Surgery – Body protecting or restraining devices for patients or infants – Antisnoring device
Reexamination Certificate
2001-04-30
2004-06-15
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Antisnoring device
C602S902000, C128S898000
Reexamination Certificate
active
06748950
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates to compositions, materials and methods for the treatment of snoring.
2. Description of Related Art
Monomer and polymer adhesives are used in both industrial (including household) and medical applications. Included among these adhesives are the 1,1-disubstituted ethylene monomers and polymers, such as the &agr;-cyanoacrylates. Since the discovery of the adhesive properties of such monomers and polymers, they have found wide use due to the speed with which they cure, the strength of the resulting bond formed, and their relative ease of use. These characteristics have made the &agr;-cyanoacrylate adhesives the primary choice for numerous applications such as bonding plastics, rubbers, glass, metals, wood, and, more recently, biological tissues.
It is known that monomeric forms of &agr;-cyanoacrylates are extremely reactive, polymerizing rapidly in the presence of even minute amounts of an initiator, including moisture present in the air or on moist surfaces such as animal (including human) tissue. Monomers of &agr;-cyanoacrylates are anionically polymerizable or free radical polymerizable, or polymerizable by zwitterions or ion pairs to form polymers. Once polymerization has been initiated, the cure rate can be very rapid.
Medical applications of 1,1-disubstituted ethylene adhesive compositions include use as an alternate or an adjunct to surgical sutures and/or staples in wound closure, as well as for covering and protecting surface wounds such as lacerations, abrasions, burns, stomatitis, sores, minor cuts and scrapes, and other wounds. When an adhesive is applied to surfaces to be joined, it is usually applied in its monomeric form, and the resultant polymerization gives rise to the desired adhesive bond.
U.S. Pat. Nos. 5,514,371, 5,514,372, 5,575,997, 5,624,669, and 5,582,834 to Leung et al. disclose the addition of a therapeutic agent in a cyanoacrylate composition. The cyanoacrylate adhesive forms a matrix for the therapeutic agent, with the therapeutic agent being released in vivo over time from the matrix during biodegradation of the polymer.
Despite the widespread use of cyanoacrylate adhesives for medical and industrial purposes, to date, cyanoacrylate adhesives have not been used to treat patients suffering from snoring. Excessive snoring affects nearly 20% of all adults, and nearly 50% of adults over the age of 60 are chronic snorers. Snoring is caused by a variety of factors including, but not limited to, lack of exercise, obesity, alcohol consumption and smoking. Generally, snoring is due to airway obstruction. As a result, minor snoring is caused by minimal airway obstruction. Similarly, more severe snoring, at its worst, can be caused by complete airway obstruction which can lead to obstructive sleep apnea syndrome (OSAS). Individuals who suffer from OSAS experience excessive airway obstruction that can lead to sleep fragmentation and even excessive daytime sleepiness (EDS).
Physicians often treat minor snoring by recommending that patients take simple measures such as increasing exercise, losing weight, decreasing alcohol consumption, reducing smoking, altering sleeping position, and using dental or nasal appliances. Although these relatively simple measures can be somewhat effective, many patients do not experience satisfactory relief from snoring. As a result, for many patients the only alternative is surgery.
Several surgical methods have been developed to reduce snoring. Among the various known methods, the most common methods involve surgical procedures performed to the palate, the rectopalatal pharynx, retrolingual pharynx, and the nasal passages. Generally, palatal surgical procedures are the least invasive and most widely used surgical procedures.
One of the earliest surgical procedures developed, which is still in use today, is uvulopalatopharygoplasty (UPPP). This procedure was developed in 1961 and was first introduced in the United States in 1981 to treat OSAS, and later to treat snoring in general. In this procedure a physician performs a tonsillectomy, and then partially removes the soft palate and pharyngeal arches. Finally, the mucosal edges are approximated with sutures. The objective of this procedure is to reduce snoring by providing additional room for airflow and reducing the amount of vibratory tissue.
Although UPPP is initially 75 to 100% effective in eliminating or at least reducing snoring, the long term success rates of UPPP are not as promising. More specifically, studies show that 13% of patients who have “successful” outcomes develop a recurrence of snoring within a period of one year from the date of the surgery. Overall, studies indicate that only 46% of patients report complete prevention or significant reduction of snoring over time.
In addition to the poor success rates of UPPP, various complications can also occur as a result of the procedure. The most serious complication is a 2 to 11% incidence of postoperative airway obstruction resulting in a 1% perioperative mortality. In addition, 2 to 5% of patients experience serious postoperative bleeding that requires the patients to return for further medical treatment. Many patients also report severe postoperative pain. In one study, of 86% of patients who reported a successful outcome, only 60% of those patients indicated that they would be willing to undergo the same treatment despite the resulting postoperative pain.
The most common long-term complications associated with UPPP include velopharyngeal incompetence (VPI) and palatal dryness. Most patients experience at least temporary postoperative VPI. In addition, 10 to 24% of patients report intermittent nasopharyngeal regurgitation one year after surgery. In similar studies, up to 31% of patients reported persistent palatal dryness. Less frequent long-term complications can include nasopharyngeal stenosis, long-term voice changes and partial loss of taste.
In addition to the many drawbacks associated with UPPP, UPPP is also an expensive procedure. Although the cost of the procedure can vary significantly, generally the procedure, the anesthesia and one night of postoperative observation in an intensive care unit can exceed $10,000.
In view of the obvious disadvantages of UPPP, efforts were made to develop a more effective, safer and more economical procedure. These efforts resulted in the development of laser-assisted uvuloplataplasty (LAUP). This procedure, originally referred to as laser vaporization of the palatapharynx, is similar to conventional UPPP except that it does not involve the removal of the tonsils. In addition, LAUP differs from convention UPPP because it is performed in several stages using only local anesthesia.
The most popular LAUP procedure is performed using a CO
2
laser having a special backstop attachment to make vertical incisions on both sides of the uvula. These incisions form trenches that extend 1 to 2 cm from the free edge of velum. The uvulum is then significantly shortened. The entire procedure is performed under local anesthesia and is repeated within 4 to 6 weeks as needed.
Initially, the results of LAUP were promising. Short term success rates were reported to be between 70 and 97%. However, as with UPPP, LAUP patients also suffered from a decrease in long-term efficiency. A study of the long-term effectiveness of LAUP showed that at 18 to 24 months following the procedure only 55% of patients reported that their bed partner was satisfied with the results of the procedure.
However, when compared with UPPP, LAUP is less invasive because it involves less palatal resection, and does not require removal of a patient's tonsils. In addition, the procedures can be performed using only local anesthesia. These differences can result in fewer postoperative complications, including postoperative bleeding and airway obstruction. In addition, by reducing the amount of palatal resection, LAUP can also reduce the likelihood of long-term complications such as VPI and voice changes.
Despite the reduction in postoperative comp
Clark Jeffrey G.
Sherbondy Anthony J.
Brown Michael A.
Closure Medical Corporation
Oliff & Berridg,e PLC
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