Surgery – Miscellaneous – Methods
Reexamination Certificate
2000-06-30
2002-08-27
Winakur, Eric F. (Department: 3736)
Surgery
Miscellaneous
Methods
C600S529000
Reexamination Certificate
active
06439238
ABSTRACT:
I. BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention pertains to a diagnostic and treatment for snoring. More particularly, this invention pertains to a method for diagnosing a patient's susceptibility to a snoring treatment by temporarily stiffening tissue suspected of contributing to snoring.
2. Description of the Prior Art
Snoring has received increased scientific and academic attention. One publication estimates that up to 20% of the adult population snores habitually. Huang, et al., “Biomechanics of Snoring”,
Endeavour
, p. 96-100, Vol. 19, No. 3 (1995). Snoring can be a serious cause of marital discord. In addition, snoring can present a serious health risk to the snorer. In 10% of habitual snorers, collapse of the airway during sleep can lead to obstructive sleep apnea syndrome. Id.
Notwithstanding numerous efforts to address snoring, effective treatment of snoring has been elusive. Such treatment may include mouth guards or other appliances worn by the snorer during sleep. However, patients find such appliances uncomfortable and frequently discontinue use (presumably adding to marital stress).
Electrical stimulation of the soft palate has been suggested to treat snoring and obstructive sleep apnea. See, e.g., Schwartz, et al., “Effects of electrical stimulation to the soft palate on snoring and obstructive sleep apnea”,
J. Prosthetic Dentistry
, pp. 273-281 (1996). Devices to apply such stimulation are described in U.S. Pat. Nos. 5,284,161 and 5,792,067.
Surgical treatments have been employed. One such treatment is uvulopalatopharyngoplasty (“UPPP”). In this procedure, so-called laser ablation is used to remove about 2 cm of the trailing edge of the soft palate thereby reducing the soft palate's ability to flutter between the tongue and the pharyngeal wall of the throat. The procedure is frequently effective to abate snoring but is painful and frequently results in undesirable side effects. Namely, removal of the soft palate trailing edge comprises the soft palate's ability to seal off nasal passages during swallowing and speech. In an estimated 25% of uvulopalatopharyngoplasty patients, fluid escapes from the mouth into the nose while drinking. Huang, et al., supra at 99. UPPP is also described in Harries, et al., “The Surgical treatment of snoring”,
Journal of Laryngology and Otology
, pp. 1105-1106 (1996) which describes removal of up to 1.5 cm of the soft palate.
Huang et al. describe treating snoring by stiffening the soft palate through laser scarring. This includes laser scarring of the surface of the soft palate. Another technique involves RF ablation of the tissue of the soft palate. Available through Somnus Medical Technologies, Inc., this technique inserts a needle into the soft palate. The tip of the needle generates RF energy to ablate and scar the soft palate tissue. This technique is illustrated in U.S. Pat. No. 5,718,702. Debate continues as to the permanency and efficacy of such treatments.
A preferred technique is disclosed in commonly assigned and co-pending U.S. patent application Ser. No. 09/513,432. According to certain embodiments of that application, permanent implants are placed in the soft palate to add stiffness to the soft palate.
Since snoring can be attributed to vibratory motion at different locations in the naso-pharyngeal area, a snoring treatment may not be as effective as possible. For example, a soft palate treatment will not be effective if offensive snoring sounds are due principally to vibratory motion in the nasal concha or the pharyngeal wall.
Efforts to isolate or determine the contributory nature of snoring location include measuring the frequency of the snoring sound. Empirical data reveal that the palatal snoring produces a different pitch than, for example, nasal snoring. One product and service that is used to record snoring and compare to empirical data for such an assessment is available from Snap Industries, LLC, Glenview, Ill., USA. The acoustics of snoring is described in Dalmasso et al., “Snoring: analysis, measurement, clinical implications and applications”,
European Respiratory Journal
, pp. 146-159 (1996).
Another diagnosis technique to identify a location of airway obstruction is to insert a tube into the throat. Sonic signals are sent down the tube and reflected waves are noted and recorded. Location of obstruction of the airway can be determined by measuring the reflected sound wave.
Notwithstanding the foregoing, a continuing need exists to diagnose snoring. For example, empirical data is mixed and only partially reliable. Under the previous techniques, the diagnosis locates a snoring source but cannot accurate predict the efficacy of a treatment for a particular person. Further, the techniques can be expensive requiring expensive equipment as well as patient discomfort.
II. SUMMARY OF THE INVENTION
According to a preferred embodiment of the present invention, a diagnostic method is disclosed for indicating a patient's susceptibility to treatment of snoring by stiffening a region of the patient's a naso-pharyngeal area. The method includes applying a stiffening agent to an outer surface of the region of the naso-pharyngeal area. The stiffening agent is left in place on the outer surface for at least a temporary period of time. During the temporary period of time, observation is made of any abatement of snoring. According to an alternative embodiment, the agent is left in place for extended periods or re-applied as desired for a snoring treatment.
REFERENCES:
patent: 4830008 (1989-05-01), Meer
patent: 5284161 (1994-02-01), Karell
patent: 5718702 (1998-02-01), Edwards
patent: 5792067 (1998-08-01), Karell
patent: 5804211 (1998-09-01), Robertson et al.
patent: 5900245 (1999-05-01), Sawhney et al.
patent: 6161541 (2000-12-01), Woodson
patent: 0 706 808 (1996-04-01), None
Hoffstein et al, Reduction in Snoring with Phosphocholinamin, a Long Acting Tissue-Lubricating Agent, 1987, Am J Otolaryngol, Jul.-Aug.; 8(4): 236-40.*
LaFrentz, J.R.L. et al., “Palatal stiffening techniques for snoring in a novel canine model”,ARO Abstracts, vol. 22, Abstrct No. 499, pp. 125-126 (Feb. 13-18, 1999).
C. Lorenz, “If he Snores—what can you do about it?”, Today's Woman, Jul. 1948, p. 112.
Dalmasso, F. et al., “Snoring: analysis, measurement, clinical implications and applications”,Eur Respir J., vol. 9, pp. 146-159 (1996).
Harries, P.G., et al, “Review Article: The surgical treatment of snoring”,The Journal of Laryngology and Otology, vol. 110, pp. 1105-1106 (Dec. 1996).
Huang, L. et al. “Biomechanics of snoring”,Endeavour, vol. 19, No. 3, pp. 96-100 (1995).
Schwartz, R. et al., “Effects of electrical stimulation to the soft palate on snoring and obstructive sleep apnea”,The Journal of Prosthetic Dentistry, vol. 76, No. 3, pp. 273-281 (Sep. 1996).
Brochure, “What causes Snoring?”,Minneapolis Otolaryngology, 2 pgs.
Brochure, “Our Diagnostic Procedures are a Snap!®”,Snap Laboratories, 4 pgs.
Brochure, “Snoreless™”,Nutrition For Life International, 2 pgs. (Dec. 1999).
Brochure, “Snore-Free Nights-Guaranteed!”,Your Health News, 2 pgs.
U.S. application Ser. No. 09/513,432, filed Feb. 25, 2000.
Brenzel Michael P.
Zhao Hugh Qinghong
McCrosky David
Merchant & Gould P.C.
Pi Medical, Inc.
Winakur Eric F.
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