U.S. patent application number 13/182994 was filed with the patent office on 2011-11-24 for systems and methods for nasal lavage.
This patent application is currently assigned to RhinoSystems, Inc.. Invention is credited to Gary R. Austin, Jess Paul Carlson, Martin R. Hoke, Robert D. Schilling.
Application Number | 20110288476 13/182994 |
Document ID | / |
Family ID | 42241401 |
Filed Date | 2011-11-24 |
United States Patent
Application |
20110288476 |
Kind Code |
A1 |
Hoke; Martin R. ; et
al. |
November 24, 2011 |
Systems and methods for nasal lavage
Abstract
A nasal lavage device includes a source of saline solution, an
effluent receptacle, and a nasal interface for engaging the
nostrils of a user of the device. A fluid passageway is disposed to
communicate the source of saline solution with the effluent
receptacle through the nasal cavity of the user. The nasal
interface and fluid passageways are included within a removable
cartridge for communicating the saline relative to the nostrils in
a first direction. A second cartridge can be inserted to
communicate the flow in a second direction. The interface includes
nasal pillows that form a seal against the user's nostrils.
Inventors: |
Hoke; Martin R.; (Lakewood,
OH) ; Schilling; Robert D.; (Olmsted Township,
OH) ; Austin; Gary R.; (Euclid, OH) ; Carlson;
Jess Paul; (Chagrin Falls, OH) |
Assignee: |
RhinoSystems, Inc.
|
Family ID: |
42241401 |
Appl. No.: |
13/182994 |
Filed: |
July 14, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12635253 |
Dec 10, 2009 |
7981077 |
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13182994 |
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61121643 |
Dec 11, 2008 |
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Current U.S.
Class: |
604/94.01 |
Current CPC
Class: |
A61M 3/0266 20130101;
A61M 1/0058 20130101; A61M 3/0258 20130101; A61M 2210/0618
20130101 |
Class at
Publication: |
604/94.01 |
International
Class: |
A61M 3/02 20060101
A61M003/02 |
Claims
1. A nasal pillow comprising: a flexible skirt depending from a
sleeve, wherein the sleeve and skirt are integrally formed for
sealing engagement against the nostrils of a user and the skirt is
spaced from the sleeve for flexible adjustment relative thereto
while engaging a nostril of a user.
2. The nasal pillow of claim 1 comprising an integrally formed
elastomeric material.
3. The nasal pillow of claim 1 wherein the skirt includes a taper
toward an opening of the pillow for a sealing disposal adjacent the
nostrils.
Description
[0001] This application claims the priority benefit, as a
continuation, of U.S. application Ser. No. 12/635,253, filed Dec.
10, 2009, which claims the priority of U.S. application Ser. No.
61/121,643, filed Dec. 11, 2009, the disclosures of which are
incorporated herein by reference in their entirety.
TECHNICAL FIELD
[0002] The presently disclosed embodiments generally relate to
methods and devices for lavaging, irrigating, rinsing, and
hydrating the nasal cavity and anatomical openings thereto,
generally and popularly known as nasal lavage or nasal
irrigation.
BACKGROUND
[0003] Nasal and sinus disease and sinus related syndromes and
symptoms are a common clinical problem with considerable patient
morbidity, substantial direct costs, and a significant, negative
impact on the quality of life for those who are afflicted. The four
primary categories of afflicted groups are: 1) individuals with
acute and chronic rhinosinusitis; 2) individuals with upper
respiratory infections, 3) individuals who suffer from allergic
rhinitis; and 4) individuals with chronic snoring problems. These
four categories amount to millions of people who suffer from nasal
congestion on a daily basis.
[0004] The Centers for Disease Control and Prevention estimated the
number of cases of chronic rhinosinusitis in the United States to
be 35 million in 1994, a prevalence of about 13.5%, or about 40.5
million Americans adjusted for 2007 population figures (estimates
from the National Health Interview Survey, 1994. Vital Health Stat
10. 1995:261-520). Rhinosinusitis was the fifth most common
diagnosis for which antibiotics were prescribed from 1985 to 1992
(McCaig L F, Hughes J M. Trends in antimicrobial drug prescribing
among office-based physicians in the United States. JAMA. 1995;
273:214-219). In 1996 rhinitis accounted for approximately 26.7
million office and emergency department visits resulting in $5.8
billion in direct costs (Ray N F, Baraniuk J N, Thamer M, et al.
Healthcare expenditures for sinusitis in 1996: contributions of
asthma, rhinitis, and other airway disorders. J Allergy Clin
Immunol. 1999; 103:408-414).
[0005] Allergic rhinitis has been reported to affect approximately
17% of the general population in the United States (Ray N F,
Baraniuk J N, Thamer M, et al. Healthcare expenditures for
sinusitis in 1996: contributions of asthma, rhinitis, and other
airway disorders. J Allergy Clin Immunol. 1999; 103:408-414), and
in selected pediatric populations, allergic rhinitis might be
present in up to 42% (Wright A L, Holberg C J, Martinez F D,
Halonen M, Morgan W, Taussig L M. Epidemiology of
physician-diagnosed allergic rhinitis in childhood. Pediatrics
1994; 94:895-901). This amounts to an upper estimate of 60 million
Americans.
[0006] According to the National Sleep Foundation, snoring
currently affects approximately 90 million American adults, 37
million on a regular basis.
[0007] The combined number of those who suffer from rhinosinusitis,
allergic rhinitis, and snoring amounts to a high estimate of 190
million Americans and a low estimate of 128 million Americans, not
accounting for double-counting individuals who may be in two or
more categories. Adopting the conservative assumption of over 40%
duplication yields an estimate of 75 million Americans who suffer
from adverse sinus symptoms and would benefit from an effective
therapy to relieve those symptoms.
[0008] Bathing the nasal and sinus cavities with lightly-salted
water to wash away encrusted mucous, irritants, and foreign
particles, and to shrink the turbinates for the purpose of
improving airflow and relieving nasal congestion has been widely
practiced across many cultures for literally thousands of years.
More recently, and particularly since about 1990, a significant
number of peer-reviewed clinical trials have been undertaken at
leading American and European medical schools and research centers
testing whether the anecdotal claims of relief from the symptoms of
nasal maladies as a result of practicing nasal irrigation, are well
founded and pass scientific scrutiny. (Harvey R, Hannan S A, Badia
L, Scadding G. Nasal saline irrigations for the symptoms of chronic
rhinosinusitis. Cochrane Database of Systematic Reviews 2007, Issue
3. Art No.: CD006394. DOI: 10.1002/14651858.CD006394.pub2.)
[0009] Several clinical studies demonstrate that regular use of
nasal irrigation is an effective therapy to relieve the symptoms of
chronic and acute rhinosinusitis, including statistically
significant findings of reduced nasal congestion, increased nasal
passage airflow, reduced doctor visits, reduced number of
prescriptions for sinus medicine, and improved quality of life.
(Rabago D, Zgierska A, Mundt M, et al. Efficacy of daily hypertonic
saline nasal irrigation among patients with sinusitis: A randomized
controlled trial. Journal of Family Practice.
2002:51(12):1049-1055.) Other clinical studies indicate that
regular nasal irrigation is a beneficial therapy for the treatment
of allergy-related nasal symptoms. (Garavello W, Romagnoli M, Sordo
L, et al. Hypersaline nasal irrigation in children with symptomatic
seasonal allergic rhinitis: a randomized study. Pediatric allergy
and immunology. 2003; 14:140-143.) Other as yet unpublished
clinical studies are currently underway testing whether nasal
lavage is an effective preventive therapy with respect to the
common cold and snoring.
[0010] These studies indicate that nasal irrigation is a clinically
proven method for treating the symptoms of sinus-related disease by
exposing the nasal cavity to a streaming volume of saline. While
the exact mechanism by which nasal irrigation's effectiveness is
achieved is not yet well understood by the medical and scientific
research community, it is likely multifaceted and includes a number
of physiological effects which individually or in concert may
result in an improved ability of the nasal mucosa to reduce the
pathologic effects of inflammatory mediators and other triggers of
allergic rhinitis, asthma and other chronic mucosal reactions, as
follows. First, it rinses the entire interior of the nasal cavity,
washing away encrustations that may be blocking the multiple ostia
that connect the sinus cavities to the nasal cavity, thereby
allowing the sinus cavities to properly drain into the nasal cavity
and making the sinus cavities a much less attractive breeding
ground for the colonization of bacteria. Second, it decreases the
viscosity of the mucous in the nasal cavity, thereby greatly
reducing the formation of interior encrustations. Third, it leaves
a small residue of saline on the interior surfaces of the nasal
cavity, including the openings to the sinus cavities and sometimes
in the sinus cavities themselves. This is beneficial because saline
has an inherently antiseptic quality that hinders the growth of
bacteria. Fourth, exposure of the turbinates, vascular tissue that
warms and humidifies the air inspired through the nose before it
reaches the lungs, to saline causes them to reduce in size, thereby
reducing nasal congestion. Fifth, it improves mucociliary clearance
as a result of increased ciliary beat frequency, which improves the
ability of the mucosa to perform its natural, flushing function.
Sixth, the saline may wash away airborne bacteria, viral particles,
irritants and other foreign particles that cause infections and
allergies. (See: Ponikau J U, Sherris D A, Kephart D M, et al.
Striking deposition of toxic eosinophilic major basic protein in
mucus: Implications for chronic rhinosinusitis. J Allergy Clin
Immunol. 2005; 116(2):362-369.; Ozsoylu S. Nose drops and the
common cold. Eur J Pediatr. 1985; 144:294.; Karadag A. Nasal saline
for acute sinusitis. Pediatrics. 2002; 109:165.; Kurtaran H,
Karadag A, Catal F, et al. A reappraisal of nasal saline solution
use in chronic sinusitis. Chest. 2003; 124:2036-2037.; Georgitis J
W. Nasal hyperthermia and simple irrigation for perennial rhinitis.
Changes in inflammatory mediators. Chest. 1994; 106:1487-1492.;
Talbot A R, Herr T M, Parsons D S. Mucocilliary clearance and
buffered hypertonic saline solution. Laryngoscope. 1997;
107:500-503.; Boek W M, Graamans K, Natzijl H, et al. Nasal
mucociliary transport: New evidence for a key role of ciliary beat
frequency. Laryngoscope. 2002; 112:570-573.)
[0011] There are two methods by which the nasal cavity can be
irrigated: pressure that is positive relative to atmospheric
pressure, and pressure that is negative relative to atmospheric
pressure. Positive pressure can be effected two ways: first, by
gravity, and second, by means of manufactured pressure. Negative
pressure, also called vacuum or suction, can also be effected two
ways: first, anatomically by nasal inhaling or sniffing, and
second, by means of manufactured suction.
[0012] Positive pressure devices that rely on gravity allow the
flow of saline into the nasal cavity by, for example, inserting the
tip of a teapot-like spout into one nostril and pouring the saline
into it. The saline then flows around the posterior margin of the
nasal septum and out the other nostril of the user. An example of a
gravity-based device is the neti pot. However, the awkward physical
position required to accomplish such a rinse is difficult for many
people, and the free flowing effluent from the nasal passageway is
messy so that substantial clean up procedures are necessary.
[0013] Positive pressure devices that rely on manufactured pressure
pump the saline into the nasal cavity, again, by introducing the
saline into one nostril, forcing it under manufactured pressure
around the posterior margin of the nasal septum, and allowing it to
drain out the other nostril. This can be achieved, for example, by
placing the nozzle of a saline-filled, flexible plastic bottle into
one nostril and squeezing it, thereby injecting the saline into one
nostril, through the nasal cavity, and out the other nostril. This
can also be achieved by similarly forcing saline into the nasal
cavity under pressure created by a mechanical pump. Although this
method avoids some of the physical awkwardness needed to achieve a
gravity forced flow, the problems of messiness and the attendant
inconvenience of cleaning remain. In addition, the varied pressures
imparted by a squeeze bottle can impart undesired, painful, and
even harmful pressures throughout the nasal passageway, and
particularly on the Eustachian tube ostia. Thus, this requires some
acquired skill for proper use.
[0014] Earlier nasal lavage devices that relied on negative,
manufactured pressure drew a saline solution through the nasal
cavity by imparting suction to a receptacle bottle or directly to
the nasal cavity, but such devices are large, non-portable,
complex, difficult to operate, and generally require the
supervision and assistance for operation of an attending physician
or medical assistant.
[0015] There is presently no practical device that offers a user
the ability to practice nasal lavage using either or both positive
and negative pressure, whether gravitational, anatomical, or
manufactured, or any combination thereof, in a single handheld
device.
[0016] There is presently no practical device that offers a user
the ability to practice nasal lavage using either or both positive
and negative pressure, whether gravitational, anatomical, or
manufactured, or any combination thereof, in a single, handheld,
powered device.
[0017] There is presently no practical, self-contained device
utilizing separate supply and effluent vessels that offers a user
the ability to practice nasal lavage using either or both positive
and/or negative pressure, whether gravitational, anatomical, or
manufactured, or any combination thereof, in a single, handheld,
powered device.
[0018] There is presently no practical, self-contained device
utilizing separate supply and effluent vessels that offers a user
the ability to practice nasal lavage using either or both positive
and/or negative pressure, whether gravitational, anatomical, or
manufactured, or any combination thereof, in a single, handheld,
portable, powered device.
[0019] There is a need for a convenient hand-held device that can
safely irrigate the nasal cavity with a controlled, gentle supply,
draw the irrigant through the nasal cavity under the influence of
gentle powered suction, collect the effluent safely in a manner
facilitating quick and easy disposal, and is readily adaptable to a
wide variety of nasal dimensions.
SUMMARY
[0020] A nasal lavage device is provided for therapeutic irrigation
of a nasal cavity of a user. The device includes a source of saline
solution, an effluent receptacle, a nasal interface, a vacuum
source, fluid passageways, and a switch and valve assembly. The
fluid passageways include a removable cartridge capable of
effectuating flow reversal through alternative conduit
arrangements. Such a removable cartridge allows a personalizable
fit for individual users, is easily washable, and further includes
seats for removable nasal pillows or domes, which pillows can be
sized to accommodate individual physical requirements due to
different nostril dimensions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is an elevated cross-sectional view of one embodiment
of the subject nasal irrigation system;
[0022] FIG. 2 is a perspective view of the system of FIG. 1;
[0023] FIG. 3 shows a removable nasal interface cartridge which is
intended to engage the receivers of FIGS. 1 and 2 and form a
completely enclosed fluid passageway to communicate fluid to and
from the nasal cavity of a user;
[0024] FIG. 4 is an exploded view of the removable cartridge of
FIG. 3;
[0025] FIG. 5 is a partial exploded view showing the handle housing
and pump;
[0026] FIG. 6 is an elevated view of the fluid passageways and
pressure conduits relative to the caps and pump
[0027] FIG. 7 is a top view of a nasal pillow;
[0028] FIG. 8 is a cross-sectional view taken along lines 15-15 of
FIG. 7; and,
[0029] FIGS. 9 and 10 are perspective views of the nasal
pillow.
DETAILED DESCRIPTION
[0030] The Figures show a nasal lavage device or tool, preferably
easily hand-held in use, which provides a more convenient, cleaner,
more pleasant, and more effective irrigating therapy for the nasal
cavity and sinus ostia. The device 10 is principally comprised of
three components, an irrigant source bottle 12, containing, for
example, saline solution, a receptacle bottle 14 for receiving
saline effluent, and a controller 16 for controlling the
communication of fluid from the first bottle, through the nasal
cavity, and into the second bottle as will be hereinafter more
fully explained. The bottles 12, 14 may be of any of a variety of
shapes and may be attached to the controller in any variety of
manners, such as with a threaded neck, a pinch fit, a bayonet
mount, or the like. A typical size will accommodate 6 to 12 ounces
of fluid. It is envisioned that in one embodiment the first bottle
12, upon being emptied as the result of having been used, can
subsequently be used as the second bottle 14 which upon being
filled with effluent by use can then be thrown away. Accordingly,
in this embodiment the provision of a single bottle provides both
the first bottle of saline source at one time, and then the
effluent receptacle 14 at a next time. It is also within the
intended scope of the present embodiments that either or both of
the bottles may be refillable or reusable, or may even be permanent
chambers within the controller 16 that may be filled or emptied
upon completion of an irrigating therapy. Although saline solution
is mentioned here as the exemplary irrigant, the embodiments are
intended to include alternate irrigants of a variety of saline
mixes including flavorants, aromatics, probiotics or medicines.
[0031] With particular reference to FIG. 1, it is intended in the
present embodiment of this subject nasal lavage system that the
source bottle 12 and the receptacle bottle 14 are disposed
vertically directly over each other for purposes of facilitating
gravitational flow from bottle 12 to bottle 14 and for holding the
controller 16 close to a user's nose in a manner that both
optimizes the user's physical control of the device, and allows the
user to view the depletion of the supply bottle 12 as the system is
being used. Supply receiver 18 and effluent receiver 20 threadedly
receive the bottles 12, 14 and include conduits or ports,
respectively, which comprise the beginning and ending of the fluid
passageway.
[0032] The structure of the supply receiver 18 such that it allows
the supply bottle 12 to be vented to atmosphere. The supply
receiver 18 includes a threaded neck with bottom wall protrusions
that prevent the neck of the supply bottle from bottoming out on
the floor of the receiver 18, thereby providing an air space to
allow air to vent and bubble into the bottle 12 as the saline fluid
flows out. Also, the threads of the receiver 18 do not match the
pitch of the threads of the supply bottle 12, in order to allow air
to pass through and circulate along the thread path from the
atmosphere into the supply bottle 12. The surface tension of the
saline solution through the arcuate threaded path along receiver
threads precludes leaking of supply saline from the receiver
18.
[0033] The effluent receiver 20 includes a sealing o-ring, a
baffle, and a shield. Receiver 20 includes a vacuum port to allow
the pump 120 to impart a slight vacuum to the effluent bottle 14,
as will be more fully explained below. The baffle and shield form a
tortuous path that functions to preclude the saline effluent that
is being intentionally drawn into bottle 14 from also being
unintentionally drawn into the vacuum port and ultimately into the
pump 120. The core of shield through which the effluent saline
passes, may be tapered from top to bottom such that its interior
diameter is smaller at the bottom, in order to increase the
velocity of the effluent saline and thereby decrease the
probability that it will adhere to the sides of the shield as it
passes through it. The circular tip of the shield preferably comes
to a knife edge to reduce surface area and similarly decrease the
probability that effluent saline will cling to the tip due to its
surface tension.
[0034] In FIGS. 3 and 4, a removable cartridge 40 for transporting
the saline from the supply receiver 18 to the effluent receiver 20,
is shown. In particular, a male supply port inlet 42 is inserted in
a supply receiver outlet port and sealed by o-ring 44. Member 42 is
connected to fluid tube 46 which is connected at its other end to
nasal pillow seat 48 extending from cartridge upper housing 50.
Effluent receiver inlet port 24 similarly receives a male effluent
port outlet 52 which is sealed therein via o-ring 54. Flexible tube
56 connects member 52 with nasal pillow seat 58. Members 42,52 are
fixedly received in the cartridge 40 when the upper housing is
secured to the lower housing 60. A projection on the sidewall of
the cartridge 40 aligns the cartridge into closed receptacle in the
handle 16 in a tongue-and-groove manner.
[0035] With attention to FIGS. 1 and 6, it can be seen that
controller 16 comprises a pistol grip type handle having a flat
base portion 80 sized to facilitate the system being independently
supported in a standing position on a flat surface, and a hand
portion 82. The upper portion 84 of the controller 16 comprises a
housing for the fluid passageways and for attached support of the
bottles 12, 14. Flexible nasal pillows 90 are received on the nasal
pillow seats 48, 58.
[0036] Energy is supplied to the system via a disposable or
rechargeable battery 92 in electrical connection with pump 120,
although it is within the scope of the present embodiments that a
corded transformer could similarly supply the energy to the pump.
The system is turned on and off by operator control of a switch 94
on handle 82. Replacement of the batteries is facilitated by a door
98.
[0037] Vacuum is imparted to effluent bottle 14 by pump 120 drawing
air from port 34 through evacuation tube 100, T-fitting 102, and
pump supply inlet tube 104. Air is exhausted to atmosphere through
exhaust tube 106. As a safety precaution to preclude excessive
vacuum pressure in the effluent bottle 14 and its communication to
the nasal cavity of a user, cracking valve 112 will open the
effluent bottle to atmosphere through cracking valve tube 114 when
the vacuum pressure in the system is between about -10 and -20
inches of water, and preferably -15 inches. A plurality of vents
122 are spaced about the perimeter of the upper housing 84 so that
the cracking valve 112 can be exposed to atmosphere despite being
contained within the controller 16. Pump 120 is supported within
the housing by support ribs 124, and the cracking valve is
supported by support rib 126. The cracking valve 112 is preferably
a miniature umbrella valve intended to allow a vacuum limit that
opens suddenly (cracks) at the preferred pressure limit without
preliminary or graduated leaking.
[0038] An elastomeric cover 130 seals the pump control switch in
the handle to resist the switch, batteries, and associated wiring
within the housing.
[0039] There is a feature of the subject embodiment such that the
fluid passageways in removable cartridge 40 can be reversed in
order to reverse the flow through the nasal cavity. In other words,
the presently illustrated embodiment shows that flexible tube 46
communicates the saline to first nasal pillow 130 (FIG. 6), while
second nasal pillow 132 receives the effluent saline and
communicates it to effluent bottle 14 through flexible tube 56. The
flow direction through the nasal cavity can be reversed if flexible
tube 46 is attached to second pillow 132 and flexible tube 56 is
attached to first nasal pillow 130. According to the desires of a
user, the user can select a cartridge, imparting the desired flow
at each particular time of usage. In another embodiment, the nasal
pillows 130, 132 would be situated on a turntable interface
allowing for a reversal of the flow.
[0040] With reference to FIGS. 7-10, not only to preclude leakage,
but also to facilitate flow with gentle pressures for enhanced
therapeutic experience, nasal pillows or domes 90 must be
dimensioned and flexible enough to sufficiently seal against a wide
variety of anatomical variances per user. Accordingly, it is
envisioned that the replaceable pillows are selectively removable
from the cartridge 40 and would come in a variety of sizes, for
example, small, medium, and large. In order to conform to varied
nostril shapes, the domes include a flexible skirt 92, that is
spaced from the central core and tapers towards the opening 94 to
facilitate a seal as the dome 90 is inserted into the nostril. A
female sleeve 96 elastomerically conforms about seats 48, 58 to
preclude leakage between the dome 90 and the cartridge 40.
[0041] The foregoing embodiments are intended to operate in the
following manner: the user lifts the device 10 and positions it so
that the nasal pillows 90 are gently inserted into his or her
nostrils. The conforming flexibility of the pillows makes a seal
easy to achieve without having to force or jam the pillows into the
nostrils. After inserting the device in a proper position, it
should be noted that the supply bottle saline is disposed to
provide positive pressure in the amount of approximately 6 inches
of a water via gravity into the inlet fluid passageway 46 and the
nasal cavity. Such a limited and diminishing amount of pressure by
itself is not typically sufficient to induce a continuous flow of
the saline through the nasal cavity into the effluent bottle 14.
Accordingly, the user presses the switch 94 to turn on the pump 120
to generate a gentle vacuum in the amount of approximately -15
inches of water in the effluent bottle to further induce the flow
of saline into the nasal cavity. Initiation of the saline flow
requires the user's soft palate to be closed thus forming a closed
system of the nasal cavity. This is a natural occurrence that for
most users results merely by breathing through one's mouth.
However, some users find it helpful or necessary to say "ahhh" or
"kahhh" in order to close the soft palate and initiate flow. Once
the flow has commenced into the effluent bottle, it will normally
proceed continuously until the supply bottle 12 is empty, an
occurrence that can be detected by the user visually and by sensing
the cessation of saline into the nasal cavity. The entire
therapeutic irrigation process is usually completed in between 15
and 30 seconds. The saline effluent can then be drained from the
effluent bottle and thrown away. The nasal pillows 90 can be
removed and washed, as can the cartridge 40. The effluent tube 56
can also be washed by a washing rinse or with a cleansing brush
(not shown). The emptied supply bottle 12 can then be removed and
stored, or readily attached to the receiving cap 20.
[0042] Accordingly, in less than a minute, a user has washed and
irrigated the nasal cavity in a safe, gentle and very convenient
manner without any of the mess of neti pots or squeeze bottles, and
with consistent and safe regulation and control over the pressures
induced into the nasal cavity itself.
* * * * *