Motion limiting device

Details Motion limiting device Motion limiting device

1998-02-18

2002-03-19

Pothier, Denise (Department: 3733)

Surgery

Body protecting or restraining devices for patients or infants

Antisnoring device

C602S902000

Reexamination Certificate

active

06357444

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to the field of devices used to limit the range of motion of a sleeping patient.
BACKGROUND OF THE INVENTION
A good night of sleep is very important to a person's overall health and ability to function in a normal capacity throughout the day. Snoring and obstructive sleep apnea (OSA) are common respiratory obstructive sleep disorders which can significantly affect an individual's quality of sleep as well as the sleep of others. Snoring is very common in the adult population, in that it affects approximately 40% of all adults by the age of 50. Typically, people do not hear themselves snore, but snoring noise can disrupt the sleep of others around them. This can put a strain on family or social relationships and can also be a source of embarrassment for the person who is snoring.
Obstructive sleep apnea (“OSA”) is a condition in which there is a complete, or near-complete, obstruction to airflow during sleep. OSA is a significant health problem which is associated with high blood pressure, heart problems and stroke. The most common symptoms associated with OSA are loud snoring and excessive daytime drowsiness. This significant daytime drowsiness can result in difficulty staying awake during meetings or conversation, reading, watching television or, more importantly, while driving. Although the majority of snorers do not have OSA, it is estimated that two-percent of women and four-percent of men in the middle-aged work force have OSA.
The snoring noise is typically produced by vibration of the soft palate and uvula against the back of the throat or the base of the tongue. This usually occurs as a person falls asleep, and these soft tissues, the tongue, and the muscles in the throat area relax. As the tongue relaxes, it will drop back, causing a narrowing of the upper airway. When a person breathes in through a narrower airway, the air moves faster and will cause the tissues to vibrate and the snoring to occur. An apnea event occurs when there is a collapse of the soft tissues in the upper airway which leads to a blockage in airflow of at least ten seconds duration. This cessation in airflow can have a significant physiologic impact on the body, especially the cardiovascular system. The apnea event is usually terminated by a loud snort as the airway re-opens and is associated with a brief awakening, called an arousal, which occurs at the end of the apnea event. These arousals significantly disrupt the sleep of the individual, and can lead to tiredness and fatigue during the day.
It is well known that sleeping in the supine position exacerbates snoring and obstructive sleep apnea. It is common for a bed partner to nudge the snorer with an elbow or foot and instruct the snorer to roll on their side, which will indeed eliminate or greatly reduce the snoring. In addition, research studies have documented that 60% of all patients diagnosed with OSA have a position-dependent OSA. These patients have a dramatic increase in the frequency of apnea events when sleeping in the supine position, versus the side or prone positions. Therefore, sleep position is a significant contributing factor for many patients with sleep-disordered breathing conditions.
The current treatment alternatives for managing snoring and OSA are focused on maintaining the patency of the airway by various means. These treatments include:
Nasal Continuous Positive Airway Pressure (nasal CPAP)—This employs a tight-fitting mask which is attached to a blower that will blow room air under pressure through the nasal passage. This positive airway pressure acts as a pneumatic splint to prevent collapse of the upper airway.
Surgical treatments for management of OSA are designed to correct anatomical abnormalities that lead to airway obstruction, especially in patients with disproportionate anatomy of the nose, maxilla and/or mandible, or the soft tissues of the upper airway. These surgical procedures include nasal reconstruction, uvulopalatopharyngoplasty (UPPP), and various maxillary/mandibular surgical procedures.
Oral appliance therapy involves a treatment program which uses a device worn over the teeth to advance the mandible or tongue in order to increase the size and improve the patency of the airway.
Behavioral therapies are an important part of the overall treatment program for managing snoring and OSA. These adjunctive treatments include managing health and lifestyle conditions such as obesity, alcohol or benzodiazepine consumption, body position, sleep posture, and nasal congestion. These treatments may be used alone or in conjunction with other medical or dental treatment.
The negative impact of sleeping in the supine position is well documented in the research literature; however, treatment of this factor has been largely overlooked by health care providers who are managing snoring and OSA. The current treatments used to prevent patients from sleeping on their backs include use of a tennis ball sewn into the back of the pajamas, placing pillows around body to maintain position, or a gravity-sensitive alarm. Problems with these options make it necessary to consider alternative treatment such as the anti-snoring cushion. The problem with the tennis ball sewn into the pajamas is that the patients are able to roll partially onto their backs and some obese patients are not kept off their backs by the tennis ball. If the individual does roll onto the tennis ball, it will tend to disrupt their sleep by causing them to partially or completely wake. Some patients feel that it is too much of an inconvenience to sew the tennis ball into place. Use of pillows to maintain a certain body position is difficult because the pillows tend to shift or move, during the night, allowing the patient to roll into the supine or unfavorable position. The difficulty with the gravity-sensitive alarm is that it causes the patient to arouse out of deeper sleep or wake completely when the alarm sounds. This leads to disruption of the patient's sleep.
In addition to preventing a patient from sleeping in the supine position to prevent snoring and obstructive sleep apnea, sometimes it is necessary to limit the patient's ability to sleep in certain positions so as to isolate and keep pressure off certain portions of the body. For example, after major surgery, such as a hip or knee joint replacement or shoulder surgery, it is necessary to isolate and keep pressure off that portion of the body to help it to recover properly. Other surgeries also require that a portion of the body be isolated. Unlike preventing one from rolling over into a supine position, with a major surgery it is imperative that the patient isolate these portions of the body for proper recovery. Immediately after surgery of this type, patients are asked to sleep in a partially reclined position, usually in a reclining chair, or a large foam wedge about half of the patient's body length is placed on the bed to prevent the patient from rolling into the surgical site. However, this large foam wedge is uncomfortable to sleep against and it can shift or move during the night. Presently, there is a trend to release patients from the hospital quickly so that the overall cost of health care can be reduced. In order to allow an earlier release, a device is needed which can be used easily at home by a patient to limit the motion during rest or sleep.
There are several problems associated with the pads and systems currently in use. First of all, the shape of the pads does not necessarily prevent a patient from rolling over the pads. Most pads project out from the patient a short distance. These thinner, shorter pads can still allow the patient to roll into a partially supine position in which the torso is at an angle of 20° to 45° to the bed. In this position the head and neck are almost fully supine and the airway can still become fully or partially obstructed. The pads produce discomfort, should a patient roll atop the pad, but they would not prevent one from rolling onto a certain part of the body. Obese patients ma

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