Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...
Reexamination Certificate
1998-05-01
2001-05-29
Lewis, Kim M. (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material applied to or removed from external...
C604S094010
Reexamination Certificate
active
06238377
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention relates generally to a nasal-nasopharyngeal-cleaning (NNC) system to be used in removing harmful substances from a human's nasal and nasopharyngeal cavities. Harmful substances include infectious agents, chemicals, dust, solidified mucous and dirt which adhere to the nasal cavities and the nasopharynx. The NNC system of the present invention comprises the NNC solution and its container, a liquid transferring tubing system, optionally, a valve for controlling the NNC solution flowing through the NNC system and a flat-head nostril fitting which optionally comprises a means for holding the nostril fitting against the nostrils. A two-step method of using the NNC system is also provided.
BACKGROUND OF THE INVENTION
Influenza viruses A, B and C; respiratory syncytial viruses A and B; parainfluenza viruses and the like are common causes for respiratory tract infections in humans. Presently, there are no effective drugs or vaccines to treat or prevent these viral infections. Human adults and school children are constantly exposed to these infectious agents at work and/or at school and may also be carriers of these infectious agents to and from the home. A practice of nasal and nasopharyngeal cleaning can reduce the microbial load of those tissues and reduce the chance of spreading these disease-causing microorganisms at home, school and at work.
Many disease-causing agents exist in the nasal and nasopharyngeal cavities. The shedding of communicable infectious microorganisms in the nasal and nasopharyngeal cavities causes spreading of the disease from the upper respiratory tract to the lower respiratory tract of the carrier. Shedding also causes the spreading these infectious agents to other people through sneezing and/or coughing (Hall, C. B., Douglas, R. J., in an article entitled: “Quantitative shedding patterns of respiratory syncytial virus in infants”,
Journal of Infectious Diseases,
132: 151-156, 1975; and Hall, C. B., Geiman, J. M., Breese, B. B., and Douglas, R. J., in an article entitled “Parainfluenza virus infections in children: Correlation of shedding with clinical manifestations”,
Journal of pediatrics,
91: 194-198, 1977). For most viral infections, antibiotic prevention and/or treatment is generally ineffective. It would thus be beneficial to have a practical system and/or method to remove these disease causing agents from the human body. In a manner similar to brushing one's teeth, nasal and nasopharyngeal cleaning in the general population will have a number of healthy benefits.
Nasal washes, nasopharyngeal swabbing and nasopharyngeal aspiration have previously been used to obtain specimens from patients for the determination of microbial pathogens (Hall, C. B., Douglas, R. J., in an article entitled: “Clinically useful method for the isolation of respiratory syncytial virus”,
Journal of Infectious Diseases,
131: 1-5, 1975). However, these procedures and devices were used only to obtain samples and are not effective in removing the infectious agents from the nasal and nasopharyngeal cavities of a human.
Ephedrine nasal washes have been used in the treatment of sinusitis and other nasal and paranasal symptoms and allergic rhinitis, (Shaikh, W. A., in the
Journal of Allergy Clinical Immunology
, Vol. 96, No. 5, part 1: 597-600, 1995). The Shaikh procedure uses a 1% ephedrine hydrochloride solution in a normal saline solution and a Higginson's rubber syringe. After the rubber syringe was filled with the wash solution, the nozzle of the syringe was introduced into one nostril and the bulb of the syringe was pressed to push the fluid into the nasal cavity. As described by the author, most of the fluid exited from the same nostril, but some fluid exited through the other side of the nose after passing through the nasopharynx. This procedure was performed once every forty-eight (48) hours for a four (4) week period and caused a significant improvement in symptom scores and peak nasal inspiratory flow rates in patients with perennial allergic rhinitis as compared to those treated with a placebo wash (normal saline only). This procedure, however, has the following disadvantages:
(1) ephedrine was the key factor for the effectiveness of this procedure, but this chemical is not suitable for use by the general public on a daily basis;
(2) this procedure was performed only on patients with perennial allergic rhinitis;
(3) this procedure was mainly washing of the nasal cavity, the nasopharyngeal cavity was largely uncleaned;
(4) the apparatus used was clumsy and uncomfortable to use; and
(5) this procedure was performed once every forty-eight (48) hours which is not frequent enough to remove harmful materials from the nasal and nasopharyngeal cavities on a daily basis.
The Shaikh procedure would permit the infectious microorganisms to be brought into and spread around at home, office, school, or day care center. Therefore, there is a need to develop a generally acceptable and more effective nasal and nasopharyngeal cleaning system.
Nasal and nasopharyngeal cavities are common places for holding environmental allergens, such as pollen, fungal spores, animal body-originated dustings and volatile chemicals. These harmful agents cause allergic reactions and other ill consequences. Nasal and nasopharyngeal secretions combine with environmental particles to form big matters (solidified mucous) in the nasal cavity. These big matters narrow the airway and make the individual feel uncomfortable. Prior to the present invention, an apparatus and method to easily and effectively remove harmful agents from the nasal cavity and to prevent the formation of and remove the big matters in the nasal cavity has not been available to medical professionals and to the general public.
The human body is the only natural host for many kinds of pathogenic microorganisms. Nasopharyngeal mucous is one of the prominent places of viral shedding. These pathogens include, but are not limited to, influenza viruses, respiratory syncytial viruses and the like. The nasopharyngeal shedding of these pathogens is the major cause of person-to-person transmission. One skilled in the art will appreciate that those communicable pathogenic microorganisms present in the nasal and nasopharyngeal cavities will be decreased in quantity after the cavities have been cleaned. After nasal and nasopharyngeal cleaning, these infectious agents will be less likely to spread horizontally to non-carriers and/or vertically to the lower respiratory tract of the carrier.
Environmental pathogens can be encountered by inhalation.
Legionella pneumophila
, the causative agent of Legionnaire's disease presents in aerosols. It is generated from air conditioning cooling towers, cold water taps, showers and other water systems. Depending upon wind speed,
Legionella pneumophila
, in these aerosols, can be carried up to 500 meters and infect a large number of individuals. Promptly removing these aerosols from the nasal and nasopharyngeal cavities will greatly reduce the incidence of infection.
Several methods have been reported to be useful in cleaning nasal and nasopharyngeal cavities. Grossan invented a nasal irrigation system (NASAL IRRIGATION SYSTEM, U.S. Pat. No. 3,047,145, issued Nov. 12, 1974) which provided for an isotonic saline solution under pressure flowing into one nostril, passing through the nasolacrimal duct, where the solution passes, sequentially, into the ostia of the frontal sinus, the ethnoids, the maxillary and the sphenoid. The solution then moves past the outlet of the eustachian tube and then through the nasopharynx to the upper posterior portion of the other nostril and outwardly therethrough, passing the same ducts and ostia, in reverse sequence, before being discharged from the second nostril. This system has numerous and serious shortcomings. First, the cleaning solution cannot be completely drained from the deep regions of certain sinuses due to their cavity structure. Second, certain infectious agents might be moved from one place to anot
Lewis Kim M.
Standley & Gilcrest LLP
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