Nasal dilator

Surgery – Instruments – Internal pressure applicator

Reexamination Certificate

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C128S200240

Reexamination Certificate

active

06375667

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates, generally, to the field of dilator devices for the nose and, in particular, to a nasal dilator to urge the nasal passages of the nose open and for preventing outer wall tissue of nasal passages of a person's nose from drawing in during breathing.
2. Prior Art
A portion of the human population has some malformation of the nasal passages which makes breathing difficult. Examples of such malformations are a deviated septum and swelling due to allergic reactions.
The lower portion of the nostril, immediately above the entrance to the nostril, is known as a vestibule. The vestibule tapers inwardly to a narrowed, neck-like area called the nasal valve. Posterior to the nasal valve, the nasal passages widen out again. Nasal obstructions commonly occur at the nasal valve in individuals who have swelling due to allergic reactions, a deviated septum or similar condition, to the point that the nasal valve may be substantially blocked. Commonly, the lateral wall (i.e., the outer wall tissue of the nasal passage) at the nasal valve is loose with the result that the outer wall tissue draws in during the process of inhalation to substantially or completely block the passage of air through the nasal passage.
Blockage of the nasal passages is obviously an inconvenience to persons who experience this difficulty. In addition, sustained mouth breathing over a long period of time may cause lung irritation due to the inhalation of foreign particles that would otherwise be filtered by breathing through the nose. Blockage of the nasal passages is particularly uncomfortable at night, since nasal blockage can lead to sleep disturbances, sleep irregularities and/or snoring. In addition, a person with such a condition may often awaken because of not easily inhaling sufficient quantities of oxygen.
The most common approach to a serious and chronic nasal blockage problem as described above is a surgical attempt to correct the malformation of the nasal passages. However, surgery is expensive and may not, ultimately, correct the problem.
Another instance wherein enhanced breathing is desirable is during strenuous physical activity including, but not limited to, sports contests. In these cases, the individual needs as much breathing ability as possible to maintain a high level of oxygen intake.
As an alternative to surgery and/or to permit enhanced breathing, nasal dilators for aiding breathing through the nose are generally known. There are several known forms of dilator used for this purpose. One such dilator is in the nature of a band or extension applied to the nose from one nasal passage, over the bridge of the nose, to the other nasal passage. This dilator is formed of a flexible material which has sandwiched with it a resilient spring material. Both the flexible material and the spring are normally planar. When the pad is placed on the nose, it sticks to the skin of the nose, and the action of the spring causes the nasal passages to be urged open.
U.S. Pat. No. 4,414,977 to Rezakhany discloses one such nasal dilator. The nasal dilator includes generally elongated top and bottom rings which are spaced apart and connected together by a rear strut and a front strut. The front strut is longer than the rear strut and includes a bend therein formed at a position close to the front end of the bottom ring. When in place in the nasal passage, the top ring fits in the nasal valve within the nostril to prevent the tissue from being drawn in during inhalation, and to reduce extra flow resistance during exhalation. The bottom ring fits above the entrance to the nostril and serves to stabilize the position of the top ring within the nasal passage. One of these nasal dilators must be inserted into each nasal passage to provide unobstructed breathing.
However, these nasal dilators are uncomfortable to wear because they must be inserted within the nasal passages and may cause irritation and itching. In addition, these nasal dilators must be custom-made to fit each nasal passage of an individual.
Another nasal dilator is disclosed in the U.S. Pat. No.1,292,083 to Sawyer. This nasal dilator includes pads of adhesive material to which are attached metal loops. The pads are applied to the exterior surface of the nose above the nostrils. Once the pads are affixed, a dilating member is connected with each of the loops. The dilating member consists of a metal wire that provides a spring force which is directed outwardly or upwardly when hooked ends of the dilating member are engaged with the loops of the pads.
A further nasal dilator is disclosed in the U.S. Pat. No. 1,950,839 to Chirila. This nasal dilator is similar to that of Sawyer but employs suction cups to secure a dilating member to the exterior surface of the nose.
These nasal dilators are not always effective in insuring free breathing because of the multiple element configurations which are designed to be assembled and then disassembled wherein they can easily become disengaged from the elements (i.e., the pads in Sawyer and the suction cups in Chirila) that secure the dilating members to the exterior of the nose. This unwanted disengagement of the elements could result in injury to the wearer of the nasal dilators.
A still further nasal dilator is disclosed in the International Application Published Under The Patent Cooperation Treaty WO 92/22340 to Johnson. This nasal dilator comprises a truss member that includes a flexible strip of material having a first end region, a second end region and an intermediate segment. The first and second end regions are adapted to engage the outer wall tissue of first and second nasal passages of the nose and are secured thereto via an adhesive substance. The truss member further includes resilient bands that are secured to the strip of material by way of strips of double-sided adhesive foam tape. The resiliency of the bands acts to stabilize the outer wall tissue and thereby prevents the outer wall tissue of the nasal passages from drawing in during breathing.
The curved ends of the strip of material extend past angled ends of the resilient bands. However, the nasal passages are not urged open as much or as little as they could usefully and safely be opened. Also, this device consists. of multiple components forming the pad in a sandwich relationship which arrangement is unduly complicated.
Other Patents of Interest
U.S. Pat. No. 5,546,929, NASAL DILATOR, J. D. Muchin.
U.S. Pat. No. 5,533,499, NASAL DILATOR, B. C. Johnson.
U.S. Pat. No. 5,533,503, NASAL DILATOR, W. J. Doubek et al.
Other Publications
Petruson, Bjorn, “Snoring Can Be Reduced When the Nasal Airflow is Increased by the Nasal Dilator Nozovent”,
Arch. Otolaryngol Head Neck Surg.
(1990) vol. 116, pp. 462-464.
Petruson, Bjorn; “Improvement of the Nasal Airflow by the Nasal Dilator Nozovent”,
Rhinology,
vol, 26, pp. 289-292 (1988).
Petruson, Bjorn; “Decreased Nasal Resistance by the Nasal Dilator Nozovent® can Reduce Snoring”, World Congress on Chronic Rhonchopathy (May 1989).
Petruson, Bjorn et al.; “The Importance of Nose-breathing for the Systolic Blood Pressure Rise During Exercise”,
Acta Otolaryngol,
Stockholm, 109: 461-466, (1990).
E. N. T. Spring Symposium; “Report of a Symposium at the Royal Society of Medicine, London, May 21, 1991” pp. 1-4, A Simple, but Effective Way to Treat Snoring, Petruson.
Petruson, Bjorn; “Two New Ways for Nasal Administration of Drugs with the Nasal Dilator Nozovent”, Abstract, ENT-Department, University of Goteborg, University of Goteborg, Sahlgrens's Hospital, 413, 45 Goteborg, Sweden.
Hoijer, Ulf, et al., “The Effects of Nasal Dilation on Snoring and Obstructive Sleep Apnea”,
Arch. Otolaryngol Head Neck Surg.
(1992) vol. 118, pp. 281-284.
Lancer, J. M., et al., “The Francis Alae Nasi Prop and Nasal Airway Resistance to Airflow,”
The Jounal of Laryngology and Otology (
1986) vol. 100, pp. 539-541.
Ford, Charles, et al., “A Nasal Prothesis for Treatment of Nasal Airway Obstruction, ”
Rhinology (
1985) vol. 23, pp. 223-229.
SUMMARY OF THE

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