Surgery – Miscellaneous
Reexamination Certificate
2002-04-11
2003-06-17
Lacyk, John P. (Department: 3736)
Surgery
Miscellaneous
C128S848000
Reexamination Certificate
active
06578580
ABSTRACT:
BACKGROUND
1. Field of the Invention
This invention is directed to methods and apparatuses for treating 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. Such devices are appliances requiring patient adherence to a regimen of use as well as subjecting the patient to discomfort during sleep. Electrical stimulation to treat sleep apnea is discussed in Wiltfang, et al., “First results on daytime submandibular electrostimulation of suprahyoidal muscles to prevent night-time hypopharyngeal collapse in obstructive sleep apnea syndrome”,
International Journal of Oral
&
Maxillofacial Surgery
, pp. 21-25 (1999).
Surgical treatments have been employed. One such treatment is uvulopalatopharyngoplasty. 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. Uvulopalatopharyngoplasty (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. Assessment of snoring treatment is discussed in Cole, et al., “Snoring: A review and a Reassessment”,
Journal of Otolaryngology
, pp. 303-306 (1995).
Huang, et al., supra, describe the soft palate and palatal snoring as an oscillating system which responds to airflow over the soft palate. Resulting flutter of the soft palate (rapidly opening and closing air passages) is a dynamic response generating sounds associated with snoring. Huang, et al., propose an alternative to uvulopalatopharyngoplasty. The proposal includes using a surgical laser to create scar tissue on the surface of the soft palate. The scar is to reduce flexibility of the soft palate to reduce palatal flutter. Huang, et al., report initial results of complete or near-complete reduction in snoring and reduced side effects.
Surgical procedures such as uvulopalatopharyngoplasty and those proposed by Huang, et al., continue to have problems. The area of surgical treatment (i.e., removal of palatal tissue or scarring of palatal tissue) may be more than is necessary to treat the patient's condition. Surgical lasers are expensive. The proposed procedures are painful with drawn out and uncomfortable healing periods. The procedures have complications and side effects and variable efficacy (e.g., Huang, et al., report promising results in 75% of patients suggesting a full quarter of patients are not effectively treated after painful surgery). The procedures may involve lasting discomfort. For example, scar tissue on the soft palate may present a continuing irritant to the patient. Importantly, the procedures are not reversible in the event they happen to induce adverse side effects not justified by the benefits of the surgery.
SUMMARY OF THE INVENTION
According to one aspect of the present invention, methods and apparatuses are disclosed for treating snoring of a patient. The invention includes an implant of biocompatible material sized to be embedded within the soft palate. The implant is disposed within a bore of a distal tip of a needle for penetration into the soft palate. The bore is sized to receive a rod from a proximal end of the needle with the rod opposing the implant to eject the implant from the distal tip upon relative sliding movement of said needle and said rod. The needle at the distal tip is perforated for fluid to flow through a wall of the needle into engagement with the implant. The implant is selected to altering a dynamic response of the soft palate to airflow past the soft palate.
REFERENCES:
patent: 3998209 (1976-12-01), Macvaugh
patent: 4830008 (1989-05-01), Meer
patent: 4978323 (1990-12-01), Freedman
patent: 5046512 (1991-09-01), Murchie
patent: 5052409 (1991-10-01), Tepper
patent: 5133354 (1992-07-01), Kallok
patent: 5176618 (1993-01-01), Freedman
patent: 5178156 (1993-01-01), Takishima et al.
patent: 5190053 (1993-03-01), Meer
patent: 5281219 (1994-01-01), Kallok
patent: 5284161 (1994-02-01), Karell
patent: 5456662 (1995-10-01), Edwards et al.
patent: 5514131 (1996-05-01), Edwards et al.
patent: 5540733 (1996-07-01), Testerman et al.
patent: 5591216 (1997-01-01), Testerman et al.
patent: 5674191 (1997-10-01), Edwards et al.
patent: 5718702 (1998-02-01), Edwards
patent: 5792067 (1998-08-01), Karell
patent: 5843021 (1998-12-01), Edwards et al.
patent: RE36120 (1999-03-01), Karell
patent: 5897579 (1999-04-01), Sanders
patent: 5922006 (1999-07-01), Sugerman
patent: 6098629 (2000-08-01), Johnson et al.
patent: 38 30 481 (1990-03-01), None
patent: 200 15 980 (2001-03-01), None
patent: 0 292 936 (1988-11-01), None
patent: 0 706 808 (1996-04-01), None
patent: 1553140 (1990-03-01), None
patent: WO 00/59398 (2000-10-01), None
Boot, H. et al., “Long-Term Results of Uvulopalatopharyngoplasty for Obstructive Sleep Apnea Syndrome”,The Laryngoscope, pp. 469-475 (Mar. 2000).
Cole, P. et al., “Snoring: A Review and a Reassessment”,The Journal of Otolaryngology, vol. 24, No. 5, pp. 303-306 (1995).
Coleman, S. et al., “Midline Radiofrequency Tissue Reduction of the Palate for Bothersome Snoring and Sleep-Disordered Breathing: A Clincal Trial”,Otolaryngology—Head and Neck Surgery, pp. 387-394 (Mar. 2000).
Dalmasso, F. et al., “Snoring: analysis, measurement, clinical implications and applications”,Eur. Respir. J., vol. 9, pp. 146-159 (1996).
Du, G. et al., “Geometric Modeling of 3-D Braided Preforms for Composites”, Textile Structural Composites Symposium, Drexel Laboratory, Philadelphia, Pennsylvania, 25 pages (1991).
Ko, F., “Braiding”,Engineered Materials Handbook, vol. 1,Composites, T.J. Reinhart, Editor, ASM International, Metals Park, Ohio, pp. 519-528 (Nov. 1987).
Ellis, P. D. M. et al., “Surgical relief of snoring due to palatal flutter: a preliminary report”,Annals of the Royal College of Surgeons of England, vol. 75, No. 4, pp. 286-290 (1993).
Fischer, Y. et al., “Die Radiofrequenzablation des weichen Gaumens (Somnoplastik)”,Redaktion, pp. 33-40 (2000).
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., “Flutter of Cantilevered Plates in Axial Flow”,Journal of Fluids and Structures, vol. 9, pp. 127-147 (1995).
Huang, L. et al., “Biomechanics of snoring”,Endeavour, vol. 19, No. 3, pp. 96-100 (1995).
Kasey, K. et al., “Radiofrequency Volumetric Reduction of the Palate: An Extended Follow-Up Study”,Otolaryngology-H
Conrad Timothy R.
Knudson Mark B.
Lacyk John P.
Merchant & Gould P.C.
Restore Medical Inc.
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