Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
2000-05-26
2004-07-27
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S404000, C424S434000
Reexamination Certificate
active
06767537
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
The present invention relates generally to ailments of the sinuses in humans. More particularly, the present invention pertains to a composition and method for the treatment of sinusitis in humans. The composition includes the bacteria
Lactobacillus acidophilus
as an anti-fungal agent in distilled water as a carrier.
2. Summary of Related Art
Formed within the bones of the human skull are four sets of open spaces which define the nasal sinuses. These spaces include a pair of frontal sinuses located above the eyes, a pair of maxillary sinuses located to either side of the nose, a pair of sphenoid sinuses located behind the bridge of the nose, and a pair of ethmoid sinuses located in the upper nose. Through the formation of a surprisingly large amount of mucous fluid (about 1 liter per day), the sinuses help to drain and continually clean the nose. The sinus membranes are lined with cilia which move in wave-like fashion and, by movement of the mucous fluid thereover, aid in the flushing and cleansing of the sinus cavities.
In their ordinary and healthy condition, the sinuses allow for the free passage of air and the equalization of air pressure. Mucous fluid flows from the sinuses and drains into the nose. However, when the passageways are obstructed, fluid cannot pass freely through the sinuses, and the sinus cavities fill with fluid and are blocked. Symptoms of sinus blockage include coughing, facial pressure, congestion, and fatigue. Sufferers of sinusitis frequently confuse sinusitis for another ailment, such as a cold, a flu, or a sore throat.
Blockage of the sinuses is typically the result of inflammation of the sinus cavities. This inflammation, known as “sinusitis,” is the result of undrained mucous in one or more of the sinus cavities. There are a variety of causes of sinus inflammation, although the typical causes include the presence of fungi, bacterial and viral infection, or allergens. Other causes include obstructions due to a deviated septum and nasal polyps which form in the nasal passages and which obstruct breathing. Regardless of the cause, inflammation of the sinus cavities causes the swelling and congestion of membranes associated with the sinuses. Pain results from the congestion, mucous production increases and the mucous itself becomes thicker.
Sinusitis takes a large toll on the health of Americans and places a heavy tax on health care systems. Unexpectedly, sinusitis is more common than hypertension or arthritis. Over 500,000 visits occur annually to the emergency room by people who suffer from sinusitis.
Sinusitis may be either acute or chronic. Acute sinusitis is frequently subsequent to a cold and follows a relatively brief course of between several days and three weeks. Acute sinusitis may be caused by viral or bacterial infection of the nose, the throat, and the upper respiratory tract. A typical cause is the common cold. Antibiotics and decongestants are the medications of choice and, if regimented properly, can provide good response. Between 60% and 70% of all cases of acute sinusitis may be classified as acute.
Chronic sinusitis is defined as sinusitis lasting for more than 30 days. Bouts are frequent throughout the year. Symptoms of chronic sinusitis include runny nose, congestion, headaches, and diminished sense of smell. In addition to being of longer duration than acute sinusitis, chronic sinusitis is more difficult to treat with conventional decongestants and antibiotics. Over 40 million Americans suffer from chronic sinusitis annually.
Practitioners and researchers have traditionally believed that chronic sinusitis was generally caused by bacteriological infection. Based upon this understanding, the regimen for treatment naturally has included antibiotics. Yet success with this treatment has not been as high as for treatment of acute sinusitis, and health practitioners and researchers have long puzzled over this apparent inconsistency. Recently, however, the Mayo Clinic announced that chronic sinusitis is probably caused by fungi in the mucous of sufferers. In fact, the research showed that it was the patient's immune system response which was the cause of chronic sinusitis. For the first time, researchers now have an understanding of the reason that a regimen of antibiotics has proven largely ineffective against chronic sinusitis.
Accordingly, traditional techniques have failed to produce satisfactory results in the resolution of chronic sinusitis. An improved method of treatment remains wanting.
SUMMARY OF THE INVENTION
Accordingly, it is the general object of the present invention to provide a composition and method for treatment of chronic sinusitis.
More particularly, it is a further object of the present invention to provide such a composition and method which is directed to the regulation and limitation of the irritating fungus which is present in the sufferer's mucous.
Still a further object of the present invention is to provide such a composition and method which utilizes bacteria to re-establish a healthy, bacteria-based flora on the sinus membranes.
An additional object of the present invention is to provide such a composition and method in which the preferred bacteria are selected from the genus Lactobacillus and the genus Bifidobacterium.
Yet another object of the present invention to provide such a composition and method which is provided in the form of a spray.
Still a further object of the present invention is to provide such a composition and method which is alternatively provided in the form of a flush.
These and other objects are accomplished by the provision of a composition and method for the treatment of chronic sinusitis in which a composition containing “friendly” colonial bacteria is applied externally in the form of either a spray or a flush. The bacteria are selected from sugar-consumers which produce at least lactic acid and hydrogen peroxide as part of their end product. The lactic acid produced by the selected bacteria creates an antifungal environment which also inhibits a variety of pathogens, while the hydrogen peroxide is known to act anti-pathogenically to reduce infection. (Ironically, and with respect to the antifungal characteristics of lactic acid, the very treatment which has been traditionally used to treat chronic sinusitis—an intense regimen of antibiotics—produces the opposite result by destroying the “friendly” lactic acid-producing bacteria, thus effectively worsening the situation.)
The preferred bacteria are selected from the genus Lactobacillus and the genus Bifidobacterium. Both are anaerobic, nonsporeforming, Gram-positive rods. Both undergo fermentative metabolism in which the end product is at least partially lactic acid. A variety of members of the Lactobacillus genus are ordinarily found in the normal flora of the human mouth and intestinal tract. Bifidobacterium are ordinarily found in the intestinal tracts of babies.
Many Lactobacillus and Bifidobacterium may be used, alone or in combination.
The selected bacteria are provided in a therapeutically effective amount in a distilled water solution.
The following is a detailed description of the invention, and a summary of certain tests and results which demonstrate the effectiveness of the composition and its prescribed method of treatment.
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Dickinson Wright PLLC
Flood Michele C.
Moga Thomas T.
Tate Christopher R.
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