U.S. patent application number 13/040048 was filed with the patent office on 2011-11-17 for portable high frequency air pulse delivery device.
Invention is credited to BRYAN FINLAY, RUTH E. MARTIN, BART NOWAK, MICHAEL NUTTALL, JULIE THEURER, JOHN ZEHR.
Application Number | 20110282248 13/040048 |
Document ID | / |
Family ID | 44858824 |
Filed Date | 2011-11-17 |
United States Patent
Application |
20110282248 |
Kind Code |
A1 |
MARTIN; RUTH E. ; et
al. |
November 17, 2011 |
PORTABLE HIGH FREQUENCY AIR PULSE DELIVERY DEVICE
Abstract
A portable air pulse delivery device includes a housing and an
air compressor having a motor disposed in the housing. The motor is
operable at speeds between 1200 and 4800 rpm. The air compressor
includes an air inlet and an air outlet. An untethered power source
is disposed in the housing and is operably connected to the motor.
An intake filter is disposed in the housing and is in fluid
communication with the air inlet of the air compressor. An outlet
port is coupled to the air outlet of the air compressor and is in
communication with an exterior of the housing. A mouthpiece
includes an inlet coupled to the outlet port and an outlet having a
gas exit port. The air compressor is operative to produce an
average gas flow rate of between about 2-3 L/min at the gas exit
port at a pulsation frequency of between about 20 Hz to 80 Hz. A
method for delivering air pulses to a mouth of a user is also
provided.
Inventors: |
MARTIN; RUTH E.; (LONDON,
CA) ; THEURER; JULIE; (LONDON, CA) ; NUTTALL;
MICHAEL; (LONDON, CA) ; FINLAY; BRYAN;
(LONDON, CA) ; NOWAK; BART; (LONDON, CA) ;
ZEHR; JOHN; (LONDON, CA) |
Family ID: |
44858824 |
Appl. No.: |
13/040048 |
Filed: |
March 3, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61310590 |
Mar 4, 2010 |
|
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61311145 |
Mar 5, 2010 |
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61417041 |
Nov 24, 2010 |
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Current U.S.
Class: |
601/1 |
Current CPC
Class: |
A61M 2210/0625 20130101;
A61M 16/0488 20130101; A61M 25/02 20130101; A61M 2025/0206
20130101; A61J 7/0061 20130101; A61M 16/0666 20130101; A61H 23/04
20130101; A61H 21/00 20130101; A61M 16/049 20140204 |
Class at
Publication: |
601/1 |
International
Class: |
A61H 1/00 20060101
A61H001/00 |
Claims
1. A portable air pulse delivery device comprising: a housing; an
air compressor comprising a motor disposed in said housing, said
motor operable at speeds between 1200 and 4800 rpm, said air
compressor comprising an air inlet and an air outlet; an untethered
power source disposed in said housing and operably connected to
said motor; an intake filter disposed in said housing, said intake
filter in fluid communication with said air inlet of said air
compressor; an outlet port coupled to said air outlet of said air
compressor and communicating with an exterior of said housing; and
a mouthpiece comprising an inlet coupled to said outlet port and an
outlet comprising a gas exit port, wherein said air compressor is
operative to produce an average gas flow rate of between about 2-3
L/min at said gas exit port at a pulsation frequency of between
about 20 Hz to 80 Hz.
2. The portable air pulse delivery device of claim 1 wherein said
mouthpiece is releasably coupled to said outlet port.
3. The portable air pulse delivery device of claim 1 further
comprising a hands free support coupled to said housing.
4. The portable air pulse delivery device of claim 1 wherein said
housing has a volume of less than about 1000 cm.sup.3.
5. The portable air pulse delivery device of claim 1 wherein said
housing has a volume of less than about 600 cm.sup.3.
6. The portable air pulse delivery device of claim 1 wherein said
housing has a volume of less than about 200 cm.sup.3.
7. The portable air pulse delivery device of claim 1 further
comprising controller operably coupled to said motor so as to cycle
said motor on and off in a predetermined sequence of time
periods.
8. The portable air pulse delivery device of claim 1 wherein said
untethered power source comprises at least one 9V battery.
9. The portable air pulse delivery device of claim 1 wherein said
filter comprises a scented element.
10. The portable air pulse delivery device of claim 3, wherein said
hands free support is a lanyard.
11. The portable air pulse delivery device of claim 3, wherein said
hands free support is a hook and loop strap.
12. The portable air pulse delivery device of claim 1 further
comprising an output delivering a signal when said air compressor
is operative.
13. A method for delivering air pulses to a mouth of a user
comprising: providing an untethered portable air pulse delivery
device comprising a housing and a mouthpiece connected to said
housing, said mouthpiece having a gas exit port; inserting said
mouthpiece into the mouth of the user wherein said gas exit port is
disposed in the mouth of the user; actuating a power switch on said
housing; automatically turning a compressor motor located in said
housing on and off for a predetermined sequence of predetermined
time periods and actuating a pump with said compressor motor;
operating said motor at a speed of between 1200 and 4800 rpm when
turned on; and producing an average gas flow rate of air with said
pump between about 2-3 L/min at said gas exit port at a pulsation
frequency of between about 20 Hz to 80 Hz when said motor is turned
on.
14. The method of claim 13 wherein said compressor motor is
automatically turned off a final time after said predetermined
sequence without intervention by the user.
15. The method of claim 14 further comprising coupling said device
to the user such that said device is retained by the user
hands-free.
16. The method of claim 15 wherein said coupling said device to the
user comprises disposing said housing in a pocket of an article of
clothing.
17. The method of claim 16 wherein said coupling said device to the
user comprises disposing a lanyard connected to said housing about
a neck of the user.
18. The method of claim 13 wherein said producing said average gas
flow rate of air comprises producing air pulses at said gas exit
port at a pressure less than 2.25 mmHg.
19. The method of claim 13 further comprising filtering air
entering said pump driven by said compressor motor.
20. The method of claim 19 wherein said filtering said air
comprises adding a scent to said air with a scent element.
21. The method of claim 13 further comprising releasably connecting
said mouthpiece to said housing.
22. The method of claim 13 further comprising powering said
compressor motor with an untethered power source disposed in said
housing.
23. The method of claim 13 further comprising delivering an output
signal while operating said motor.
Description
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/310,590, filed Mar. 4, 2010 and entitled
Portable High Frequency Air Pulse Delivery Device, U.S. Provisional
Application No. 61/311,145, filed Mar. 5, 2010 and entitled Oral
Mouthpiece and Method for Use Thereof, and U.S. Provisional
Application No. 61/417,041, filed Nov. 24, 2010 and entitled Oral
Mouthpiece and Method for the Use Thereof, the entire disclosures
of which are hereby incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention relates generally to an air pulse
delivery device used to administer a stimulus to a human or animal
to elicit and/or facilitate a desired physiological response and in
particular, to a portable air pulse delivery device connected to a
mouthpiece for delivering a substance to a human or animal to
initiate, evoke and/or facilitate swallowing or other sensorimotor
behaviors, and a method for the use thereof.
BACKGROUND
[0003] Dysphagia is a condition in which a person has difficulty
swallowing, characterized by impaired transport of saliva, drink,
and food from mouth to stomach. Dysphagia results from disease, or
damage, to the neural and/or aerodigestive tract structures that
produce swallowing. Often, dysphagia presents in stroke patients,
patients with other acute neurological conditions, patients having
Parkinson's disease or other neurodegenerative diseases, cerebral
palsy or chronic obstructive pulmonary disease (COPD) and/or in
response to various cancer treatments, wherein the patient has
difficulty in, and/or experiences pain with, swallowing. Likewise,
other patients may exhibit various swallowing, speech, salivary
and/or oral sensory impairments. Dysphagia compounds these health
problems via resultant complications, most commonly aspiration
pneumonia secondary to entry of saliva or food into the lungs,
dehydration and malnutrition. As such, some deaths attributed to
stroke, may actually be caused by dysphagia and the resulting
complication of pneumonia. These complications may also lead to
extended hospital stays, emergency room visits, re-admissions,
long-term institutional care and need for expensive respiratory and
nutritional support.
[0004] In response, various techniques and treatments have been
developed to induce or stimulate swallowing, which can provide
various therapeutic benefits to the patient or user. For example,
various devices and methods for inducing swallowing in a patient
include delivering one or more gas pulses to a predetermined area
of the mouth and/or throat. Often, however, such devices are
incapable of producing a train of pulses at desired frequencies,
operate at relatively high pressures, require various inputs
related to pressure, duration and frequency and/or are not
portable. Other devices apply electrical stimulation to the neck
overlying the laryngeal muscles.
SUMMARY
[0005] The present invention is defined by the following claims,
and nothing in this section should be considered to be a limitation
on those claims.
[0006] In a first aspect, one embodiment of a portable air pulse
delivery device includes a housing and an air compressor having a
motor disposed in the housing. The motor is operable at speeds
between 1200 and 4800 rpm. The air compressor includes an air inlet
and an air outlet. An untethered power source is disposed in the
housing and is operably connected to the motor. An intake filter is
disposed in the housing and is in fluid communication with the air
inlet of the air compressor. An outlet port is coupled to the air
outlet of the air compressor and is in communication with an
exterior of the housing. A mouthpiece includes an inlet coupled to
the outlet port and an outlet having a gas exit port. The air
compressor is operative to produce an average gas flow rate of
between about 2-3 L/min at the gas exit port at a pulsation
frequency of between about 20 Hz to 80 Hz.
[0007] In another aspect, a method for delivering air pulses to a
mouth of a user includes providing an untethered portable air pulse
delivery device having a housing and a mouthpiece connected to the
housing and inserting the mouthpiece into the mouth of the user.
The method further includes actuating a power switch on the housing
and thereby automatically switching a compressor motor located in
the housing on and off for a predetermined sequence of
predetermined time periods. The motor is operated at a speed of
between 1200 and 4800 rpm when switched on and produces an average
gas flow rate of air of between about 2-3 L/min at a gas exit port
at a pulsation frequency of between about 20 Hz to 80 Hz.
[0008] The various aspects and embodiments provide significant
advantages relative to the prior known devices. In particular, the
delivery device is capable of producing a train of pulses at
frequencies of 20-80 Hz, which is in the range of optimal muscle
stimulation for inducing swallowing. At the same time, the device
provides air pulses at low pressure, which avoids various risks
associated with electrical stimulation, for example with patients
with implanted pacemakers and/or potential risks and damage
associated with high-pressure systems. The system has also been
optimized in one embodiment, such that it does not require any
input from the user. Rather, the user simply switches the device
on, with a predetermined sequence of air train pulses being
administered at a predetermined frequency, duration and pressure.
The system then automatically powers down without any input from
the user. In this way, the device is not susceptible to tampering
or misuse, and does not require excessive training or knowledge
about alternative inputs for duration, pressure or frequency. As
such, it is particularly well suited for use outside of the patient
care system, including for example use in the home, office or
everyday environments.
[0009] The system also has been designed to be truly portable, such
that various embodiments can fit in the pocket, e.g., shirt, of the
user and/or be secured around the neck of the user with a lanyard,
or secured to clothing articles with a clip or hook and loop (e.g.,
Velcro) fastener, e.g., on a strap, or be secured to other
structures such as a rail or hook. Due to the small size and
untethered power source, the user can undergo treatment while going
about their day-to-day activities, untethered and hands free.
[0010] The foregoing paragraphs have been provided by way of
general introduction, and are not intended to limit the scope of
the following claims. The various preferred embodiments, together
with further advantages, will be best understood by reference to
the following detailed description taken in conjunction with the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a front perspective view of one embodiment of a
portable air pulse delivery device.
[0012] FIG. 2 is a rear perspective view of the portable air pulse
delivery device shown in FIG. 1.
[0013] FIG. 3 is a rear perspective view of the portable air pulse
delivery device shown in FIG. 1 with the battery cover removed.
[0014] FIG. 4 is a front interior view of the portable air pulse
delivery device shown in FIG. 1.
[0015] FIG. 5 is an enlarged, partial view of the power switch take
along line 5 of FIG. 4.
[0016] FIG. 6 is an enlarged, partial interior view of the filter
housing shown in FIG. 4.
[0017] FIG. 7 is circuit diagram of the logic for the circuitry
used to control and supply power to the compressor motor used in
the embodiment of FIG. 1.
[0018] FIG. 8 is a plan view of one embodiment of a mouthpiece.
[0019] FIG. 9 is a front view of the mouthpiece of FIG. 8 applied
to a user.
[0020] FIG. 10 is a partial perspective view of one embodiment of a
mouthpiece disposed in the mouth of the user.
[0021] FIG. 11 is a front perspective view of another embodiment of
a portable air pulse delivery device.
[0022] FIG. 12 is a rear perspective view of the portable air pulse
delivery device shown in FIG. 11.
[0023] FIG. 13 is a perspective view of a carrier structure.
[0024] FIG. 14 is a front interior view of the portable air pulse
delivery device shown in FIG. 11 with the front cover removed.
[0025] FIG. 15 is a rear interior view of the portable air pulse
delivery device shown in FIG. 11 showing the printed circuit
board.
[0026] FIG. 16 is circuit diagram of the logic for the circuitry
used to control and supply power to the compressor motor of the
embodiment shown in FIG. 11.
[0027] FIG. 17 is an exploded perspective view of alternative
embodiment of a portable air pulse delivery device.
DETAILED DESCRIPTION OF THE DRAWINGS
[0028] The terms "top," "bottom," "upwardly" and "downwardly" are
intended to indicate directions when viewing the device from the
perspective of the user. The term "lateral," as used herein, means
situated on, directed toward or running from side-to-side, for
example and without limitation from one side of the user's mouth to
the other. It should be understood that the term "plurality," as
used herein, means two or more. The term "longitudinal," as used
herein means of or relating to length or the lengthwise direction.
The term "coupled" means connected to or engaged with whether
directly or indirectly, for example with an intervening member, and
does not require the engagement to be fixed or permanent, although
it may be fixed or permanent, and includes both mechanical and
electrical connection. It should be understood that the term
"substance" as used in this specification includes without
limitation a fluid, such as a gas, liquid or combination thereof
(including, without limitation, an aerosolized liquid), and/or a
powder, including, without limitation, particles entrained in any
fluid, or combinations thereof.
[0029] As disclosed herein, a method and apparatus are provided for
delivering or applying a train of air pulses to the mouth or neck
of the user, whether human or animal, for the purpose of (1)
initiating, evoking or facilitating swallowing, speech production,
salivation, or an oral or oropharyngeal sensorimotor behaviour in a
subject, (2) increasing lubrication of the oral cavity, oropharynx,
and pharynx in a subject, (3) decreasing oral or oropharyngeal or
pharyngeal discomfort in a subject, (4) contracting muscles of the
lips, mouth, buccal area, tongue, jaw, soft palate, pharynx,
larynx, any of which could result in muscle strengthening with
repeated use of the oral appliance; (5) moving the lips, mouth,
buccal area, tongue, jaw, soft palate, pharynx, larynx, including
elevation of the larynx, including pre-swallow oral transport
movements and pre-swallow chewing-like movements; and/or (6)
creating sensations from the oral cavity or oropharynx that include
somatic, thermal or gustatory sensations.
[0030] One embodiment of the portable air pulse delivery device
provides a means of delivering a sequence of distinct air-pulse
trains, or aerosol-pulse trains to the oral cavity, oropharynx, or
pharynx of a person, where a train is defined as a series of at
least one pulse. The individual air-pulse trains may vary in terms
of the following pulse parameters: pulse duration, pulse amplitude,
pulse frequency, and train duration. In one embodiment, the
air-pulse trains, individually and in the aggregate, are presented
within a predetermined sequence.
[0031] Referring to FIGS. 1-7, 11-15 and 17, portable air pulse
delivery devices 120, 220, 420 are shown. The term "portable" as
used herein means capable of being operated free of any tethered
power source, and capable of being transported by hand, free of any
carriage device such as a wheeled caddy. The term "hands-free"
refers to a device that can be coupled or secured to the body of
the user or adjacent support structure such that the device does
not need to be held or retained by the user.
[0032] Referring to FIGS. 1-4, 11-15 and 17, the delivery device
includes a housing 122, 222, 422 formed in one embodiment by front
and rear housing components 124, 126, 224, 226, 424, 426 that are
secured to each other, for example by snap fit, fasteners,
adhesives, tabs, and similar fastening components, alone or in
combination. The housing has a front 128, rear 130, top 132, bottom
134 and opposite side walls 136. Of course, it should be understood
that the housing can be configured in other shapes and forms, and
is not limited to the disclosed rectangular parallelpiped shape.
The housing is made of a durable material with a reasonable degree
of impact resistance, for example ABS. The housing is relatively
small, such that it may be disposed in the pocket 140, e.g., shirt
or pant, of a user, or otherwise supported by or on the user in a
hands-free configuration, for example by way of a lanyard 142 or
clip, as shown in FIG. 9. In various embodiments, the overall
volume of the housing may be less than about 1000 cm.sup.3, less
than about 600 cm.sup.3, or less than about 200 cm.sup.3. For
example, in one embodiment, shown in FIGS. 1-4, the housing has
dimensions of 146 mm.times.75 mm.times.46 mm, or a volume of about
500 cm.sup.3. In another embodiment, the housing has dimensions of
100 mm.times.35 mm.times.55 mm, or a volume of about 193 cm.sup.3.
In the embodiment shown in FIGS. 11-15, the housing has dimensions
of 135 mm.times.81 mm.times.46 mm, or a volume of about 503
cm.sup.3. In another embodiment, the housing has dimensions of 141
mm.times.80 mm.times.46 mm, and weighing about 350 g. Due to the
compact nature of the device, the mass of the entire device,
including the housing, and a compressor 160, controller 170, 270
and batteries 180, 280 disposed therein, may be less than about 600
g, preferably less than about 400 g, and in one embodiment as low
as 300 g.
[0033] In one embodiment as shown in FIG. 17, by incorporating a
brushless motor and eliminating the batteries, the housing has
dimensions of 70 mm.times.70 mm.times.45 mm, or a volume of about
221 cm.sup.3, and weighs about 215 g. Alternatively, using a motor
with brushes, which may reduce the cost of the device, the housing
has dimensions of 90 mm.times.90 mm.times.47 mm, and a weight of
about 285 g.
[0034] As shown in FIGS. 1, 12 and 17, an air intake port 144, 244,
444 is positioned in one of the side walls 136 or rear cover 226 of
the housing respectively. An air filter 146 is disposed in the
housing adjacent the intake port such that air entering the intake
port passes through the air filter. Preferably, the air filter is
capable of removing air-borne particles greater than 50 .mu.m. In
one embodiment, the air filter may be configured as a removable
module 145, as shown in FIG. 6, with the module received in a
socket forming a filter housing. Under normal operating conditions,
daily use of the air pulse delivery device may warrant yearly
replacement of the air filter. The air filter medium is preferably
made of a material satisfying USP Class VI requirements, including
for example and without limitation Sefar Medifab.RTM. monofilament
polyamide, Nylon 6-6. The filter may incorporate a scented element,
which adds a flavor to the air drawn through the filter. For the
incorporation of flavours (scents) into the air filter, a
low-melting point material is preferred so as to minimize
degradation of the flavouring elements, including for example a
low-density polyethylene. Beneficial scents may include lemon and
mint. Various long lasting (100 hours or more) food-grade (USP
Class VI) flavor impregnated polymers (e.g., PolyFlav.TM. material
available from Schulman, Inc.) can be configured as a perforated
plug element. In other embodiments, flavor coatings are provided on
the filter mesh, which is capable of creating the desired scent(s)
for shorter durations.
[0035] Referring to FIGS. 1-5, 11-15, a power button 148 and an air
outlet port 150 are positioned on the top of the housing. Of
course, it should be understood that the air intake port 144, air
outlet port 150 and power button 148 can be positioned anywhere on
the housing as deemed most suitable. The housing also includes a
loop 152 or opening, which can be connected to the lanyard 142. The
lanyard 142 may be disposed around a neck of the user such that
they can use the device hands-free. The device also can be
configured with a clip, which may releasably engage a belt of the
user, or other clothing elements such as pocket, edge, etc. The
lanyard and clip are referred to as a hands-free retention
component. Similarly, a hook and loop, or Velcro fastener, e.g., on
a strap, may be attached to the retainer attachment 152, and the
Velcro fastener strap may then be used for the hands-free support
of the device on the user (e.g., a belt), or a bed rail, chair arm
or other convenient rail, hook or nearby support structure.
[0036] Referring to FIGS. 2 and 3, a removable panel 154 is
releasably secured to and forms a portion of the rear of the
housing. For example, a resilient tab 155 may releasably engage the
housing. A power source 180 is disposed in a cavity behind the
panel. In one embodiment, the power source is configured as a pair
of 9V batteries. When installed, the batteries engage corresponding
pairs of battery contacts 182. It should be understood that a
single battery may suffice, and that the batteries can be
configured in different sizes, for example in a range of 12 to 24
V, and further may be disposable or rechargeable. A plurality of
pads 156, e.g., rubber, are disposed on the rear of the housing,
including the cover 154, so as to provide shock absorption as well
as provide the housing with an anti-slip interface to prevent
sliding along a surface.
[0037] Referring to the embodiment of FIGS. 11-16, fixed,
rechargeable batteries 280 may be incorporated and connected with
battery connectors 281. One suitable embodiment uses a pair of 9
Vdc NiMH rechargeable batteries. In this embodiment, a removable
panel providing access to the batteries may be eliminated. A
battery charger may also be used to power the system while it is
recharging the batteries, with the charger coupled to a DC input
283 as shown in FIGS. 11 and 17. The batteries may be removed or
retained in situ for recharging. Alternatively, the enclosed
compressor system and its control circuitry may be enclosed in a
smaller casing (without batteries) as shown in FIG. 17, and instead
powered by a 115 Vac-powered transformer that provides the
requisite dc voltage to drive the motor and control circuitry. As
shown in FIG. 17 a power button 148 and underlying switch 482 are
located on top of the device. Referring to FIGS. 11-16, an output
jack 281 provides a 1 Vdc signal that may be used for synchronizing
the period of air pulsations with complementary recordings from
swallowing transducers, throat microphones, and respiratory
transducers. Referring to FIGS. 13 and 14, a carrier structure 290
is disposed in and secured to the housing, for example with a
plurality of fasteners. The carrier structure 290 includes a plate
structure 300 that holds the batteries 280 in place, as well as
provides a mounting component, configured as a pair of lugs 306,
for the printed circuit board 270, and a mounting component 304
including a series or ports 292, 294, 296, 298 for the power button
148, battery power indicator 271, configured as an LED light,
signal output 281 and mouthpiece connector 150. The battery power
indicator 271 provides an indication when the rechargeable
batteries 270 are low on power. The mounting component 304 is flush
with and is received in an opening defined by end portions of the
front and rear covers as shown in FIG. 11.
[0038] Referring to FIGS. 4 and 14-15, the compressor 160 includes
a motor 162 and pump 164, which are disposed in the housing. The
compressor has an air inlet 166 to the pump. The air inlet 166 is
connected to and in fluid communication with the air intake filter,
for example with a conduit 168 (not shown in FIGS. 14 and 15). The
compressor further includes an air outlet 172 connected to and in
fluid communication with the outlet port 150, for example with a
conduit 174 (not shown in FIGS. 14 and 15). The interior conduits
168, 174 are USP Class VI (ISO 10993-1), and may be made for
example and without limitation from silicone rubber, PVC or
polyurethane. In one embodiment, these materials do not include any
DEHP plasticizers. The compressor 160 is configured to provide
time-controlled, low-pressure, air pulses at frequencies in the
range of 20 to 80 Hz. For example, the motor 162 may be operable to
run at speeds of between about 1,200 and about 4,800 rpm, which
correlates to the desired frequencies without the need for a gear
system. For example, in one embodiment, the motor is operated by
the controller at a speed of about 2,400 rpm when switched on.
[0039] The pump 164 is coupled to the motor 162. One suitable pump
is a diaphragm pump, which is configured with a diaphragm piston,
and which may have a suitable displacement of about 1 mL. One
exemplary pump is the Hargraves BTC diaphragm pump, available from
Hargraves Technology Corp., Mooresville, N.C. In such a pump, air
may be delivered without contacting any moving parts of the pump.
The parts of the pump in contact with the air may be made of Vetra
(liquid crystal polymer), while the diaphragm may be made of EPDM
(ethylene-propylene-diene-monomer). The pump may also be configured
as an electro-magnetically driven pump. The portions of the pump in
contact with the respired air are biocompatible and do not
introduce adverse scents into the air circulated therethrough.
[0040] The mouthpiece 2 is sized and configured such that an air
flow rate of about 2-3 L/min (measured at standard temperature and
pressure (STP)) is achieved. For example, when operating at 2,400
rpm (40 Hz pulsations), a pump 164 with a displacement of about 1
mL can provide an average 2.5 L/min flow rate in a 1 m long
mouthpiece tube having a 1.5 mm internal diameter. In such a
system, air exiting the mouthpiece has kinetic energy at ambient
pressure. Testing has shown that with an average flow rate of 2.5
L/min, the resultant kinetically produced pressure on a surface at
1-8 mm from the exit port of the mouthpiece is in the range of
1.5-2 mmHg. In various preferred embodiments, the pressure is less
than about 2.25 mmHg.
[0041] Referring to FIGS. 4, 5, 7, 15, 16 and 17, the controller
170, 270, 470 is disposed in the housing and is coupled to the
power source 180 and power switch 182. In one embodiment, the
controller is configured as a control circuit incorporated on a
circuit board. Referring to FIGS. 7 and 16, the control circuit is
arranged and configured to cycle the compressor motor 162 and pump
164 on and off in a predetermined sequence of time periods. It
should be understood that other arrangements of hardware and
software may also be suitable. For example, the controller may
include a processor running software. The device may be configured
with an input/output for the processor, such that the motor speed,
duration of the ON/OFF periods and overall time of operation can be
changed.
[0042] Preferably, the burst of pulsating air-pulses should not
substantially interfere with the normal cycle of breathing. For
example, a normal adult may breathe 15 times per minute with 3
seconds of inspiration. Therefore, in one embodiment, the
controller 170, 270 energizes the motor 162 for X seconds ON and Y
seconds OFF (X:Y). In one embodiment for rehabilitation of
dysphagic patients, the predetermined X:Y sequence is repeated for
a predetermined time period, e.g., 20 minutes, with the treatment
being repeated every day, for example three times.
[0043] The air pulse trains are delivered to the oropharynx via the
mouthpiece 2, which has an input end releasably connected to the
outlet port with a quick lock connector 18 (see e.g., FIGS. 8 and
9). In one embodiment, shown in FIG. 10, portions 38 of the
mouthpiece sit within the buccal cavity, between the teeth and
cheek. In this embodiment, there is no mouthpiece material between
the upper and lower teeth, such that the patient is able to
maintain his/her upper and lower teeth 114, 116 in occlusion. This
is preferable since kinematic studies of swallowing have shown that
the upper and lower teeth are positioned along the occlusal plane
during the pharyngeal stage of swallowing. The mouthpiece appears
to have a relatively small impact on the resting position of the
subject's mouth, tongue, oropharynx, and face. For example, the
tongue in rest position does not make contact with the mouthpiece.
Because the mouthpiece is thin, the subject is able to achieve
closure of the lips. The mouthpiece does not come in contact with
pooled saliva in the sublingual region or along the lingual
surfaces of the teeth. Being positioned within the upper or lower
buccal region, the mouthpiece potentially allows the patient to
ingest and swallow food and drink while the mouthpiece is in
place.
[0044] In one embodiment, shown in FIGS. 8 and 9, the mouthpiece 2
is configured as an oral cannula. The oral cannula may include a
pair of flexible tubes 4, 6 configured to be positioned on opposite
sides of the face of a user. Of course, it should be understood
that the oral cannula may include only a single tube disposed on
one side of the user's face. The oral cannula may also be
configured with two tubes, but with gas being delivered through
only one of the tubes in some desired treatment modalities. The
flexible tubes 4, 6 may be made of thermoformed tubing, which can
be formed into a particular shape and configuration, but which has
some flexibility and ability to conform to the face and mouth of
the user. In one suitable embodiment, the flexible tube is made of
polyurethane, polyethylene, PVC, other suitable and biocompatible
materials, and/or combinations thereof. The tubes may have a
1/8.sup.th inch outer diameter and a 1/16.sup.th inch inner
diameter forming a lumen. Of course, other size tubes may also be
suitable, and the cross-sectional shape may be circular, or
configured in other geometrical shapes. The tubes may be clear or
transparent, translucent, coloured or opaque, and/or various
combinations thereof, with the visual characteristics varying along
the length of the tube for example so as to provide one or more
windows. Each tube may also be formed with a plurality of lumens,
or channels, to allow for additional features such as light,
sensors, fluid delivery, etc., including for example and without
limitation the delivery of an aerosolized liquid. In such
embodiments, the lumens may run parallel to each other, and include
for example and without limitation a first inner lumen and a second
exterior lumen formed around the inner lumen, or alternatively two
or more lumens running side by side. Of course, the plurality may
include more than two lumens.
[0045] In one embodiment, a wire may run along a length of at least
a portion of the flexible tubing 4, 6. The wire provides further
shape memory to the flexible tubing. The wire may be co-extruded
with the tube, or may be connected to the tubing by molding,
welding, adhesives and the like, or combinations thereof. The
tubing may also be shaped by over-molding with another polymer, or
by molded, curved sections that are subsequently attached to the
straight portions of tubing.
[0046] Referring to FIGS. 8 and 9, the flexible tube 4, 6 may be
made of, impregnated with, or coated with a flavored material,
including without limitation fruit (e.g., lemon), menthol or mint
flavors, which may be pleasing to the user and which may facilitate
swallowing. The tube may also be made of, impregnated with, or
coated with, an antistatic material, or alternatively a conductive
material. Antistatic materials have a surface resistivity of
between about 10E10 ohm/sq and about 10E 12 ohm/sq. Static
dissipative materials have a surface resistivity of between about
10E6 ohm/sq. and about 10E12 ohm/sq. Conductive materials have a
surface resistivity of between about 10E1 ohm/sq and about 10E6
ohm/sq. Metals typically have a surface resistivity of between
about 10E-1 to about 10E-5 ohm/sq. Surface resistivity as set forth
herein is measured pursuant to ASTM test D257. The tubing may also
be made of, or coated with, an antibacterial material. For example,
silver impregnation may provide antibacterial properties.
[0047] Each flexible tube 4, 6 includes an inlet portion 10, which
is preferably elongated and may extend from the neck region to the
ear of the user. The inlet portion has an inlet end portion 12
connected to an adapter (e.g., Y adapter) 14, with the adapter
having a feed tube 16 connected to an opposite end thereof. A
slideable connector 20, configured in one embodiment as a sleeve,
is disposed over and slidably receives the inlet portions 10 of the
tubes. The connector 20 may be moved back and forth along a portion
of the lengths of the inlet portions 10 of the tubes so as to
lengthen the end portion 12, and thereby secure the tubes under the
chin of the user, or to shorten the end portion 12, and thereby
loosen the tubes for comfort or removal.
[0048] As explained above, the feed tube 16 is configured to
connect to the outlet port, which supplies air, for example and
without limitation by way of the quick connect 18 having a
releasable component, such as a detent. Various exemplary
mouthpieces and control systems are shown and disclosed in US Pub.
No. 2006/0282010A1, entitled Oral Device, and U.S. patent
application Ser. No. 12/424,191, filed Apr. 15, 2009 and entitled
Swallowing Air Pulse Therapy Mouthpiece and Methods for the Use
Thereof, the entire disclosures of which are hereby incorporated
herein by reference.
[0049] Referring to FIGS. 8 and 9, the pair of tubes 4, 6 are a
mirror image of each other, or can be folded one onto the other,
along a longitudinal axis 24. The various portions of the tubes may
be formed or positioned within a plane, although during use, the
tubes 4, 6 conform to the face 28 of the user and are self
supported on the face and in the mouth 30, meaning the user and/or
care giver are not required to hold or position the tubes with
their hands, lips, tongue, teeth and/or other devices.
[0050] The tubes 4, 6 each have a curved portion 32 forming an ear
loop connected to the inlet portion 10. In one embodiment, the ear
loop 32 may be encapsulated, or covered with a padding material 40,
such as foam, which provides greater comfort to the user. Of
course, it should be understood that other portions of the tube,
such as the portion 42 running along the face of the user, may also
be covered or secured to an interfacing material, such as a
padding, to improve comfort.
[0051] Another curved portion 34 forms a lip bend. The curved
portion 34 is connected to the curved portion 32 with an elongated
portion 42 that runs along the face or cheek of the user. The
curved portion 34 has a curvature that is less than the curvature
of the curved portion 32, meaning in this embodiment, the radius of
the curved portion 32 is greater than the radius of the second
curved portion 34. In one suitable embodiment, the curvature of the
curved portion 34 has an inner radius of about 0.25 inches. It
should be understood that the curvatures may be other than
semi-circular, such as quarter circular, and may for example be
curvilinear, or polygonal (i.e., formed from a plurality of
discrete linear segments). The term "curvature" refers to the tube
having a first portion defining a first vector and a second portion
defining a second vector, wherein the vectors are co-planar but not
the same (meaning they may have different angles or orientations
(e.g., parallel but directed in opposite directions)). It should be
understood that a curved portion may have multiple curvatures, for
example having a curvature in one plane and another curvature in
another plane. For example, the curved portion 34, or lip bend, has
a plurality of curvatures, including a first curvature in a plane,
and a second curvature of a portion thereof as the curved portion
34 transitions to an outlet portion 36 having a curvature in a
plane substantially perpendicular to the plane. It should be
understood that the curvatures may be formed in multiple planes not
perpendicular or parallel to each other. The curved portions 32, 34
open in opposite first and second directions 50, 52.
[0052] The outlet portion 42 extends from the curved portion 32 and
terminates in an end portion 38 having a gas exit port 54. The
outlet portion 42 has a curvature defined by first and second
vectors 44, 46 forming angles .beta. of 30.degree. relative to the
plane 26. In one embodiment, the length (L1) of the outlet portion
is about 1.6 inches (.+-.0.2 inches), or 1.760 inches (.+-.0.2
inches) from the inner surface of the curved portion 32 to the
terminal end of the end portion 38, with the end portion extending
below the first plane. The end portion 38 may also be formed as a
curved portion.
[0053] The outlet portion 36, as shown in FIG. 10, is curved such
that it extends into the user's mouth 30 and is disposed between
the side of a row of upper teeth 114 of the user (preferably above
the gum line) and the interior surface of the user's cheek. Of
course, it should be understood that the configuration and shape
can be altered to accommodate placement in a similar location along
the side of the lower teeth or even along the occlusal plane. The
end portion 38, or curved portion, may be directed laterally
inwardly at a targeted region of the rear of the user's mouth 30
and throat. The end portion is configured with the gas exit port
54. In this way, no portion of the tube is disposed between the
user's upper and lower teeth, or between the user's tongue and
palate (roof of the mouth). As such, the tube does not interfere
with normal speech, eating, drinking swallowing, etc., e.g.,
enabling the tongue to elevate and move a bolus rearwardly as it
contacts the palate, and the tube does not have to be held in place
over or between the user's teeth. In one embodiment, each of the
inlet portions, ear loop, lip bend and outlet portion may be
integrally formed from a single piece of tubing.
[0054] In operation, the user or care giver disposes a portion of
the mouthpiece, e.g., the flexible tube, and in particular the
outlet portions 38, 408, 410, between an outer side surface of a
row of teeth 114, 116 (upper or lower) and an inner surface of a
cheek. In one embodiment, tubes are disposed on opposite sides of
the mouth. The tubes are positioned such that the exit ports 54 are
positioned in a rear region of the mouth and wherein no portion of
the flexible tube is disposed between the upper and lower teeth of
the user such that the upper and lower teeth can be closed against
each other, or between the tongue and palate of the user, such that
the tongue is free to touch the palate. The ear loops 32 are
disposed around the ears 100 of the user, with the mouth/lip bend
being positioned around/over the lip 102 and the outlet portion of
the tube being positioned along the side of the teeth as just
described. The position of the connector 20 can then be adjusted to
further secure the cannula to the user. It should be understood
that the disclosed mouthpiece is exemplary, and that other
mouthpieces may also work with the air pulse delivery device.
[0055] In any of the embodiments, the mouthpiece feed tube 16 is
connected to the outlet port of the housing 122. To ensure that the
correctly sized tubing is utilized with the miniature compressor,
the connection between the mouthpiece and housing may be customized
so as to allow for mating of a particular configuration.
Alternatively, a radio frequency identification, or RFID tag, can
be employed to ensure a proper combination of mouthpiece and
portable pulsed air supply device, with the system only being
actuatable with the proper RFID. The system may alternatively
incorporate a memory chip and direct electrical connection.
[0056] Once the device is properly configured, and the mouthpiece 2
installed, the power button 148 is pushed, which moves the power
switch 182 to an ON position, with a green LED light being
illuminated and the controller 170 receiving an input. The LED
light may be disposed in the button 148, or at another location on
the housing. After about 1 second, the automated sequence of
air-pulsing is commenced, with pulsating air delivered to the rear
of the subject's mouth through the mouthpiece port 54. No
adjustments are required by the person being treated or the
caregiver to control the frequency, duration or pressure of the
pulsations. The air pulses will continue for 2-3 seconds (or some
other desired time period) before the compressor 160 stops. After a
second predetermined time period, e.g., 17 or 20 seconds or some
other desired and controlled time period, the compressor
recommences the air pulses for another predetermined time period,
e.g., 2-3 seconds. This predetermined X:Y sequence, e.g., 2-3
seconds ON and 17 or 20 seconds OFF, continues for a predetermined
time period, e.g., 20 minutes, unless manually switched off before
then. Further use of the device requires the unit to be switched
off and then switched on again. Alternatively, the device is
configured to automatically switch off, with the LED light no
longer displaying power indicia. Using a pair of two 9 V batteries
as the power source 180, the device is capable of providing twelve
20 minute treatments, or about 4 hours of operation. The device is
configured such that a red LED light 271 will illuminate when the
batteries require replacement or recharging.
[0057] In another embodiment, the delivery device 120 is connected
to an external applicator of pulses. In particular, a cup of about
18 mm inside diameter and 4 mm depth is held by hand or with a
strap against the neck 190 of the user. The cup is shaped and
configured to prevent the cup from being filled by the skin of the
user. The device is then operated to provide air pulses to the
outer skin of the neck, so as to evoke swallowing in the same
manner as that achieved by more complex electro-mechanical
systems.
[0058] Although the present invention has been described with
reference to preferred embodiments, those skilled in the art will
recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention. As such, it
is intended that the foregoing detailed description be regarded as
illustrative rather than limiting and that it is the appended
claims, including all equivalents thereof, which are intended to
define the scope of the invention.
* * * * *