Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
1999-08-24
2001-02-06
Buiz, Michael (Department: 3731)
Surgery
Instruments
Internal pressure applicator
Reexamination Certificate
active
06183493
ABSTRACT:
BACKGROUND
1. Field of the Invention
This invention relates to a method and apparatus for treating nasal-oropharyngeal obstructions, sleep apnea, and related breathing disorders. More particularly, this invention relates to an improved method and a device for maintaining nasal-oropharyngeal airway patency.
2. Description of the Related Art
Sleep apnea is a sleep-related breathing disorder that is thought to affect between 1-10% of the adult population. Recent epidemiologic data indicate that 2% of women and 4% of men between the ages of 30 and 60 years meet the minimum diagnostic criteria for sleep apnea syndrome, representing more than 10 million individuals in the United States. It is a disorder with significant morbidity and mortality, contributing to increased risk of hypertension, cardiac arrhythmias, stroke, and cardiovascular death. Current treatments include nasal continuous positive airway pressure (“CPAP”), bi-level positive airway pressure (“BiPAP”), surgery, and other treatments. However, while CPAP and BiPAP are effective, up to 50% of patients discontinue treatment due to inconvenience and discomfort.
Sleep apnea is characterized by multiple respiratory pauses during sleep. These pauses, or apneas, are defined as the complete cessation of airflow in nasal and oral airways lasting at least 10 seconds. Partial reductions in airflow, known as hypopneas, are defined as the reduction of airflow in the nasal and oral airways lasting at least 10 seconds. Apneas and hypopneas result from the complete or partial obstruction of the upper airway, and can cause oxygen desaturation, arousal from sleep, or both. Any condition that interferes with airway patency can contribute to or result in the occurrence of such events. Therefore, the maintenance of upper airway patency is the primary goal of treatment of patients with sleep apnea. Upper airway patency can conveniently be achieved by maintaining nasal-oropharyngeal airway patency.
One common method for treating sleep apnea is the use of nasal continuous positive airway pressure (“CPAP”) as disclosed in U.S. Pat. No. 5,065,756. Nasal CPAP is administered by means of a mechanical device that delivers pressurized room air to the nasal passage, or airway, through a nose mask that is worn by the patient. This device helps to maintain upper airway patency by means of a “pneumatic splint.” (Sullivan et al., 1981, Lancet, 1, 882-865; Sanders, 1983, Chest, 83, 144-145). However, compliance with, and long-term acceptance of, this treatment are poor. Studies have shown that between 20% and 50% of patients fail to use nasal CPAP as prescribed (Sanders, et al., 1986, Chest, 90, 330-333; Krieger & Kurtz, 1988, Europ. Respira. J., 1, 436-438; Kribbs, et al., 1993, Am Rev. Respir. Dis., 147, 887-895).
Other treatments for sleep apnea include the use of a tongue retaining device and other oral appliances (Lowe, 1994, Principles and Practice of Sleep Medicine, Philadelphia, Suanders), and surgical procedures such as uvulopalatopharyngoplasty (UPPP) and laser-assisted uvulopalatopharyngoplasty (LAUP) (Fujita, 1981, Otolaryngo. Head Neck Surg., 89, 923-934; Kamami, 1990, Acta Otorhino-laryngol Belgica, 44, 451-456). However, the efficacy of these treatments is generally poor, with significant improvement achieved in fewer than ⅓ of the patients treated.
The failure of current therapies to provide effective and tolerable treatment for sleep apnea has led to consideration of novel devices. It has been suggested that sleep apnea can be treated with the use of a nasopharyngeal tube (Nahnias & Karetzky, 1988, Chest, 94, 1142 1147; Afzelius, et al., 1981, Laryngoscope, 91, 285-291). Nasopharyngeal tube therapy has resulted in a reduction in apneas and hypopneas, decreased stage I (light) sleep, increased rapid-eye-movement (REM) sleep, and subjective improvement in daytime sleepiness.
While the apparatuses described in the prior art, for example, U.S. Pat. No. 5,664,567 and U.S. Pat. No. 4,821,715 are nasopharyngeal tubes that can be inserted into the airways of patients with sleep apnea, these devices were designed to be inserted by a physician, not a patient. These tubes are difficult to insert and are not appropriate for nightly use at home by the patient. It is desirable to further refine the method and apparatus to provide an effective, convenient, and tolerable treatment for sleep apnea.
Therefore, a need still exists for an improved upper airway patency device having greater acceptance among patients that is effective, and that may be easily inserted by patients.
SUMMARY OF THE INVENTION
This invention relates to a method and device for treating nasal-oropharyngeal obstructions, sleep apnea, and related breathing disorders. In one embodiment of the present invention, the device comprises a collapsible nasal-oropharyngeal tube made from a resilient semi-rigid plastic, for example, a hypoallergenic plastic such as PVC or polyurethane. The device is collapsed to facilitate insertion, and is held in its collapsed state by a restraint such as, for example, a tie or clasp. The patient inserts the collapsed device into the upper airway until the device's distal end is located near the pharynx, and optionally beyond the soft palate, while the proximate end is located near the nostril opening. A lubricating anaesthetic may be applied to the device to ease insertion. Once the device is inserted, the patient releases the restraint to expand the device. The expanded tubular device maintains nasal passage patency, and the device's lumen maintains an unobstructed airway from the nostril to the oropharynx.
The device's proximate and distal ends can be flared or flanged to facilitate the device's correct positioning in the patient, to reduce airflow turbulence around the around the oropharynx, and to reduce the risk of airway collapse.
Therefore it is an object of the present invention to provide a tubular device, or nasal-oropharyngeal tube that is collapsible, and so can be inserted more easily through a patient's nasal passage either by the patient, or by medical staff.
Another object of the present invention is to provide a nasal-oropharyngeal tube that causes minimal irritation, discomfort, and ulceration during insertion and use.
Still another object of the present invention is to provide a self-administered treatment for sleep apnea that may be a highly desirable alternative to CPAP, BiPAP, surgery, or other treatments.
Another object of the present invention is to provide a nasal-oropharyngeal tube that may be used as an interface to nasal CPAP.
Yet another object of the present invention is to provide a nasal-oropharyngeal tube that is an effective, convenient, and comfortable treatment of nasal passage obstructions and sleep apnea.
In addition to treating sleep apnea, an airway patency device that is easily inserted into the upper airway has many other uses. It may be used by patients with sleep-related breathing disorders other than sleep apnea, such as snoring or upper airway resistance syndrome. It may be used by medical staff, for example, by anesthesiologists requiring an alternative to traditional nasopharyngeal tubes. It also may be used as an interface to nasal CPAP, replacing the need for nasal CPAP masks, such as the apparatus disclosed in U.S. Pat. No. 4,655,213.
Other features and advantages of the invention will be apparent from the following description of embodiments thereof and from the claims.
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Buiz Michael
Morgan & Finnegan L.L.P.
Pharmasys International, LLC
Truong Kevin
LandOfFree
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