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Title: Composition for cleansing the sinuses
United States Patent: 6,899,903
Issued: May 31, 2005
Inventors: Quillin; Patrick (Box 130789, Carlsbad, CA 92013)
Appl. No.: 601510
Filed: June 23, 2003
Abstract
A unique and synergistic composition is disclosed for cleansing the
sinuses to reduce inflammation and improve breathing. The disclosure is also
related to a composition for freshening and cleansing the sinus cavities and
nostrils that includes a homeopathic ingredient and saline carrier solution.
The disclosure is also related to the use of such composition to provide
many anticipated and unexpected benefits that emanate from cleansing debris
and microbes from the sinuses and nostrils.
Description of the Invention
1. Field of the Invention
The present invention relates to non-prescriptive compositions that have
anti-microbial activity in cleansing the sinuses, and thus alleviating
sinusitis, apnea, asthma, or other related upper respiratory infections and
inflammatory conditions.
2. Background of the Invention
SINUS CAVITIES. The human head contains 4 sets of air-filled cavities known
as the paranasal sinuses (Stedman's Medical Dictionary, 27th
Edition, page 1644, 1999). The purpose of the sinuses appears to be both the
filtration and warming of air as it enters the lungs. The location of the
sinuses is from nostril entrance into the back of the throat and other
passageways and cavities within the human head. Specifically, the four pairs
of paranasal sinuses are the frontal sinuses (located in the forehead), the
maxillary sinuses (located behind the cheekbones), the ethmoid sinuses
(located between the eyes), and the sphenoid sinuses (located behind the
eyes).
The membrane lining the sinuses secretes mucus, which contains antimicrobial
agents (such as antibodies) and is sticky in texture to capture small
particles and infective microbes. Other protective mechanisms in the human
sinsuses include cilia, which are small hair-like projections located in the
nostril which normally beat in unison to propel mucus outward, thus
expelling infective microbes and other irritant particles. While the air we
breath is filled with yeast spores, viruses, bacteria, and other irritants;
a healthy human sinus passage possesses the host defense mechanisms to kill
the invading microbes and wash away the irritants.
For healthy sinuses to be present, the mucous membranes must be intact, and
the sinus passages must be open to allow drainage and circulation of air
through the nasal passage. In fact, due to the inherent conditions of
warmth, moisture, darkness, sugar substrate for microbes (mucus), and
stagnation; the environment of the nasal passages is vulnerable to microbial
infections. Sinusitis (inflammation of sinus passages), sleep apnea
(cessation of breathing while sleeping), asthma (inflamed bronchial tubes
leading to the lungs which causes labored breathing), otitis media
(inflammation of the middle ear), headaches, snoring, and more can all be
caused by infections and/or inflammation of the sinus passages.
Sinusitis
Sinusitis is an inflammation of the membrane lining one or more paranasal
sinuses. According to the Center for Disease Control, thirty seven million
cases of chronic sinusitis are reported annually, making this condition one
of the most commonly reported reasons for patient visits to a family
physician. There are three primary types of sinusitis:
 | a) acute (short in duration and infrequent in occurrence) |
 | b) recurrent acute (occurs more often, but leaves no lasting damage to
tissue) |
 | c) chronic (lasting longer than 3 weeks, and may cause tissue damage)
|
Causes of Sinusitis
Most common cause of sinusitis is a viral cold that infects the upper
respiratory tract and causes obstruction (online report from Etkins, et al.,
1999, Nidus Information Services, Inc., Well-Connected Report: Sinusitis,
Jun. 1999, www.well-connected.com). Once obstruction has occurred, the
stagnated environment is hospitable for bacteria. Most common bacteria
linked to acute sinusitis are Streptococcus pneumoniae, H. influenzae
(common bacteria associated with respiratory infections in children), and
Staphyloccocus aureus.
Fungi may also cause sinusitis. Researchers have found that 96% of chronic
sinusitis patients have fungi present in their mucus smears (Mayo Clinic
Proceedings, vol.74, p.877, 1999). Most common fungal species found in the
nasal smears in this study included: Alternaria, Aspergillus, Candida,
Cladosporium, Fusarium, and Penicillium. Fungal infections are
more common in people with diabetes, leukemia, AIDS, conditions that impair
the immune system, and those who consume medication that may impair immune
functions, including corticosteroids. Fungal sinusitis usually occurs more
often in warmer humid climates.
Chronic or recurrent acute sinusitis can become lifelong conditions that can
damage surrounding tissues, including the creation of polyps, enlarged
adenoids, cleft palate, or tumors.
Symptoms of Sinusitis
Nasal congestion and discharge which is thick and yellow or yellow-green are
common symptoms of acute sinusitis. Pain in face and headache may also
occur. Persistent cough may occur throughout the day. Fever may be present
(Williams, M L, THE SINUSITIS HELP BOOK, Wiley, N.Y., 1998). Nasal
congestion and obstruction are common in recurrent acute and chronic
sinusitis, with symptoms lasting more than 2 months, even during non-allergy
seasons. Chronic cough, post nasal drip, yellowish mucus discharge, and bad
breath may result.
Depending on where the infections occurs, subsequent pain can occur. Frontal
sinusitis causes pain across the lower forehead. Maxillary sinusitis may
cause pain in the teeth, palate of the mouth, and cheek region.
Ethmoid sinusitis may cause pain behind the eyes. Sphenoid sinusitis may
cause pain behind the eyes, across the forehead, or in the facial region
(Rosin, D F, THE SINUS SOURCEBOOK, Contemporary, Chicago, 1998). Sinusitis
of all forms is usually non-life threatening, yet can be debilitating with
pain, side effects of medication, and the poor health that results from
inability to breath fully.
Treatments of Sinusitis
Typical medical therapy for upper respiratory infections involves (Bruce &
Grossan, THE SINUS CURE, Balantine, N.Y., 2001):
 | a) antimicrobials, such as antibiotics |
 | b) antisecretory agents, to shut down the flow of mucus |
 | c) anti-inflammatory agents, such as steroids (i.e. prednisone), to
reduce the swelling from the infection |
Home remedies for sinusitis include steam inhalation and warm compresses
over the region to relieve discomfort (MacFarlane, M., THE SINUS HANDBOOK,
USRP, Encinitas, Calif., 1997). Many over-the-counter (OTC) preparations are
available, including decongestants that are delivered as tablets, sprays, or
vapors. Prescription drugs and surgery are expensive and ladened with side
effects and risks.
A Summary of the Properties of Ingredients of the Composition Baptisia
Tinctoria
This agent is a homeopathic ingredient. The word "homeopathy" derives from
the Greek word homoios meaning "similar" and pathos, meaning "suffering".
Based on the principle of "like cures like", homeopathic remedies are
dilutions of natural agents, including extracts from plants, animals, and
minerals. Homeopathy was founded in the late 18th century in
Germany by a physician, Samuel Hahnemann. Dr. Hahnemann found that by
ingesting extract of cinchona, which contains quinine that is used to cure
malaria, he was able to develop the well-known symptoms of malaria. Hence,
the expression "like cures like"(ALTERNATIVE THERAPIES, p. 272, Future
Medicine Publishing, Puyallup, Wash., 1993). Homeopathy uses an official
compendium, HOMEOPATHIC PHARMACOPOEIA OF THE UNITED STATES, and has several
main principles:
 | a) Like cures like, law of similars |
 | b) The more a remedy is diluted, the greater its potency, law of
infinitesimal dose |
 | c) An illness is specific to the individual |
While most of modern allopathic drugs block biochemical pathways,
homeopathy uses a more subtle energy system with no known side effects or
deaths in its 180 year history. Over a half a billion people around the
world use homeopathy as adjunctive or primary care for illness. The World
Health Organization has cited homeopathy as one of the systems of
traditional medicine that should be integrated worldwide to provide adequate
global health care. Essentially, homeopathic remedies are extremely dilute
mixtures of the substance that would induce the same symptoms one is
attempting to cure. A 12× remedy, as is found in this invention, has been
diluted 1012 times. Homeopathic remedies are diluted then shaken
(succussion). Baptisia tinctoria is considered to be antimicrobial in
homeopathic medicine. The United States Food and Drug Administration
recognizes homeopathic remedies as official drugs and regulates their
manufacturing, labeling, and dispensing; although homeopathic remedies are
not prescription drugs.
OREGANO is an antimicrobial herb with GRAS (generally regarded as safe)
status with the Food and Drug Administration.
COLLOIDAL SILVER also has GRAS status and is a suspension of silver
particles in water solution that exhibits antimicrobial activity.
GRAPEFRUIT SEED EXTRACT has GRAS status and is an extract from grapefruit
seed with antimicrobial activity.
BENZALKONIUM CHLORIDE is an FDA-approved preservative with antimicrobial
value.
SUMMARY OF THE INVENTION
It is, therefore, one of the principle objects of the present invention
to eliminate microbes in the sinus passages that may cause inflammation and
infections.
Another object of the present invention is to provide a composition which
may be conveniently introduced through the nose with a simple plastic
squeeze bottle which causes no discomfort to the user.
A further object of the present invention is to provide a simple, non-toxic,
non-prescription, and effective means at reducing pathogenic microbes, dust,
pollen, and general debris in the sinus passages for the immediate and
residual benefits of improved health and reduced symptoms.
These and additional objects are attained by the present invention which, in
the broadest sense, comprises a collection of synergistic and non-toxic
agents that cleanse the sinuses, eliminate infectious agents, reduce
swelling, and accelerate recovery from sinusitis without significant side
effects.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention is a liquid or vapor that is inhaled, squirted, or
vaporized into the nostrils and sinus cavities. It is of particular utility
for use by persons who suffer from sinusitis, common colds, work around dust
or fumes, travel by airlines often, or suffer from pollen and other
allergies.
The composition includes a carrier, which can be water or dilute saline
(salt water) solution. Saline solution is preferred since it confers an
additional mild antimicrobial activity to the composition. Saline mists are
commonly used by people with sinus congestion. Saline solutions are commonly
sold at pharmacies as OTC preparations for sinus problems. Saline solutions
are safe, but not sufficiently antimicrobial to resolve most cases of
chronic sinusitis. Isotonic saline solutions, as found in this invention,
attempt to mimic the concentration of salt in human bodily fluids, hence
they usually do not irritate the sinus membranes.
Control and/or elimination of infective microbes in the sinuses can be
achieved by using the ingredients listed in this patent: Baptisia
tinctoria 12×, colloidal silver, grapefruit seed extract, and oregano.
Other agents that may be of benefit in this nasal solution include, but are
not limited to: oil of peppermint, spearmint, eucalyptol, methyl salicylate,
and various other non-toxic, non-prescription antimicrobials.
The delivery method used for this composition can vary from plastic squeeze
bottle, which squirts the composition into the sinus cavities, to an
atomizer, or pump mister, which sprays fine particles of the composition
into the sinuses.
No unusual discomfort for the user has been experienced in the 4000 people
who have used this product. Many of the users have been afflicted with acute
chronic sinusitis, hence inflamed mucus membranes can be fragile, even when
saline solution is sprayed into the nose.
There are numerous advantages from the use of the composition. Nearly forty
million Americans suffer from chronic sinusitis. Some of these people take
prescription drugs, such as antibiotics, which may invite a fungal
infection. Some of these people may use systemic steroid medication, which
suppresses immune functions and has long term complications. Some of these
people may use OTC products which induce drowsiness and could raise the risk
for automobile accidents or other. By using the composition, these sinus
sufferers can avoid the many side effects, high cost, and ineffectiveness
that are often associated with traditional treatments for sinusitis.
Selected Case Studies Showing Successful Use of the Composition
Person 1: Male 51 years old. Experienced sinus congestion periodically for
the past 40 years. Experienced blood in the nose for the past 10 years.
Problem would worsen in certain climates and at certain times of the year,
but never got better. Tried various over the counter sinus preparations,
changed diet, took nutrition supplements-all to no avail. Used the
composition for one week and began to feel significant relief. Blood in nose
stopped. Congestion cleared up substantially. With continued use, claims
breathing better than in the past 40 years.
Person 2: Female 62 years old. Experienced sinus congestion for 30 years,
including regular use of over the counter sinus medications. Had undergone
sinus surgery, which did not clear the problem. Began using the composition
and felt substantial immediate relief. After 4 days of use, found green and
yellow fungal balls expelled in mucus. Continued use of this product
provides significant relief from sinus congestion and easier breathing.
Person 3: Female 65 years old. Experienced sinus congestion for 40+ years.
Used many prescription and non-prescription medications for minor temporary
relief of symptoms. Within 2 days of using the composition reported major
improvements in breathing.
One individual who used the composition cancelled sinus surgery, due to the
dramatic improvement from using the composition. Some individuals who used
the composition have been able to cease dependency on inhalers, OTC, and
prescription medication. Others have found improvements in apnea, snoring,
sinus headaches, and asthma. Some individuals who used the composition have
reported reduction in the incidence of colds after frequent airplane trips.
If one examines a typical home air filter unit in the air conditioning or
furnace, it is easy to see the pollen, dust, and debris that can accumulate
in the sinus passages. Since the nose and sinuses work in a similar fashion
by filtering the air entering the lung passage, regular cleansing of the
sinuses with the composition has been shown to improve many aspects of
health, including reduction in sinusitis and easier breathing.
EXAMPLE FORMULA FOR COMPOSITION
The following formula provides a representative example of the
composition, including both percentages and amount used in a typical 4 ounce
bottle:
| INGREDIENT |
common concentration |
ranges claimed |
| Baptisia tinctoria 12x |
99.2% |
117.33 milliliters |
1% to 99% |
| Colloidal silver |
0.565% |
0.668 ml |
0.01% to 10% |
| Grapefruit seed extract |
0.07% |
0.0834 ml |
0.01% to 5% |
| Oregano juice |
0.07% |
0.0834 ml |
0.01% to 5% |
| Sodium chloride (salt |
0.75% |
887.1 mg |
| USP) |
| Benzalkonium chloride |
0.01% |
0.023656 ml |
| Sodium hydroxide to adjust pH to 6.2 (less than 1 ml) |
The above listed formula for the composition has undergone extensive
testing in 4000 users and has demonstrated exceptional effectiveness at
cleansing the sinuses, reducing symptoms of sinusitis, and bringing about
easier breathing.
Claim 1 of 3 Claims
1. An aqueous solution for treating sinusitis adapted to be sprayed into
a nasal cavity, said solution comprising:
a) Baptisia tinctoria 12× from 1% to 99%, by vol,
b) colloidal silver from 0.01% to 10%, by vol,
c) grapefruit seed extract from 0.01% to 5%, by vol,
d) oregano juice from 0.01% to 5%, by vol.
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If you want to learn more
about this patent, please go directly to the U.S.
Patent and Trademark Office Web site to access the full
patent.
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