluid. With any of these
embodiments, optional features can be included to facilitate
delivery of aerosolized medication.
[0048] With the above understanding in mind, FIG. 1 is a block
diagram illustrating features of a respiratory therapy device 30 in
accordance with some aspects of the present disclosure. In general
terms, the respiratory therapy device 30 is adapted to operate in a
passive mode (e.g., oscillatory PEP) and an active mode (e.g., CHFO
and optionally CPAP), and generally includes a housing 32 and an
interrupter valve assembly 34. The housing 32 forms or maintains a
patient inlet 36, at least one chamber 38, an exhaust outlet 40,
and at least one pressurized fluid supply inlet 42. The interrupter
valve assembly 34 includes at least one control port 44 and a valve
body 46. The control port(s) 44 fluidly connects the patient inlet
36 and the chamber 38, whereas the valve body 46 is adapted to
selectively obstruct or interrupt fluid flow through the control
port(s) 44. Details on the various components are provided below.
In general terms, however, by controlling or operating the valve
body 46 to selectively obstruct (partially or completely) the
control port(s) 44, the interrupter valve assembly 34 alters
airflow/pressure characteristics to and/or from the patient inlet
36. For example, where the supply inlet 42 is not connected to a
separate source of pressurized fluid 48, as a patient (not shown)
exhales into the patient inlet 36, the interrupter valve assembly
34 operates to periodically at least partially close the control
port(s) 44, thereby establishing a resistance to airflow or back
pressure in the patient inlet 36. This periodic back pressure, in
turn, provides an oscillatory PEP therapy. In addition, when the
supply inlet 42 is fluidly connected to the pressurized fluid
source 48, the interrupter valve assembly 34 operates to
periodically at least partially interrupt fluid flow from the
supply inlet 42 to the patient inlet 36. This interrupted supply of
pressure toward the patient serves as a CHFO therapy. As described
below, the device 30 can optionally include features that
selectively disable all or a portion of the interrupter valve
assembly 34 in conjunction with the supply of pressurized fluid to
the supply inlet 42 in providing a CPAP therapy (either along or
simultaneous with CHFO therapy).
[0049] In light of the above, the respiratory therapy device 30
provides both active and passive modes of operation, allowing the
patient (not shown) to receive oscillatory PEP treatments with the
device 30 at virtually any location, as well as CHFO treatments
(and optionally other active treatments such as CPAP) when the
patient is at a location at which the pressurized fluid source 48
is available. The respiratory therapy device 30 can further be
configured to facilitate additional respiratory therapy treatments,
such as delivery of aerosolized medication (for example via a
nebulizer 50). The nebulizer 50 can be connected to a port (not
shown) provided by the housing 32, or can include an appropriate
connection piece (e.g., T-connector or line) that is fluidly
connected to the housing 32 (e.g., to the patient inlet 36) when
desired. Finally, while the pressurized fluid source 48 is shown
apart from the housing 32, in other embodiments, the pressurized
fluid source 48 can be attached to, or carried by, the housing 32
(e.g., a pressurized canister mounted to the housing 32).
[0050] With the above in mind, the respiratory therapy device 30
can assume a variety of forms capable of operating in a passive
mode (e.g., oscillatory PEP therapy) and an active mode (e.g., CHFO
therapy). One embodiment of a respiratory therapy device 60
providing these features is shown in FIG. 2. The therapy device 60
generally includes a housing 62 (referenced generally) and an
interrupter valve assembly 64 (referenced generally). The housing
62 includes a leading section 66, a trailing section 68, and an end
plate 69. The leading section 66 defines a patient inlet 70,
whereas the trailing section 68 defines a first chamber 72, a
second chamber (hidden in the view of FIG. 2), an exhaust outlet
(hidden in FIG. 2), and one or more supply inlets 74. The
interrupter valve assembly 64 includes a plate 76 forming one or
more control ports 78 (e.g., the control ports 78a, 78b), a valve
body 80, and a drive mechanism 82. Details on the various
components are provided below. In general terms, however, the drive
mechanism 82 is retained within the second chamber of the housing
62 and is assembled to the valve body 80 for causing rotation
thereof. The valve body 80, in turn, is located in close proximity
to the control ports 78 such that rotation of the valve body 80
selectively opens and closes (e.g., partial or complete
obstruction) the control ports 78 relative to the first chamber 72
and the patient inlet 70. Finally, the supply inlet(s) 74 are
fluidly connected to distribution points within the housing 62.
During use, and in a passive mode of operation, the therapy device
60 generates oscillatory PEP via operation of the drive mechanism
82 in response to the patient's exhaled breath. In addition, the
therapy device 60 provides an active mode of operation in which the
interrupter valve assembly 64 causes delivery of CHFO fluid flow to
the patient inlet 70 in acting upon positive fluid flow from the
supply inlet(s) 74. In this regard, a control means 84 (referenced
generally) can be provided that facilitates operation of the
therapy device 60 in a desired mode.
[0051] The housing 62 is shown in greater detail in FIGS. 3A and 3B
upon final assembly. The housing 62 is generally sized and shaped
for convenient handling by a patient, with the leading section 66
forming a mouthpiece 86 sized for placement in the patient's mouth
and through which the patient's respiratory cycle interacts with
the patient inlet 70. The mouthpiece 86 can be integrally formed
with one or more other component(s) of the housing 62, or can be
separately formed and subsequently assembled thereto.
[0052] The housing 62 can form or define fluid flow features in
addition to the supply inlets 74. For example, and as best shown in
FIG. 3A, the trailing section 68 forms a slot 90 as part of the
control assembly 84 (FIG. 2). As described below, the control
assembly 84 can assume a variety of forms, but in some embodiments
includes a body slidably disposed with the slot 90. With
alternative constructions, however, the slot 90 can be
eliminated.
[0053] Relative to the top perspective view of FIG. 3A, the housing
62 can further form first and second relief port arrangements 92,
94. A third relief port arrangement 96 can also be provided as
shown in the bottom view of FIG. 3B. Finally, as best shown in FIG.
2, a fourth relief port arrangement 98 is provided within an
interior of the housing 62. Operation of the therapy device 60 in
connection with the relief port arrangements 92-98 is described in
greater detail below. In general terms, however, the relief port
arrangements 92-98 each include one or more apertures 99, and are
adapted to maintain a valve structure (not shown), such as a
one-way umbrella valve, that permits fluid flow into or out of the
aperture(s) 99 of the corresponding port arrangement 92-98 in only
a single direction. As such, the relief port arrangements 92-98 can
assume a variety of configurations differing from those
illustrated. Similarly, additional relief port arrangements can be
provided, and in other embodiments one or more of the relief port
arrangements 92-98 can be eliminated.
[0054] Returning to FIG. 2, the supply inlets 74, otherwise carried
or formed by the housing 62, include, in some embodiments, first
and second patient supply inlets 74a, 74b, as well as a drive
supply inlet 74c. The patient supply inlets 74a, 74b are fluidly
connected to first and second nozzles 100a, 100b, respectively,
each positioned to direct fluid flow toward a corresponding one of
the control ports 78a, 78b (otherwise formed by the plate 76). A
relationship of the nozzles 100a, 100b and the control ports 78a,
78b relative to the internal features of the housing 62 is provided
below. It will be understood at the outset, however, that while two
of the control ports 78a, 78b are shown and described, in other
embodiments, one or three (or more) control ports are also
acceptable. Similarly, a nozzle/patient supply inlet need not be
provided for each of the control ports 78a, 78b (e.g., the patient
supply inlet 74b/nozzle 100b can be eliminated), or two or more
supply inlet/nozzles can be directed toward a single one of the
control ports 78. Even further, two or more supply inlets 74 can be
fluidly associated with a single nozzle 100.
[0055] With the above in mind, FIG. 4A is a longitudinal
cross-sectional view of the housing 62 upon final assembly taken
through the first patient supply inlet 74a. The leading portion 66,
the trailing portion 68 and the end plate 69 are generally
assembled to one another as shown. As a point of reference, the
view of FIG. 4A further illustrates the control means 84 in an open
position relative to the housing 62, and reflects that the plate 76
can be an integral component of the housing 62. Regardless, the
housing 62 is shown in FIG. 4A as defining the first chamber 72, as
well as a second chamber 101, and an exhaust chamber 102. The first
chamber 72 is defined, in part, by the plate 76 and an intermediate
wall 104, with the plate 76 fluidly separating the patient inlet 70
from the first chamber 72. In this regard, the patient inlet 70 is
fluidly connected to the first chamber 72 via the control ports 78
(it being understood that only the first control port 78a is
visible in FIG. 4A). The first chamber 72 is separated from the
second chamber 101 by the intermediate wall 104, with fluid
connection between the chambers 72, 101 being provided by a passage
106. As described in greater detail below, the passage 106 can be
fluidly closed via operation of the control means 84. Regardless,
the second chamber 101 is fluidly connected to the exhaust chamber
102 via an outlet opening 108. The first chamber 72 is also fluidly
connected to the exhaust chamber 102, via the fourth relief port
arrangement 98. As a point of reference, FIG. 4A reflects that a
one-way valve structure 110 is associated with the fourth relief
port 98 and is configured such that fluid flow can only occur from
the first chamber 72 to the exhaust chamber 102. Finally, the
exhaust chamber 102 terminates at an exhaust outlet 112 that is
otherwise open to ambient.
[0056] With the above conventions in mind, the first nozzle 100a is
positioned within the first chamber 72, and includes or defines an
inlet end 114 and an outlet end 116. The inlet end 114 is fluidly
connected to the first patient supply inlet 74a such that fluid
flow through the first patient supply inlet 74a is directed toward
the outlet end 116. The outlet end 116, in turn, is aligned with
the first control port 78a so as to direct fluid flow from the
first nozzle 100a to the first control port 78a. In some
embodiments, the first nozzle 100a tapers in diameter from the
inlet end 114 to the nozzle end 116, such that a jet-like fluid
flow from the first patient supply inlet 74a to the first control
port 78a is established. In this regard, ambient air can be
entrained into the fluid flow from the nozzle 100a (as well as the
nozzle 100b) via the second relief port arrangement 94. A one-way
valve structure 118 is illustrated in FIG. 4A as applied to the
relief port arrangement 94, and dictates that ambient air can only
enter the first chamber 72 (and thus the nozzle 100 fluid flow).
Though not shown, operation of the valve structure 118 can be
further controlled by a control mechanism that serves to
selectively maintain the valve structure 118 in a closed state
(e.g., during a passive mode of operation as described below). In
other embodiments, entrained ambient airflow within the first
chamber 72 can be provided in a different manner (e.g., not
including the relief port arrangement 94), or can be
eliminated.
[0057] Regardless of whether ambient air is introduced into the
first chamber 72, a gap 120 (referenced generally) is established
between the outlet end 116 and the plate 76 (and thus the first
control port 78a). As described in greater detail below, the gap
120 is sized to facilitate assembly and movement of the valve body
80 (FIG. 2). Though not shown, the second patient supply inlet
74b/second nozzle 100b (FIG. 2) has a similar construction and
relationship relative to the plate 76/second control port 78b.
Thus, and as best shown in FIG. 4B, the first patient supply inlet
74a/nozzle 100a directs positive pressure fluid from a separate
source toward the first control port 78a, and the second patient
supply inlet 74b/nozzle 100b directs positive pressure fluid toward
the second control port 78b.
[0058] The drive supply inlet 74c (FIG. 2) is similarly fluidly
connected to an interior of the housing 62. In particular, the
drive supply inlet 74c is fluidly connected to the second chamber
101 as shown in FIG. 4C. As described in greater detail below, a
portion of the drive mechanism 82 (FIG. 2) is retained within the
second chamber 101, with fluid flow from the drive supply inlet 74c
serving to actuate or drive the drive mechanism 82 during an active
mode of operation.
[0059] Returning to FIG. 2, the interrupter valve assembly 64 again
includes the valve body 80 that is driven by the drive mechanism
82. In some embodiments, the valve body 80 has a propeller-like
construction, and includes a base 130, a first valve plate segment
132, and a second valve plate segment 134. The base 130 is
configured for assembly to a corresponding portion of the drive
mechanism 82 as described below. The plate segments 132, 134 extend
in a radial fashion from the base 130, and each have a size and
shape commensurate with a size and shape of a corresponding one the
control ports 78a, 78b. For example, a size and/or shape of the
valve plate segments 132, 134 can be identical, slightly smaller or
slightly larger than a size and/or shape of the control ports 78a,
78b. Further, in some embodiments, a circumferential position of
the plate segments 132, 134 relative to the base 130 corresponds
with that of the control ports 78a, 78b such that when the base 130
is centrally positioned between the control ports 132, 134, the
control port 78a, 78b can be simultaneously obstructed by the plate
segments 132, 134. Thus, with the one embodiment of FIG. 2, the
control ports 78a, 78b are symmetrically opposed, and the valve
plate segments 132, 134 are similarly oriented. Alternatively, a
position of the valve plate segments 132, 134 can be spatially
offset relative to a position of the control ports 78a, 78b; with
this alternative construction, the control ports 78a, 78b are not
simultaneously obstructed during movement of the valve body 80.
[0060] While the valve body 80 is shown as including two of the
valve plate segments 132, 134, any other number, either greater or
lesser is also acceptable, and the number of plate segment(s) 132,
134 provided need not necessarily equal the number of control ports
78. In other embodiments, for example, the valve body 80 is
configured and positioned so as to fluidly interface with only one
of the control ports 78 as described below. Even further, the valve
body 80 can have configurations differing from the propeller-like
construction shown. Regardless, the valve body 80 is constructed
such that all of the control port(s) 78 can simultaneously be
obstructed (e.g., completely blocked or less than completely
blocked) by the valve body 80 in some embodiments.
[0061] The drive mechanism 82 is shown in greater detail in FIG.
5A. In some embodiments, the drive mechanism 82 is akin to a
reverse roots blower device and includes first and second lobe
assemblies 140, 142, and first and second gears 144, 146. The lobe
assemblies 140, 142 can be identical, with the first lobe assembly
140 including a lobe body 150 and a shaft 152. The lobe body 150
includes three longitudinal lobe projections 154, adjacent ones of
which are separated by a valley 156. Although three of the lobe
projections 154/valleys 156 are illustrated in FIG. 5A, any other
number is also acceptable; however, preferably at least two of the
lobe projections 154/valleys 156 are provided. Regardless, the
shaft 152 is, in some embodiments, coaxially mounted within the
lobe body 150, extending from a first end 158 to a second end 160.
The first end 158 is sized for assembly to the valve body base 130
(FIG. 2), whereas the second end 160 is sized for assembly to the
first gear 144. Other constructions are also contemplated such as
integrally molding or forming two or more of the lobe body 150,
shaft 154, and/or gear 140. The second lobe assembly 142 is
similarly constructed, and generally includes a lobe body 162
coaxially maintained by a shaft 164 that in turn is sized for
assembly to and/or formed as part of the second gear 146.
[0062] As shown in FIG. 5B, the lobe bodies 150, 162 are configured
for meshed engagement (e.g., one of the lobe projections 154 of the
second lobe body 162 nests within one of the valleys 156 of the
first lobe body 160), as are the first and second gears 144, 146
(it being understood that upon final assembly meshed engagement
between the lobe bodies 150, 162 and between the gears 144, 146 is
simultaneously achieved). With this construction, then, the lobe
assemblies 140, 142 rotate in tandem, but in opposite directions
(e.g., relative to the orientation of FIG. 5B, clockwise rotation
of the first lobe body 150 translates into counterclockwise
rotation of the second lobe body 162). The shafts 152, 164 are
affixed to the corresponding lobe body 150, 162, respectively, such
that rotation of the lobe bodies 150, 162 is translated directly to
the gears 144, 146, respectively, via the shafts 152, 164. Thus,
the gears 144, 146 serve to maintain a desired intermeshing
relationship between the lobe bodies 150, 162. With the reverse
roots blower configuration of the drive mechanism 82, a relatively
small force (e.g., fluid flow) is required to initiate and maintain
movement of the lobe assemblies 140, 142 at a desired rotational
speed. In other embodiments, the number of lobe projections 154 can
be increased so that the lobe bodies 150, 162 effectively interface
as gears such that the gears 144, 146 can be eliminated.
Regardless, upon final assembly, rotation of the first lobe
assembly 140 translates into rotation of the valve body 80.
[0063] Assembly of the interrupter valve assembly 64 to the housing
62 is partially shown in FIG. 6A. In particular, the valve body 80
is maintained immediately adjacent the nozzles 100a, 100b via the
shaft 152 that otherwise extends into the first chamber 72. The
shaft 164 of the second lobe assembly 142 (referenced generally in
FIG. 6A, shown in greater detail in FIG. 5A) also extends into, and
is supported at, the first chamber 72 (it being understood that the
opposite end of each of the shafts 152, 164 is also supported, for
example at or by the end plate 69 (FIG. 2)). As shown in FIG. 6B,
that otherwise is a longitudinal cross-sectional view taken through
the first patient supply inlet 74a, the first lobe body 150 is
maintained within the second chamber 101, as is the second lobe
body 162 (hidden in the view of FIG. 6B). The shaft 152 maintains
the valve body 80 such that the valve plate segments 132, 134 (it
being understood that the second plate segment 134 is hidden in the
view of FIG. 6B) are located in the gap 120 between the outlet end
116 of the first nozzle 100a and the plate 76 (as well as between
the second nozzle 100b, that is otherwise hidden in the view of
FIG. 6B, and the plate 76). With rotation of the valve body 80 (via
the drive mechanism 82), the valve plate segments 132, 134
repeatedly obstruct and "open" the control ports 78 relative to the
first chamber 72. In other words, the interrupter valve assembly 64
(referenced generally in FIG. 6B) operates to periodically stop or
substantially stop fluid flow between the patient inlet 68 and the
first chamber 72 as described below. While the valve body 80 has
been described as being assembled to the first shaft 152, in other
embodiments, the second shaft 164 rotates the valve body 80. In
other embodiments, each of the shafts 152, 164 can maintain a valve
body.
[0064] With the above understanding in mind, forced movement of the
drive mechanism 82 can occur in one of two manners that in turn are
a function of whether the device 60 is operating in a passive mode
(e.g., oscillatory PEP) or an active mode (e.g., CHFO). For
example, in the passive mode, the respiratory therapy device 60,
and in particular the drive mechanism 82, operates solely upon the
patient's exhaled air or breath. In this regard, and with reference
to FIGS. 2 and 6B, in the passive mode, the control means 84 is
positioned such that the passage 106 is open and fluidly connects
the first and second chambers 72, 101. In some embodiments, the
control means 84 includes a tab 166 slidably positioned within the
slot 90; in the "open" state of FIGS. 2 and 6B, the tab 166 is
retracted from the slot 90. The control means 84 can assume a wide
variety of other forms also capable of selectively opening or
closing the passage 106. The supply inlets 74a-74c are fluidly
closed or otherwise fluidly isolated from any external positive
pressure fluid source (e.g., the pressurized fluid source 48 of
FIG. 1 is disconnected from the respiratory therapy device 60;
fluid flow from the pressurized fluid source 48 is diverted from
the supply inlets 74a-74c; etc.). To this end, in some embodiments
the supply inlets 74a-74c can be exteriorly closed (for example, by
a cap assembly (not shown)).
[0065] With the therapy device 60 configured as described above,
the passive mode of operation can entail the mouthpiece 86 (or
other patient interface piece (not shown) otherwise attached to the
mouthpiece 86) is inserted into the patient's mouth, and the
patient being prompted to breathe through the therapy device 60.
During an inspiratory phase of the patient's breathing cycle,
ambient air is readily drawn into the housing 62 via the third
relief port arrangement 96 (that otherwise includes a one-way valve
structure 170 (FIG. 6B) controlling airflow therethrough). Thus,
the patient can easily and readily inhale air.
[0066] During the expiratory phase, exhaled airflow is directed
from the patient/mouthpiece 86, through the patient inlet 68, and
toward the plate 76. The exhaled air can fluidly pass or flow from
the patient inlet 68 to the first chamber 72 via the control ports
78 when the control ports 78 are otherwise not completely
obstructed by the valve body 80 (and in particular the valve plate
segments 132, 134). An example of this relationship is shown in
FIG. 7A whereby the valve body 80 has been rotated such that the
plate segments 132, 134 are "away" from the control port 78a (as
well as the control port 78b (hidden in the view of FIG. 7A)).
Thus, the exhaled air flows through the control ports 78 and into
the first chamber 72 (represented by arrows in FIG. 7A).
[0067] When the airflow into the first chamber 72 is at a pressure
below the opening pressure of a valve structure 172 associated with
the fourth relief port arrangement 98, the apertures 99 of the
relief port arrangement 98 remain fluidly closed, and all of the
airflow through the first chamber 72 flows into the second chamber
101 via the passage 106 (shown by arrows in FIG. 7A). Conversely,
where the pressure within the first chamber 72 is above the bypass
pressure associated with the valve structure 172, the valve
structure 172 "opens" to allow a portion of the airflow within the
first chamber 72 to flow into the exhaust chamber 102. In this
manner, the pressure drop across the second chamber 101 remains
approximately equal with the opening pressure associated with the
valve structure 172. Alternatively, other valving and/or flow
dimensions can also be employed
[0068] Airflow from the first chamber 72 into the second chamber
101 (via the passage 106) serves to drive the drive mechanism 82.
In particular, airflow within the second chamber 101 acts upon the
lobe assemblies 140, 142 (the lobe assembly 142 being hidden in
FIG. 7A), causing operation thereof as a rotary positive blower. In
general terms, and with additional reference to FIG. 5B, airflow
through the second chamber 101 causes the lobe bodies 150, 162 to
rotate, with airflow flowing through or between the lobe bodies
150, 162, and then to the outlet opening 108. In this regard, the
lobe assemblies 140, 142 operate as a roots blower, creating a
pressure drop across the second chamber 101. As shown in FIG. 7B,
when the control ports 78 are periodically "covered" by the valve
plate segments 132, 134, airflow through the control ports 78 is
restricted, creating a resistance to flow, or back pressure within
the patient inlet 68. This resistance to flow/back pressure occurs
periodically (i.e., when the valve plate segments 132, 134 are
rotated away from the control ports 78, back pressure within the
patient inlet 68 is released through the control ports 78). As a
result, a desired oscillatory PEP effect is created. Notably, the
lobe assemblies 140, 142 continue to rotate even as airflow through
the passage 106 is periodically interrupted due to inertia. Along
these same lines, the lobe assemblies 140, 142 can be configured to
act as a fly wheel, thereby reducing sensitivity to an opening time
of the control ports 78.
[0069] In some embodiments, dimensional characteristics of the
drive mechanism 82 are correlated with the valve body 80 and the
control port(s) 78 such that a flow rate of 10 lpm at 100 Pa, the
valve body 80 generates approximately 15 pulses per second at the
control ports 78, with the pressure pulses at approximately 3,000
Pa. At flow rates above 10 lpm, the valve structure 172 will open
and may flutter to maintain inlet pressure to the drive mechanism
82. The fourth relief port arrangement 98 can be configured set to
flow up to 20 lpm at 100 Pa (e.g., when the valve structure 172 is
"open") so as to keep the back pressure and speed approximately
consistent from 10 lpm to 30 lpm. Alternatively, however, the
therapy device 60 can be configured to exhibit other operational
characteristics.
[0070] With reference to FIGS. 2 and 8A, in the active mode of
operation, the control means 84 is operated to fluidly "close" the
passage 106 (e.g., the tab 166 is fully inserted into the slot 90).
Further, the inlets 74a-74c are fluidly connected to the
pressurized fluid source 48 (FIG. 1). For example, in some
embodiments, a flow diverter assembly (not shown) can be employed
to fluidly connect a single pressurized fluid source (e.g.,
positive pressure gas such as air, oxygen, etc.) to each of the
supply inlets 74a-74c; alternatively, two or more fluid sources can
be provided. Regardless, air, oxygen, or other gas is forced or
directed into the supply inlets 74a-74c. With specific reference to
FIG. 8A, fluid flow into the first patient supply inlet 74a is
illustrated with an arrow A and is directed by the nozzle 100a
toward the control port 78a. Ambient air is entrained into the flow
generated by the nozzle 100a via the second relief port arrangement
94 as previously described. In instances where the valve body 80,
and in particular the valve plate segments 132, 134, does not
otherwise obstruct the control port 78a (relative to the nozzle
100a), airflow continues through the control port 78a and into the
patient inlet 68. Though hidden in the view of FIG. 8A, a similar
relationship is established between the second patient supply inlet
74b/second nozzle 100b and the second control port 78a.
[0071] Conversely, and as shown in FIG. 8B, when the control port
78a and the control port 78b (hidden in FIG. 8B) are obstructed or
"closed" via the valve plate segments 132, 134, airflow from the
nozzles 100a, 100b to the patient inlet 68 is effectively stopped
(it being understood that in the view of FIG. 8B, only the first
patient supply inlet 74a/nozzle 100a, the first control port 78a,
and the first valve plate segment 132 are visible). Once again, the
drive mechanism 82 operates to continually rotate the valve body 80
relative to the control ports 78a, 78b, such that positive airflow
from the supply inlets 74 to the patient inlet 68 is "chopped" or
oscillated so as to establish a CHFO treatment during the patient's
breathing cycle (including at least the patient's inspiratory
phase).
[0072] To better ensure positive airflow toward the patient inlet
68 (and thus the patient), the control means 84 closes the passage
106 such that all air within the first chamber 72 is forced through
the control ports 78. In this regard, the drive mechanism 82, and
in particular the lobe assemblies 140, 142, are acted upon and
driven via fluid flow through the drive supply inlet 74c as shown
in FIG. 8C. In particular, forced fluid flow from the pressurized
fluid source 48 (FIG. 1) enters the second chamber 101 via the
drive supply inlet 74c and acts upon the lobe bodies 150, 162 as
previously described. In other words, operation of the therapy
device 60 in the active mode is independent of the patient's
breathing. Further, during the expiratory phase of the patient's
breathing cycle, pulsed gas flow from the nozzles 100a, 100b to the
patient inlet 70 continues, creating an oscillatory PEP effect. As
a point of reference, to minimize possible occurrences of stacked
breaths, exhaled air from the patient can be exhausted from the
patient inlet 70 via the first relief port arrangement 92. For
example, a one-way valve structure 174 can be assembled to the
relief port arrangement 92, operating (in the active mode) to
permit airflow through the relief port arrangement 92 to occur only
outwardly from the patient inlet 70, thus freely permitting
exhalation during periods when the control ports 78a, 78b are
blocked. An additional control mechanism (not shown) can further be
provided that fluidly "closes" the relief port arrangement 92/valve
structure 174 when the device 60 operates in the passive mode
described above (i.e., all exhaled air from the patient passes
through the control ports 78a, 78b). Alternatively, the device 60
can include other features (not shown) that facilitate exhausting
of exhaled air from the patient inlet 70, and/or the first relief
port arrangement 92 can be eliminated. Along these same lines, in
the active mode, the third relief port arrangement 96/valve
structure 170 can be permanently "closed" such that all inspiratory
airflow is provided via the control ports 78a, 78b.
[0073] While the device 60 has been described above as providing
CHFO therapy via essentially identical fluid flow from both of the
patient inlets 74a, 74b, in other embodiments, the device 60 can be
configured to provide a user with the ability to select or change
the level of CHFO. For example, a mechanism (not shown) can be
provided that causes fluid flow from one of the supply inlets 74a
or 74b to not occur (where a lower level of CHFO is desired) and
continuously "blocks" the corresponding control port 78a or 78b
(e.g., the supply inlet 74a or 74b can be fluidly uncoupled from
the pressure source, and a closure means (not shown) actuated
relative to the corresponding control port 78a or 78b). Even
further, the device 60 can be modified to incorporate three of the
supply inlets/nozzles 74/100 and three of the control ports 78,
with respective ones of the supply inlets/nozzles 74/100 being
selectively activated/deactivated and the corresponding control
ports 78 being selectively blocked so as to provide three levels of
CHFO. Alternatively, the three supply inlets 74 can merge into a
single nozzle 100, again allowing a user to select a desired CHFO
level by "activating" a desired number of the supply inlets 74.
[0074] In addition to the passive (e.g., oscillatory PEP) and
active (e.g., CHFO) modes described above, the therapy device 60
can further be configured to provide additional forms of
respiratory therapy. For example, and returning to FIG. 1, the
nebulizer 50 (FIG. 1) can be fluidly connected to (and optionally
disconnected from) the patient inlet 36 for providing aerosolized
medication and other treatment to the patient. With respect to the
exemplary therapy device 60 of FIG. 2, then, the housing 62 can
form or include an additional port (not shown) to which the
nebulizer 50 is fluidly connected. In some embodiments, the
nebulizer port is provided at or adjacent the mouthpiece 86 such
that nebulizer flow is directly to the patient and is not acted
upon by the interrupter valve assembly 64. Alternatively, the
nebulizer port can be formed at the end plate 69, or at any other
point along the housing between the end plate 69 and the mouthpiece
86. In other embodiments, one or more of the inlet ports 74a-74c
can serve as a nebulizer port. In yet other embodiments, the
nebulizer 50 can include a connection piece that is physically
attached to the mouthpiece 86. Regardless, nebulized air can be
provided during operation of the interrupter valve assembly 64 (in
either passive or active modes). Alternatively, the respiratory
therapy device 60 can be configured such that when in a nebulizer
mode of operation, the interrupter valve assembly 64 is temporarily
"locked" such that the valve body 80 does not rotate and the valve
plate segments 132, 134 do not obstruct the control ports 78.
[0075] Alternatively or in addition, the therapy device 60 can be
adapted to provide CPAP therapy (with or without simultaneous
aerosolized drug treatment) when desired by fluidly connecting the
pressurized fluid source 48 (FIG. 1) to one or both of the patient
supply inlets 74a, 74b, while again "locking" the interrupter valve
assembly 64. In particular, the interrupter valve assembly 64 is
held in a locked position whereby the valve body 80 does not
rotate, and the control ports 78a, 78b are not obstructed by the
valve plate segments 132, 134 such that positive airflow to the
patient occurs continuously. For example, and with reference to
FIGS. 5A and 8A, one or more mechanisms can be provided that, when
actuated, decouple the first drive shaft 152 from the first lobe
body 150 (so that the drive shaft 152 does not rotate with rotation
of the lobe body 150), and retains the valve body 80 in the "open"
position of FIG. 8A (e.g., magnet, body that captures one or both
of the valve plate segments 132, 134, etc.). Along these same
lines, the device 60 can be modified to deliver a constant,
baseline pressure CPAP therapy with or without simultaneous CHFO
treatment. For example, the interrupter valve assembly 64 can be
configured such that the valve body 80 only affects fluid flow from
the first supply inlet 74a, whereas fluid flow from second supply
inlet 74b is continuously supplied to the patient inlet 70. With
this approach, the second supply inlet 74b provides a specific,
baseline pressure (e.g., 5 cm water) as CPAP therapy, whereas the
interrupter valve assembly 64 acts upon fluid flow from the first
supply inlet 74a in creating a CHFO effect as described above. In
this regard, the interrupter valve assembly 64 can be "locked" as
described above during periods where CHFO therapy is not desired.
In yet another, related embodiment, the device 60 can be configured
to provide a varying, selectable level of CPAP. For example, a
mechanism (not shown) can be included that partially restricts (on
a continuous basis) the inlet end 114 (FIG. 4A) and/or the exit end
116 (FIG. 4A) of the nozzle(s) 100, or the corresponding supply
inlet 74, a desired extent (thus dictating a level of delivered
CPAP). Alternatively, a controlled leak can be introduced into the
system (e.g., a relief port arrangement and corresponding control
valve that exhausts to ambient can be provided at one or both of
the patient inlet 70 and/or the first chamber 72). Even further,
one or both of the patient inlets 74 can be selectively "activated"
to provide CPAP therapy as described above (it being understood
that the level of CPAP will be greater where fluid flow is provided
through both of the patient inlets 74 as compared to just one of
the patient inlets 74).
[0076] In yet other embodiments, the device can be configured to
optionally provide a continuous PEP therapy in the passive mode. In
particular, the interrupter valve assembly 64 is "locked" in an
open state as previously described, and the supply inlets 74 are
disconnected from the pressurized fluid source 48 (FIG. 1). As a
result, the control ports 78 serve as flow restrictors to exhaled
air, thus creating or delivering the PEP effect.
[0077] Regardless of whether the additional modes of operation are
provided, the therapy device 60 provides a marked advantage over
previous designs by being operable in both the passive and active
modes. For example, a patient can be given the therapy device 60
immediately following surgery, admission to the caregiver's
facility (e.g., hospital), etc., and instructed to use the therapy
device 60 in the passive mode. This allows the patient to begin
receiving oscillatory PEP therapy treatments immediately.
Subsequently, upon observation (x-rays, breath sounds, blood
analysis, etc.) by the caregiver that a more aggressive oscillatory
therapy is required to aide with airway clearance and/or airway
expansion, the therapy device 60 can then be connected to a
pressurized source (e.g., the pressurized fluid source 48 of FIG.
1) and switched to the active mode. Following the active treatment,
the therapist can leave the therapy device 60 with a patient to
allow the patient to continue the passive therapy without the
caregiver needing to be present. In other words, the patient can
continue to use the same therapy device 60 at virtually any
location away from the caregiver's facility.
[0078] Although the respiratory therapy device 60 has been
described as providing both passive and active modes of operation,
in other embodiments in accordance with the present disclosure,
similar principles of operation can be employed in a passive-only
or oscillatory PEP device (that otherwise interacts with the
patient's breathing). For example, an alternative embodiment
respiratory therapy device 186 is shown in exploded form in FIG. 9.
The therapy device 186 is similar in many respects to the
respiratory therapy device 60 (FIG. 2) previously described, and
includes a housing 188 (referenced generally) and an interrupter
valve assembly 190. The housing 188 includes a leading section 192,
an intermediate plate 194, a trailing section 196, and an end plate
198. The interrupter valve assembly 190 includes one or more
control ports 200a, 200b, a valve body 202, and a drive mechanism
204. As described in greater detail below, the drive mechanism 204
rotates the valve body 202 in response to exhaled airflow from the
patient to periodically obstruct or close the control ports 200a,
200b.
[0079] The leading section 192 of the housing 188 includes a
tapered mouthpiece 208, and forms or defines a patient inlet 210,
whereas the trailing section 196 forms a first chamber 212. The
plate 194 separates the patient inlet 210 and the first chamber
212, and forms the one or more control ports 200a, 200b. As with
previous embodiments, while two of the control ports 200a, 200b are
shown, any other number, either lesser or greater, is also
acceptable. Regardless, fluid flow between the patient inlet 210
and the first chamber 212 is via the control port(s) 200a,
200b.
[0080] The trailing section 196 further forms a second chamber 220
and, in some embodiments, an exhaust chamber (hidden in the view of
FIG. 9). The second chamber 220 is sized to receive a corresponding
portion of the drive mechanism 204 as described below, and is
fluidly isolated from the first chamber 212 by an intermediate wall
222. In this regard, and as best shown in FIG. 10, the intermediate
wall 222 forms a passage 224 through which fluid flow from the
first chamber 212 (FIG. 9) to the second chamber 220 (referenced
generally in FIG. 10) can occur. In addition, the intermediate wall
222 defines first and second holes 226a, 226b sized to receive
corresponding components of the drive mechanism 204 as described
below. Finally, and returning to FIG. 9, the end plate 198 is
adapted for assembly to the trailing section 196, and serves to
close the second chamber 220. As shown, the end plate 198 can form
grooves 228 sized to rotatably retain corresponding components of
the drive mechanism 204 as described below.
[0081] The valve body 202 is similar to the valve body 80 (FIG. 2)
previously described, and in some embodiments includes a base 230,
a first valve plate segment 232, and a second valve plate segment
234. The valve plate segments 232, 234 are shaped and sized in
accordance with the control ports 200a, 200b such that when
aligned, the valve plate segments 232, 234 can simultaneously
obstruct or "block" the control ports 200a, 200b. Regardless, the
valve plate segments 232, 234 extend radially from the base 230
that is otherwise configured for affixment to a corresponding
component of the drive mechanism 204.
[0082] The drive mechanism 204 is akin to a reverse roots blower
assembly, and includes first and second lobe assemblies 240, 242,
and first and second gears 244, 246. The lobe assemblies 240, 242
each include a lobe body 250a, 250b coaxially mounted to, or
integrally formed with, a shaft 252a, 252b, respectively. The
shafts 252a, 252b, in turn, are assembled to, or integrally formed
with, a respective one of the gears 244 or 246, with the valve body
202 being mounted to the shaft 252a of the first lobe assembly 240.
Upon final assembly, the lobe bodies 250a, 250b interface with one
another in a meshed fashion, as do the gears 244, 246.
[0083] With initial reference to FIG. 11, assembly of the
respiratory therapy device 186 includes placement of the lobe
bodies 250a, 250b/gears 244, 246 within the second chamber 220
defined by the housing 188. As shown, the shafts 252a, 252b extend
from the second chamber 220 and into the first chamber 212. The
valve body 202 is assembled to the shaft 252a of the first lobe
assembly 240 (or the shaft 252b of the second lobe assembly 242),
and is thus located with the first chamber 212. The intermediate
wall 222 serves to fluidly isolate the first and second chambers
212, 220, except at the passage 224.
[0084] The intermediate plate 194 and the leading section 192 are
then assembled to the trailing section 196 as shown in FIG. 12 (it
being understood that in some embodiments, the leading section 192
and the plate 194 can be integrally formed). In particular, upon
assembly of the leading section 192/plate 194, the valve body 202
is associated with the control port(s) 200a, 200b. For example, the
valve body 202 is positioned such that the valve plate segments
232, 234 selectively align with respective ones of the control
ports 200a, 200b with rotation of the valve body 202. FIG. 13A
illustrates the therapy device 186 upon final assembly.
[0085] A relationship of the various components of the therapy
device 186 are best shown in the cross-sectional view of FIG. 13B.
Once again, the patient inlet 210 is fluidly connected to the first
chamber 212 via the control ports 200a, 200b (it being understood
that only the first control port 200a is visible in FIG. 13B). The
valve body 202 is maintained in the first chamber 212 such that the
valve plate segments 232, 234 (it being understood that only the
first valve plate segment 232 is seen in the view of FIG. 13B) are
selectively aligned with the control ports 200a, 200b so as to
obstruct fluid flow between the patient inlet 210 and the first
chamber 212. The first chamber 212 is fluidly connected to the
second chamber 220 via the passage 224. The second chamber 220
maintains the lobe assemblies 240, 242 (it being understood that
only the first lobe assembly 240 is visible in the view of FIG.
13B). Further, the second chamber 220 is fluidly connected to an
exhaust chamber 254 via an outlet opening 256. The first chamber
212 is also fluidly connected to the exhaust chamber 254 via a
relief port arrangement 258 to which a valve assembly 260 (e.g., a
one-way, umbrella valve) is assembled. Finally, the exhaust chamber
254 is open to ambient at an exhaust outlet 262. As a point of
reference, the exhaust chamber 254 serves to minimize the
opportunity for one or both of the outlet opening 256 and/or the
relief port arrangement 258 to inadvertently be obstructed during
use. In other embodiments, however, the exhaust chamber 254 can be
eliminated.
[0086] During use, operation of the interrupter valve assembly 190
includes the lobe assemblies 240, 242 rotating in response to
airflow entering the second chamber 220 as described in greater
detail below. Rotation of the first lobe assembly 240 causes the
valve body 202 to similarly rotate, thus periodically moving the
valve plate segments 232, 234 into and out of alignment with
corresponding ones of the control ports 200a, 200b, creating an
oscillatory PEP effect in the patient inlet 210 as the patient
exhales.
[0087] For example, with reference to FIGS. 14A and 14B, the
mouthpiece 208 (or other component attached to the mouthpiece 208,
such as a nebulizer connector) is placed in the patient's mouth
(not shown) and the patient performs a breathing cycle through the
patient inlet 210. During the inspiratory phase, ambient air
readily enters the patient inlet 210 via a relief port arrangement
266, the flow through which is controlled by a one-way valve
structure 268 (such as an umbrella valve). During the expiratory
phase, exhaled air from the patient is directed through the patient
inlet 210 and toward the plate 194. With the valve body 202
arrangement relative to the control ports 200a, 200b of FIGS. 14A
and 14B, the valve plate segments 232, 234 are not aligned with the
control ports 200a, 200b such that the patient's exhaled air flows
from the patient inlet 210 through the control ports 200a, 200b,
and into the first chamber 212. This flow pattern is represented by
arrows in FIGS. 14A and 14B. Airflow within the first chamber 212
flows through the passage 224 and into the second chamber 220, and
then interacts with the lobe assemblies 240, 242. In particular,
airflow within the second chamber 220 causes the lobe assemblies
240, 242 to rotate, with the airflow then exiting the second
chamber 220 (at the outlet opening 256 of FIG. 14A) to the exhaust
chamber 254. Air within the exhaust chamber 254 is then exhausted
to the environment via the exhaust outlet 262.
[0088] As shown in FIGS. 14A and 14B, the valve structure 260
controls fluid flow through the relief port arrangement 258 between
the first chamber 212 and the exhaust chamber 254. In some
embodiments, the valve structure 260 is a one-way bypass valve
having a predetermined opening or bypass pressure. With this in
mind, so long as airflow within the first chamber 212 is below the
opening pressure of the valve structure 260, the valve structure
260 remains closed, such that all air flows into the second chamber
220 as described above. Where, however, pressure within the first
chamber 212 is above the opening pressure of the valve structure
260, the valve structure 260 will "open" and allow a portion of the
air within the first chamber 212 to bypass the second chamber
220/lobe assemblies 240, 242 and flow directly into the exhaust
chamber 254 via the relief port arrangement 258. In this manner,
the pressure drop across the second chamber 220 remains
approximately equal to the opening pressure of the valve structure
260.
[0089] With rotation of the lobe assemblies 240, 242 in response to
exhaled air entering the second chamber 220, the valve body 202 is
caused to rotate. To account for instances in which the valve body
202 is initially aligned with control ports 200a, 200b (and thus
may impede desired airflow into the second chamber 200 sufficient
to initiate rotation of the lobe assembles 240, 242), means (not
shown) can be provided by which a user can self-actuate movement of
the valve body 282, a valved conduit can be provided that directly
fluidly connects the patient inlet 210 with the second chamber 220,
etc. Regardless, the valve plate segments 232, 234 will
periodically be aligned with a respective one of the control ports
200a, 200b as shown, for example in FIGS. 15A and 15B. When
so-aligned, exhaled air from the patient at the patient inlet 210
is substantially prevented from passing through the control ports
200a, 200b. As a result, a back pressure is generated within the
patient inlet 210 that in turn is imparted upon the patient. This
airflow is represented by arrows in FIGS. 15A and 15B. Because the
valve body 202 is essentially continuously rotating in response to
exhaled air, this back pressure is created on a periodic or
oscillating basis. In other words, back pressure "pulses" are
established within the patient inlet 210, with the back pressure
being "released" from the patient inlet 210 as the valve plate
segments 232, 234 move away from the control ports 200a, 200b. In
some embodiments, the respiratory therapy device 186 is configured
such that at an exhaled airflow rate of 10 lpm at 100 Pa drives the
interrupter valve assembly 190 to create 15 pulses per second at
the control ports 200a, 200b, with the pressure pulses being at
approximately 3,000 Pa. At flow rates above 10 lpm, the valve
structure 260 will open and may flutter to maintain inlet pressure
to the drive mechanism 204. In related embodiments, the valve
structure 260 is configured to establish flow of up to 20 lpm at
100 Pa, which substantially maintains the desired back pressure in
the patient inlet 210 and a rotational speed constant in the range
of 10 lpm-30 lpm. Alternatively, however, the respiratory therapy
device 186 can be configured to exhibit a number of performance
characteristics differing from those described above.
[0090] Another embodiment respiratory therapy device 280 is shown
generally in FIG. 16, and is similar in construction to the device
60 (FIG. 2) previously described. In particular, the device 280
includes a housing 282 and an interrupter valve assembly 284. The
housing 282 is akin to the housing 62 (FIG. 2 previously
described), and generally defines a patient inlet 286, a first
chamber 288, a second chamber 290, and supply inlets 292 (one of
which is shown in FIG. 16). As compared to the housing 62, the
first and second chambers 288, 290 are permanently fluidly isolated
from one another (i.e., the notch 106 (FIG. 4A) is not provided).
The interrupter valve assembly 284 is akin to the interrupter valve
assembly 64 (FIG. 2), and includes control ports 294 (one of which
is shown) between the patient inlet 286 and the first chamber 288,
a valve body 296 and a drive mechanism 298.
[0091] In general terms, the device 280 operates as an
"active-only" configuration, whereby the ability to disconnect the
pressurized fluid source 48 (FIG. 1) from the supply inlets 292 and
perform a manual, passive oscillatory PEP therapy is not provided.
However, CHFO (and optionally CPAP) therapy is achieved as
previously described in a manner representing a marked improvement
over existing CHFO devices. For example, the device 280 can be
directly connected to virtually any pressurized fluid source and
still provide CHFO therapy (i.e., a separate "driver" unit is not
required as the device 280 itself modifies incoming, constant
pressure fluid flow into oscillatory flow to the patient).
Similarly, and unlike existing designs, the device 280 can be
modified as previously described with respect to the device 60
(FIG. 2) to provide additional modes of operation such as delivery
of aerosolized medication, CPAP, etc., separately or simultaneously
with CHFO treatment.
[0092] Yet another alternative embodiment respiratory therapy
device 300 in accordance with principles of the present disclosure
is shown in FIG. 17. The respiratory therapy device 300 includes a
housing 302 (referenced generally) and an interrupter valve
assembly 304. The housing 302 generally includes an outer housing
portion 306 and an inner housing portion 308 that combine to define
a first chamber 310 (referenced generally in FIG. 17 relative to
the outer housing portion 306) and a patient inlet 312. The
interrupter valve assembly 304 includes a valve body 314, a drive
mechanism 316 and a control port 318. Details on the various
components are provided below. In general terms, however, upon
final assembly, the valve body 314 is selectively associated with
the control port 318 (otherwise formed by the inner housing portion
308). The drive mechanism 316 selectively controls movement of the
valve body 314 toward and away from the control port 318, for
example in response to air exhaled by a patient during an
expiratory phase of a breathing cycle, so as to establish a
periodic back pressure within the patient inlet 312. This back
pressure, in turn, provides an oscillatory PEP therapy to the
patient.
[0093] The outer housing portion 306 is cylindrical and is sized to
receive and maintain the inner portion 308. With additional
reference to FIG. 18A, the outer housing portion 306 defines a
first end 320, a second end 322, and an intermediate section 324.
The first end 320 forms a passage 326 having a diameter or major
dimension commensurate with that of a corresponding segment of the
inner housing portion 308 such that upon assembly, the outer
portion 306 and the inner portion 308 are fluidly sealed at the
first end 320. Conversely, the second end 322 forms an opening 328
having a diameter or major dimension greater than a corresponding
dimension of the inner housing portion 308 (and any other
components attached thereto). With this configuration, the housing
302 is fluidly open to ambient at the second end 322. Finally, the
intermediate segment 324 similarly defines a diameter or major
dimension greater than that of the inner housing portion 308 so as
to define the first chamber 310 between the inner housing portion
308 and the intermediate segment 304 of the outer housing portion
306.
[0094] The inner housing portion 308 includes, in some embodiments,
a mouthpiece 330 and a tube 332. The mouthpiece 330 is adapted for
convenient placement within a patient's mouth (or assembly to
separate component (e.g., a nebulizer connection piece) that in
turn is adapted for placement on a patient's mouth. and thus can
have, in some embodiments, an oval-like shape as shown in FIG. 17.
Regardless, the mouthpiece 330 is connected to the tube 332, with
the components combining to define the patient inlet 312 in the
form of a continuous passage.
[0095] The tube 332 can assume a variety of different
constructions, and includes or defines a proximal section 334 and a
distal section 336. As shown in FIGS. 17 and 18A, the tube 332
includes an exterior shoulder 338 at the proximal section 334. As
described in greater detail below, the shoulder 338 serves as a
support or fulcrum for the drive mechanism 316 upon final assembly.
Regardless, the control port 318 is formed at or adjacent the
distal section 336, and establishes a fluid connection between the
patient inlet 312 and the chamber 310. While shown as being part of
the inner housing portion 308, then, the control port 318 is
effectively part of the interrupter valve assembly 304.
[0096] In addition to the control port 318, the interrupter valve
assembly 304 includes the valve body 314 and the drive mechanism
316 as shown in FIG. 18A. The valve body 314 is, in some
embodiments, a disc having a size and shape commensurate with a
size and shape of the control port 318 (e.g., the valve body 314
can have the same shape dimensions as the control port 318, or can
be larger or smaller than the control port 318). In some
embodiments, the valve body disc 314 is sized to be slightly larger
than the control port 318 to better achieve a more complete,
selective obstruction of the control port 318. As best shown in
FIG. 18B, the valve body disc 314 defines opposing first and second
major surfaces 340, 342. With the one embodiment of FIG. 18B, the
first surface 340 is flat. In other embodiments, however, the first
surface 340 can assume a different shape, such as a hemispherical,
conical, etc. Regardless, the first surface 340 is configured to
generally mate with an exterior surface 344 of the inner housing
portion 308 at which the control port 318 is defined.
[0097] Returning to FIG. 18A, the drive mechanism 316 is, in some
embodiments, akin to a beam or other cantilevered-type device, and
includes a leading end 350 and a trailing end 352. The leading end
350 is affixed to the valve body 314, whereas the trailing end 352
is adapted for assembly to the shoulder 338 of the inner housing
portion 308. As described below, the drive mechanism 316 serves as
a cantilever beam, and thus exhibits a desired stiffness for
repeated, cyclical deflection. With this in mind, in some
embodiments, the drive mechanism/beam 316 is formed of a steel
spring, although other materials are also acceptable.
[0098] Finally, and as shown in FIGS. 17-18B, in some embodiments
the respiratory therapy device 300 further includes a valve
assembly 354 mounted to the inner housing portion 308. The valve
assembly 354 can assume a variety of configurations, and can be
akin to a one-way valve (e.g., flap or umbrella check valve). Thus,
in some embodiments, the valve assembly 354 includes a frame 356
forming one or more apertures 358, along with a valve structure 360
that selectively obstructs the apertures 358. With this
configuration, the valve assembly 354 permits ambient airflow into
the tube 332/patient inlet 312, but restricts or prevents airflow
outwardly from the tube 332/patient inlet 312.
[0099] Assembly of the respiratory therapy device 300 includes
affixment of the valve assembly 354 to the distal section 336 of
the inner housing portion 308. The trailing end 352 of the drive
mechanism beam 316 is assembled (e.g., welded, bonded, etc.) to the
shoulder 338 of the inner housing portion 308. As shown in FIG.
18A, upon assembly, the drive mechanism beam 316 is substantially
straight and positions or aligns the valve body 314 with or "over"
the control port 318.
[0100] In the neutral or resting state of FIG. 18A, then, the valve
body 314 is in highly close proximity to the control port 318 so as
to overtly restrict fluid flow through the control port 318. In
some embodiments, and as best shown in FIG. 18B, the drive
mechanism 316 is configured such that with the drive mechanism beam
316 in the neutral or resting state, a slight gap 362 is
established between the valve body 314 and the exterior surface 344
of the inner housing portion 308 (otherwise defining the control
port 318). A size of the gap 362 dictates a level of pressure drop
within the patient inlet 312, with a dimension of the gap 362
having an inverse relationship to pressure drop within the patient
inlet 312. With this in mind, in some embodiments, the gap 362 is
less than 0.1 inch; and in other embodiments, less than 0.08 inch,
and in yet other embodiments, is less than 0.04 inch.
Alternatively, however, other dimensions are also acceptable,
including elimination of the gap 362. It has surprisingly been
found, for example, that where the control port 318 has a diameter
on the order of 0.28 inch, the valve body 314 is a disc having a
diameter on the order on 0.36 inch and a mass of 11.6 grams, where
the drive mechanism beam 316 is formed of stainless steel and has a
length on the order of 2.5 inches, a desired pressure drop/response
of the respiratory therapy device 300 at 20 lpm flow rate is
achieved with a dimension of the gap 362 being 0.011 inch. In
particular, the respiratory therapy device 300 exhibited, in some
embodiments, a pressure drop at 20 lpm flow rate in the range of
100-2,500 Pa.
[0101] During use, the therapy device 300 is provided to a patient
along with instructions on desired orientation during use. In this
regard, and in some embodiments, the therapy device 300 provides
optimal performance when the control port 318 is spatially
positioned at a "side" of the therapy device 300 as held by a
patient. The oval or oblong shape of the mouthpiece 330 provides
the patient with a visual clue of this desired orientation. While
the therapy device 300 can operate when spatially oriented such
that the control port 318 is facing "downwardly" (e.g., in the
orientation of FIGS. 18A and 18B), or "upwardly," an upright
orientation may better account for the effects of gravity during
operation of the interrupter valve assembly 304.
[0102] Notwithstanding the above, operation of the therapy device
300 is described with reference to FIGS. 19A and 19B with the
therapy device 300 in an otherwise "downward" orientation for ease
of illustration. It will be understood, however, that in other
embodiments, the therapy device 300 is preferably spatially held by
a patient such that the control port 318/valve body 314 is at a
"side" of the therapy device as held (i.e., into the page of FIGS.
19A and 19B). With this in mind, following insertion of the
mouthpiece 330 (or other component assembled to the mouthpiece 330)
into the patient's mouth, the patient performs multiple breathing
cycles. During the inspiratory phase, ambient airflow readily
enters the patient inlet 312 via the aperture 358/valve assembly
354. During the expiratory phase, exhaled air from the patient is
forced through the patient inlet 312 and toward the distal section
336 of the tube 332. The valve assembly 354 prevents exhaled air
from exiting the tube 332 via the apertures 358. Instead, the
exhaled airflow is directed to and through the control port 318;
airflow exiting the control port 318 exerts a force onto the valve
body 314 in a direction away from the tube 332 (and thus away from
the control port 318), as shown by arrows in FIG. 19A. The drive
mechanism beam 316 deflects to permit movement of the valve body
314 in response to the force, pivoting at the shoulder 338. As the
valve body 314 moves away from the control port 318, pressure drops
within the patient inlet 312, and the airflow proceeds to the
chamber 310 and then to ambient environment via the opening
328.
[0103] The drive mechanism beam 316 is configured to deflect only a
limited extent in response to expected forces on the valve body 314
(i.e., expected airflow pressures at the control port 318 in
connection with an adult patient's expiratory phase of breathing),
and thus resists overt movement of the valve body 314 away from the
control port 318. In addition, as the valve body 314 is further
spaced from the control port 318, the force placed upon the valve
body 314 by airflow/pressure from the control port 318 inherently
decreases due to an increased area of the gap 362. At a point of
maximum deflection (FIG. 19A), a spring-like attribute of the drive
mechanism beam 316 subsequently forces the valve body 314 back
toward the control port 318, such that the valve body 314 again
more overtly obstructs airflow through the control port 318. The
drive mechanism beam 316 ultimately returns to the near-neutral
position of FIG. 19B in which the valve body 314 substantially
closes the control port 318, and a back pressure is again
established within the patient inlet 312. The attendant force on
the valve body 314 then increases, causing the drive mechanism beam
316 to again deflect as described above. This cyclical movement of
the interrupter valve assembly 304 continues throughout the
expiratory phase, thereby creating a periodically-occurring back
pressure within the patient inlet 312. The patient, in turn,
experiences an oscillatory PEP treatment, with the patient's
exhaled air serving as the sole input force to the driving
mechanism beam 316.
[0104] Although the respiratory therapy device 300 has been
described in connection with a cantilever-type resonator
interrupter valve assembly 304, in other embodiments, a differing
configuration can be employed. For example, FIG. 20 schematically
illustrates an alternative embodiment interrupter valve assembly
370 in connection with a tube 372 otherwise forming a patient inlet
373 and a control port 374. As a point of reference, the tube 372
of FIG. 20 is akin to the tube 332 of FIG. 18A. Regardless, the
interrupter valve assembly 370 employs a rocker-type arrangement,
and includes a valve body 376 and a drive mechanism 378. The valve
body 376 is sized in accordance with a size of the control port 374
(e.g., identical, slightly smaller, or slightly larger), and is
maintained or driven by the drive mechanism 378. In this regard,
the drive mechanism 378 includes an arm 380, a support 382, and a
biasing device 384.
[0105] The arm 380 maintains the valve body 376 and is pivotally
mounted to the support 382 at a pivot point 386. The arm 380
includes a first side 388 at which the valve body 376 is formed or
affixed, and an opposite, second side 390. As shown, the second
side 390 is configured to provide additional mass to offset a mass
of the valve body 376. Regardless, the support 382 pivotally
maintains the arm 380 and can be assembled to, or formed as part
of, the tube 372.
[0106] The biasing device 384 exerts a biasing force onto the valve
body 376 opposite the control port 374. In some embodiments, the
biasing device 384 is a coil spring secured at a first end 392 to
the valve body 376/arm 380 and at an opposite, second end 394 to a
support structure 396 (drawn generally in FIG. 20). As a point of
reference, in some embodiments, the support structure 396 can be
formed by, or provided as part of, the outer housing portion 306
(FIG. 18A).
[0107] Regardless of exact construction, the interrupter valve
assembly 370 provides a balanced rocker arrangement, with the
biasing device 384 serving as a stiffness element. During use, the
valve body 376 limits airflow from the patient inlet 373/control
port 374, with the distance or gap between the valve body 376 and
the control port 374 (and thus the resistance to expiratory
airflow) being cyclically dictated by the biasing device 384. Once
again, as the valve body 376 approaches the control port 374, a
back pressure is created within patient inlet 373 (in conjunction
with continued airflow from the patient during the expiratory phase
of breathing). With this arrangement, then, an oscillatory PEP
therapy can be delivered, with the interrupter valve assembly 370
operating independent of a spatial orientation of the corresponding
respiratory therapy device/housing. Though not shown, an additional
nebulizer port(s) can be provided with, or formed by, the housing
302 through which aerosolized medication can be delivered to the
patient.
[0108] Yet another alternative embodiment interrupter valve
assembly 400 is shown schematically in FIGS. 21A and 21B. As best
shown in FIG. 21B, the interrupter valve assembly 400 is associated
with a tube 402 that is akin to the tube 332 (FIG. 18A) previously
described, and otherwise defines a patient inlet 404 and a control
port 406.
[0109] With the above conventions in mind, the interrupter valve
assembly 400 includes the control port 406, a valve body 408, and a
drive mechanism 410. Once again, the valve body 408 is sized and
shaped in accordance with the size and shape of the control port
406, as previously described (e.g., identical, slightly larger,
slightly smaller, etc.). With the embodiment of FIGS. 21A and 21B,
the drive mechanism 410 is akin to a proportional spring mass
system and includes a fly wheel 412 and a biasing device 414. The
fly wheel 412 is rotatably mounted relative to the tube 402, for
example by a spindle 416. As shown in FIG. 21A, for example, the
spindle 416 can be mounted or held by various surfaces 418a, 418b
provided with a housing (not shown) of the corresponding therapy
device. Regardless, the fly wheel 412 can freely rotate.
[0110] The biasing device 414 defines a first end 420 and a second
end 422. The first end 420 is secured to the valve body 408,
whereas the second end 422 is secured to the fly wheel 412, for
example by a finger 424 as shown in FIG. 21A. In some embodiments,
the biasing device 414 is a linear spring, but in other embodiments
can take other forms, such as a coiled torsional spring.
[0111] Regardless of exact construction, during use the valve body
408 serves to restrict airflow from the patient inlet 404 through
the control port 406. In this regard, a level of resistance to
airflow (and thus back pressure created within the patient inlet
404 during expiratory phase of a patient's breathing cycle) is a
function of a gap 426 (FIG. 21B) between the valve body 408 and the
control port 406. The drive mechanism 410, in turn, dictates a size
or dimension of this gap. In particular, as exhaled air is directed
through the control port 406, the valve body 408 is forced away
from the control port 406, with the biasing device 414 providing a
resistance to the airflow force placed upon the valve body 408.
Further, as the valve body 408 is moved away from the control port
406, the force is translated onto the biasing device 414, and then
onto the fly wheel 412. As a result, the fly wheel 412 slightly
rotates (e.g., counterclockwise relative to the orientation of FIG.
21B). At a certain point, a spring force of the biasing device 414
overcomes a force of the airflow through the control port 406, such
that the biasing device 414 forces the valve body 408 back toward
the control port 406. In this regard, the fly wheel 412 serves as a
guide for movement of the valve body 408, ensuring that the valve
body 408 moves back toward alignment with the control port 406. In
this manner then, a periodic back pressure is created within the
patient inlet 404, thus effectuating an oscillatory PEP therapy to
the patient during the patient's expiratory phase of breathing.
[0112] Although the respiratory therapy device 300 (FIG. 17), along
with the various interrupter valve assemblies 370 (FIG. 20), 400
(FIGS. 21A, 21B), has been described in the context of a
passive-only device (e.g., providing oscillatory PEP therapy in
response to the patient's exhaled breath), in other embodiments,
similar design configurations can be employed to provide a
respiratory therapy device capable of operating in both a passive
mode (e.g., oscillatory PEP) and an active mode (e.g., CHFO). For
example, FIG. 22 illustrates another alternative embodiment
respiratory therapy device 440 in accordance with aspects of the
present invention. The respiratory therapy device 440 is highly
similar to the respiratory therapy device 300 (FIG. 17) previously
described, and includes a housing 442 and an interrupter valve
assembly 444 including a first interrupter valve sub-assembly 446
and a second interrupter valve sub-assembly 448. Once again, the
housing 442 includes an outer portion 450 and an inner portion 452
that combine to define a chamber 454. The inner portion 452
includes a mouthpiece 456 and a tube 458 that combine to define a
patient inlet 460. Further, the tube 458 forms a first control port
462 fluidly connecting the patient inlet 460 and the chamber 454.
In this regard, the first interrupter valve sub-assembly 446 is
akin to the interrupter valve assembly 304 (FIG. 17) previously
described, and provides oscillatory back pressure within the
patient inlet 460 in response to exhaled air. In other words, the
first interrupter valve sub-assembly 446 operates as previously
described, establishing oscillatory PEP therapy.
[0113] In addition to the above, the housing 442 includes a supply
inlet 464 extending from the inner housing portion 452 and
exteriorly from the outer housing portion 450. The supply inlet 464
is configured for fluid connection to an external source of
pressurized fluid (not shown, but akin to the pressurized fluid
source 48 of FIG. 1), and is fluidly connected to a second control
port 466 formed by, or connected to, the tube 458.
[0114] With the above in mind, the second interrupter valve
sub-assembly 448 is akin to the first interrupter valve
sub-assembly 446 and includes the second control port 466, a valve
body 468 and a drive mechanism 470. The valve body 468 has a size
and shape commensurate with a size and shape of the second control
port 466, such that the valve body 468 can obstruct fluid flow
through the second control port 466. Though not shown, various
relief port arrangement(s) and related valve structure(s) can
further be included in connection with the second interrupter valve
sub-assembly 448 to ensure adequate pressure is reached to produce
desired pressure pulse/volume, and/or entrainment of ambient
air.
[0115] The drive mechanism 470 is, in some embodiments, an
elongated beam having a first end 472 and a second end 474. The
first end 472 maintains the valve body 468, whereas the second end
474 is configured for mounting to an interior shoulder 476 that in
some embodiments is formed or provided by the tube 458.
[0116] Upon final assembly, then, the valve body 468/drive
mechanism 470 are interiorly positioned within the tube 458, with
the valve body 468 being aligned with the second control port 466.
During use, positive airflow is established within the patient
inlet 460, with the fluid flow being directed to the second control
port 466. The second interrupter valve sub-assembly 448 operates to
periodically interrupt fluid flow through the second control port
466 and into the patient inlet 460. In particular, and as
previously described, the drive mechanism beam 470 moves the valve
body 468 in a cyclical fashion relative to the second control port
466, thereby creating a varying obstruction to fluid flow into the
patient inlet 460. Thus, when operating in an active mode (i.e.,
when the therapy device 440 is connected to the source of
pressurized fluid 48 of FIG. 1), the respiratory therapy device 440
provides CHFO treatment to the patient during the patient's
breathing cycle (including the inspiratory phase). Conversely, the
therapy device 440 can be disconnected from the source of
pressurized fluid (and the supply inlet 464 fluidly closed) and
operate in the passive mode to provide oscillatory PEP therapy.
Though not shown, the therapy device 440 can incorporate additional
features that facilitate use of the therapy device 440 to deliver
aerosolized medication, CPAP therapy (constant or variable), etc.,
as described above with respect to the device 60 (FIG. 2). Even
further, the therapy device 440 can be modified to serve as an
"active-only" device, for example by eliminating the first
interrupter valve sub-assembly 446.
[0117] Yet another alternative embodiment respiratory therapy
device 500 is shown in FIGS. 23A and 23B. The respiratory therapy
device 500 includes a housing 502 (referenced generally) and an
interrupter valve assembly 504 (referenced generally). Details on
the various components are provided below. In general terms,
however, the housing 502 maintains the interrupter valve assembly
504, and forms a patient inlet 506 fluidly connected to a chamber
508 via a control port 510. The interrupter valve assembly 504
includes a valve body 512 and a drive mechanism 514 (referenced
generally). During use, the drive mechanism 514 moves the valve
body 512 relative to the control port 510 such that the valve body
512 variably restricts airflow through the control port 510. In
this way, a pulsed back pressure is created within the patient
inlet 506, thereby delivering an oscillatory PEP therapy.
[0118] The housing 502 includes an outer portion 520, an inner
portion 522, and an orifice body 524. The outer portion 520
provides an exterior frame contoured for convenient handling of the
therapy device 500 by a user, and maintains the various components
thereof.
[0119] The inner housing portion 522 includes a mouthpiece 526 and
a tube 528. The mouthpiece 526 is sized and shaped for convenient
placement within a patient's mouth (or assembly to a separate
component adapted for placement in a patient's mouth, such as a
nebulizer connector piece), and can be integrally formed with the
tube 528. Regardless, the mouthpiece 526 and the tube 528 combine
to define the patient inlet 506 through which airflow to and from
the patient directly occurs. In this regard, the tube 528 extends
from the mouthpiece 526 to a trailing side 530.
[0120] With additional reference to FIG. 24, the orifice body 524
is assembled to, or formed as part of the tube 528 at the trailing
side 530 thereof. The orifice body 524 includes a rim 532 and a
wall 534. As best shown in FIG. 24, the control port 510 is formed
in the wall 534. In addition, the wall 534 forms a relief port
arrangement 536, consisting of one or more apertures 538. The
relief port arrangement 536 maintains a valve structure 540 that
otherwise allows airflow through the apertures 538 in only a single
direction. Regardless, the rim 532 forms a slot 542 that is
adjacent the control port 510. With this configuration, a body
inserted through the slot 542 can selectively obstruct all or a
portion of the control port 510.
[0121] Returning to FIGS. 23A and 23B, the valve body 512 is sized
for slidable insertion within the slot 542 and includes a leading
segment 544 and a trailing segment 546. The leading segment 544 is
sized for slidable placement within the slot 542, and in some
embodiments has a tapered shape. Regardless, the trailing segment
546 is configured for attachment to corresponding components of the
drive mechanism 514 as described below.
[0122] With the embodiment of FIGS. 23A and 23B, the drive
mechanism 514 is configured to operate as an EMF resonator and
includes a resonator system 548 (comprised of a beam 550 and a
micromotor assembly 552), control circuitry 554, an actuator 556,
and a power source 558. In general terms, the power source 558
powers the micromotor assembly 552. In response to a user prompt at
the actuator 556, the circuitry 554 activates the micromotor 552
that in turn causes the beam 550 to resonate, in some embodiments
at a natural frequency of the beam. Regardless, the beam 550
vibrates, causing the attached valve body 512 to move relative to
the control port 510.
[0123] The beam 550 is relatively thin and is formed from a stiff
material. In some embodiments, the beam 550 is formed of steel that
otherwise exhibits low damping characteristics; alternatively,
other materials such as plastic, ceramic, etc., may also be
employed. For example, where the beam 550 is formed of steel, it
can have a thickness on the order of 0.01 inch. Where differing
materials are employed, a nominal thickness of the beam 550 may be
increased or decreased.
[0124] As described in greater detail below, during use, the beam
550 is subjected to a vibrational force, causing a leading portion
560 thereof to resonate (whereas a trailing portion 562 is held
stationary). With this in mind, in some embodiments, the beam 550
is constructed (e.g., in terms of material and dimensions) so as to
not only fit within a desired footprint of the housing outer
portion 520, but also to exhibit a natural frequency above a
desired level such that when the micromotor assembly 552 and the
valve body 512 are attached to the leading section 560, the
resultant natural frequency of the resonator system 548 will
approximate a desired natural frequency. For example, in some
embodiments, a desired natural frequency of the resonator system
548 (at the leading section 560 of the beam 550) is approximately
15 Hz. In the absence of a mass of the micromotor assembly 552 and
the valve body 512, then, the beam 550 exhibits, in some
embodiments, a natural frequency well above 15 Hz (for example, on
the order of 40-80 Hz). With a mass of the valve body 512 and the
micromotor assembly 552 in mind, then, additional mass can be added
to the beam 550 to "fine tune" the overall natural frequency of the
resonator system 548 to approximate 15 Hz. Of course, in other
embodiments, other frequencies exhibited by the beam 550 alone
and/or in combination with the micromotor assembly 552 and the
valve body 512 are also acceptable.
[0125] As best shown in FIG. 23A, the micromotor assembly 552
includes a variable speed micromotor 570 that rotates an output
shaft 572. An unbalanced mass 574 is mounted to the output shaft
572. With this configuration, then, operation of the micromotor
assembly 552 generates a vibrational force load at the running
frequency. The micromotor 570 can assume a wide variety of forms,
and in some embodiments micromotor is a brushed, direct current
(DC) motor, adapted to rotate the output shaft 572 at a rotational
speed proportional to the input voltage supplied to the micromotor
570. For example the micromotor 570 can be akin to a micromotor
used in cell phone application for generating a vibrational force,
for example a micromotor manufactured by Maduchi Motor Co. under
the trade designation Model RF-J2WA. Regardless, the micromotor 570
is electronically connected to the circuitry 554 that in turn
regulates voltage supply to the micromotor 570 from the power
source 558.
[0126] The control circuitry 554 is, in some embodiments, a control
chip or circuit board adapted to regulate the voltage applied to
the micromotor 570 and limit current to the micromotor 570 based on
displacement and frequency of the valve body 512/beam 550. In this
regard, the control circuitry 554 is adapted to monitor the beam
550, effectively viewing the beam 550 as a capacitor. With this
approach, a measurement of both displacement and frequency can be
made. More particularly, the frequency measurement can be used to
control the output voltage to the micromotor 570 and maintain a
desired speed, while the displacement measurement can be used to
shift the speed of the micromotor 570 to avoid hitting "hard" stops
on the beam 550. As a point of reference, if the beam 550 hits a
"hard" stop, the beam 550 will stop oscillating and will require
time to regain the correct valve opening and frequency. One
exemplary schematic configuration of the control circuitry 554 is
provided in FIG. 25. It will be understood, however, that this is
but one acceptable configuration.
[0127] Returning to FIGS. 23A and 23B, the actuator 556 is
configured to prompt the control circuitry 554 to initiate or stop
delivery of power to the micromotor 570. In this regard, the
actuator 556 can assume a variety of forms, and in some embodiments
is a button or similar body projecting from the housing outer
portion 520. Alternatively, the actuator 556 can assume a variety
of other forms, for example a membrane-based sensor, wireless
actuator, etc.
[0128] Finally, the power source 558 provides appropriate power to
the micromotor 570 and the control circuitry 554. In some
embodiments, the power source 558 is carried within a compartment
576 of the housing 502, and can assume any appropriate form (e.g.,
one or more batteries).
[0129] The respiratory therapy device 500 is shown in assembled
forms in FIGS. 26A and 26B. In particular, the valve body 512 is
assembled to the leading section 560 of the beam 550 such that the
leading segment 544 extends away from the beam 550. The micromotor
assembly 552 is mounted to the trailing segment 546 of the valve
body 512 as best shown in FIG. 26A. In this regard, while the
trailing segment 546 is adapted to receive the micromotor assembly
552, in other embodiments, the micromotor assembly 552 can be
mounted directly to the beam 550.
[0130] The orifice body 524 is coupled to the trailing side 530 of
the tube 528 such that the wall 534 extends across the tube 528. As
shown in FIG. 26A, the one-way valve structure 540 is assembled to
the relief port arrangement 536 so as to control fluid flow through
the apertures 538.
[0131] The beam 550 is then assembled to the housing 502 such that
the trailing section 562 is affixed relative to the housing 502,
and the valve body 512 slidably extends within the slot 542 of the
orifice body 524. As best shown in FIG. 26B, in a natural state of
the beam 550, the leading segment 544 of the valve body 512
partially obstructs the control port 510. Further, and as best
shown in FIG. 26A, a slight gap 582 (referenced generally) is
established between the valve body 512 and the wall 534 of the
orifice body 524 (and thus the control port 510).
[0132] The power source 558 is assembled to the housing 502 as
shown, and electrically connected to the control circuitry 554 and
the micromotor 570, for example via wiring (not shown). The control
circuitry 554, as well as the actuator 556, are similarly assembled
to the housing 502.
[0133] During use, the micromotor assembly 552 is operated to
resonate the beam 550, and thus the valve body 512. As indicated
above, in some embodiments, the resonator system 548 (i.e., the
beam 550, micromotor 552, and the valve body 512) is constructed to
exhibit a natural resonation frequency approximating a desired
frequency of movement of the valve body 512 relative to the control
port 510. By exciting the resonator system 548 (and thus the beam
550) at the selected natural frequency, the input force and
function can be smaller than the force required to deflect the beam
550 alone, thus resulting in reduced power requirements. Thus, as
the motor assembly 552 vibrates, the beam 550 resonates, causing
the valve body 512 to move back and forth (e.g., up and down
relative to the orientation of FIG. 26B) relative to the control
port 510. As such, with resonation of the beam 550, the valve body
512 selectively "opens" and obstructs the control port 510 in an
oscillating fashion.
[0134] Regardless of whether the micromotor 570 is powered, during
the inspiratory phase of a patient's breathing cycle, ambient air
readily enters the patient inlet 506 via the relief port
arrangement 536. During the expiratory phase (and with appropriate
activation of the drive mechanism 514 via the actuator 556), the
drive mechanism 514 causes the valve body 512 to open and close the
control port 510 in an oscillating fashion. For example, and with
reference to FIG. 27A, as the beam 550 resonates downwardly
(relative to the orientation of FIG. 27A), the valve body 512
essentially closes the control port 510 such that exhaled airflow
within the patient inlet 506 cannot flow through the control port
510. As a result, a back pressure is created within the patient
inlet 506. Conversely, and as shown in FIG. 27B, as the beam 550
resonates upwardly (relative to the orientation of FIG. 27B), the
valve body 512 is radially displaced from the control port 510,
such that airflow within the patient inlet 506 easily passes
through the control port 510 and into the chamber 508 (and thus is
exhausted to ambient). In this regard, the control circuitry 554
operates to regulate power supply to the motor assembly 570 so as
to consistently resonate the beam 550 at a desired frequency (e.g.,
15 Hz). Regardless, the periodic back pressure created within (and
release from) the patient inlet 506 during the expiratory phase of
the patient's breathing cycle effectuates an oscillatory PEP
treatment for the patient. In other embodiments, one or more
nebulizer port(s) (not shown) can be provided with, or formed by,
the housing 502 to facilitate delivery of aerosolized medication to
the patient. Similarly, a nebulizer connection piece (not shown)
can be fluidly connected in-line to the mouthpiece 526.
[0135] Although the respiratory therapy device 500 has been
described as operating or providing only a passive mode (e.g.,
oscillatory PEP), in other embodiments, similar design
characteristics can be employed in providing a therapy device
capable of operating in both a passive mode as well as an active
mode (e.g., CHFO). For example, FIG. 28 illustrates another
embodiment respiratory therapy device 600 that is highly similar to
the therapy device 500 (FIG. 22A) previously described. More
particularly, the respiratory therapy device 600 includes the
housing 502 and the interrupter valve assembly 504 components as
previously described, as well as a supply inlet 602. The supply
inlet 602 is adapted for fluid connection to an external source of
pressurized fluid (not shown, but akin to the pressurized fluid
source 48 of FIG. 1), and terminates at a nozzle end 604. As shown,
the nozzle end 604 directs fluid flow from the supply inlet 602
toward the control port 510. Further, a position of the nozzle end
604 relative to an exterior of the housing 502 allows for
entrainment of ambient air into the fluid flow from the nozzle end
604. Additional valving (not shown) can optionally be provided to
prevent occurrences of stacked breaths.
[0136] In a passive mode of operation (i.e., the supply inlet 602
is disconnected from the pressurized fluid source), the therapy
device 600 operates as previously described (e.g., during the
expiratory phase of the patient's breathing cycle, the drive
mechanism 514 resonates the valve body 512 relative to the control
port 510 so as to establish a periodic back pressure within the
patient inlet 506 in providing oscillatory PEP therapy). In an
active mode of operation, positive fluid flow is forced through the
supply inlet 602 and directed by the nozzle end 604 toward the
control port 510. In connection with this forced supply of airflow,
the drive mechanism 514 again causes the valve body 512 to resonate
relative to the control port 510, thus cyclically interrupting
fluid flow from the nozzle end 604 through the control port 510,
and thus into the patient inlet 506. Thus, in the active mode of
operation, the respiratory therapy device 600 operates to provide
CHFO treatment to the patient during an entirety of the breathing
cycle (including at least the inspiratory phase of breathing).
Though not shown, the therapy device 600 can incorporate additional
features that facilitate use thereof to delivery aerosolized
medication, CPAP therapy, etc., as described above with respect to
the device 60 (FIG. 2). Even further, the therapy device 600 can be
modified to serve as an "active-only" device, for example by
providing an exhaust valve arrangement between the mouthpiece 506
and the control port 510.
[0137] The respiratory therapy device of the present invention
provides a marked improvement over previous designs. In some
embodiments, a standalone respiratory therapy device is provided,
capable of operating in a passive mode and an active mode. In the
passive mode, the therapy device effectuates an oscillatory PEP
treatment to the patient, and with many embodiments does so solely
in response to the patient's exhaled breath. In the active mode of
operation, an external source of pressurized fluid is connected to
the device with the device independently affecting fluid flow from
the external source to provide CHFO treatment. Unlike existing
configurations, embodiments of the present disclosure providing an
active mode of operation can be connected to virtually any
pressurized fluid source (e.g., regulated or non-regulated wall
source, home compressor, oxygen tank, a mechanical/pneumatic flow
interrupter or "driver," standalone ventilator system, etc.). In
this regard, when connected to an existing flow interrupter/driver
that otherwise generates pressurized fluid in pulsed form, the
driver can provide the ability to "tailor" the actual therapy
delivered to a particular patient. In yet other embodiments, the
respiratory therapy device provides passive therapy (e.g.,
oscillatory PEP) in a manner not previously considered. In yet
other embodiments, an improved "active-only" therapy device is
provided. Further, with any of the embodiments, additional
therapies can be provided, such as CPAP and/or nebulizer
treatments.
[0138] Although the present invention has been described with
respect to preferred embodiments, workers skilled in the art will
recognize that changes can be made in form and detail without
departing from the spirit and scope of the present invention.
* * * * *