Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-09-29
2003-10-21
Jastrzab, Jeffrey R. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C128S848000, C600S380000, C607S134000
Reexamination Certificate
active
06636767
ABSTRACT:
BACKGROUND
1. Field of the Invention
This invention is directed to method and apparatus 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
, Vol. 19, No. 3, pp. 96-100 (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). 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.
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. Alternatively, these devices must be used during the day for a period of time causing disruption of daily activity, interference with daily life. This may generally be assumed to cause them to be prone to a significant risk of non-compliance by the wearer. Such devices, though have met with some success in treating disorders such as snoring and Obstructive Sleep Apnea.
SUMMARY OF THE INVENTION
According to a preferred embodiment of the present invention, a method and apparatus are disclosed for treating snoring of a patient. The invention includes implanting a stimulating electrode into a patient. The electrode is placed in stimulating contact with an airway passage-controlling muscle of the patient. The electrode is energized to contract the muscle and alter the airway passage.
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Cole, P. et al., “Snoring: A Review and a Reassessment”,The Journal of Otolaryngology, vol. 24, No. 5, pp. 303-306 (1995).
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Schwartz, R. et al., “Effects of Electrical Stimualation to the Soft Palate on Snoring and Obstructive Sleep Apnea”,TheJournal of Prosthetic Dentistry, vol. 76, No. 3, pp. 273-281 (Sep. 1996).
Wiltfant, J. 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 and Maxillofacial Surgery, pp. 21-25 (1999).
Boot, H. et al., “Long-Term Results of Uvulopalatopharyngoplasty for Obstructive Sleep Apnea Syndrome”,The Laryngoscope, pp. 469-475 (Mar. 2000).
Coleman, S. et al., “Midline Radiofrequency Tissue Reduction of the Palate for Bothersome Snoring and Sleep—Disordered Breathing: A Clinical Trail”,Otolaryngology—Head and Neck Surgery, pp. 387-394 (Mar. 2000).
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Kasey, K. et al., “Radiofrequency Volumetric Reduction of the Palate: And Extended Follow-Up Study”,Otolaryngology—Head and Neck Surgery, vol. 122, No. 3, pp. 410-414 (Mar. 2000).
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Conrad Timothy R.
Knudson Mark B.
Nickoloff Robert S.
Jastrzab Jeffrey R.
Oropeza Frances P.
Restore Medical Inc.
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