Patent Application
20070068534
The present invention relates to mandibular advancement devices, or oral appliance devices, used to minimize airflow restrictions during sleep. These devices commonly treat orthodontic conditions, bruxism, snoring, Obstructive Sleep Apnea (“OSA”), other sleep breathing disorders and temporomandibular joint disorders. More specifically, the present invention relates to a combination bite jig, mouthpiece and acoustic pharyngometer capable of quickly and objectively maximizing airflow patency.
Certain sleep breathing disorders, including OSA and snoring, occur as a result of airway obstruction. Mandibular advancement devices force the lower jaw forward and downward. The repositioning of the mandible pulls the tongue forward and thereby decreases upper airway obstruction.
Mandibular advancement devices come in numerous forms. Moldable mouthpieces, similar to dental protective devices worn by athletes, exist to retain the lower jaw in a forward position during sleep. One such example is set forth in U.S. Pat. No. 5,462,066. This and similar moldable mouthpieces offer a one-time custom fit and retain the lower jaw in a static position during sleep.
Mandibular advancement devices utilizing moldable mouthpieces, however, suffer from several problems. In addition to taking time to create, such devices are often tough to create properly, especially for a first time user. Often the resulting mold is too loose. This can be due to, for example, a failure to apply the proper suction or a failure to heat the device to the proper molding temperature during creation. Although the user can sometimes correct such an improper mold creation by a second heating and forming attempt, after two attempts such devices are often incapable of creating a proper fit. Even if properly created, these devices lack adjustability.
User adjustable mandibular advancement devices also exist. U.S. Pat. No. 5,570,704, for example, discloses a user adjustable oral cavity device designed to reduce snoring and other sleep breathing disorders. The device includes a means by which the user can adjust the degree of separation between the maxilla and mandible. The device also includes a means by which the user can adjust the degree to which the mandible is moved forward.
Other mandibular advancement devices allow for lateral excursion of the mandible relative to the upper jaw. U.S. Pat. No. 5,868,138 discloses such a device. The lateral movement relieves discomfort to the tempromandibular joint, related muscles and ligaments exacerbated by laterally fixed devices for users that have a tendency to grind their teeth during sleep.
Some mandibular advancement devices, such as the one disclosed by U.S. Pat. No. 5,611,355, are both moldable and adjustable. In the '355 patent, the upper and lower members mold to the users teeth. Once molded, these members fasten together using an adjustable fastening mechanism, such as hook-and-loop fasteners, permitting the lower member to be gradually moved forward over a period of days or weeks.
U.S. Pat. No. 6,055,986 discloses a mandibular advancement device incorporating and combining many of the features of the aforementioned devices. Specifically, the '986 patent discloses an oral apparatus including moldable upper and lower members adjustably attached. The attachment means allows for both forward and lateral freedom of movement of the mandible.
Other oral appliances decrease upper airway obstruction by repositioning the user's tongue. Like mandibular advancement devices, these oral appliances help to normalize breathing during sleep thus relieving snoring and OSA. An example is seen in U.S. Pat. No. 6,675,804. There, a semi-spherical multi-lobed structure positions the user's tongue. In addition to this tongue positioning structure, this oral appliance includes a flanged lip plate and a dome-shaped outer shield.
Several problems exit when using these devices. The degree of adjustability in these devices is limited. Additionally, even when these devices are adjustable, they are often cumbersome to adjust and contain numerous separate interrelated moving parts. As such, they are subject to breakage. Furthermore, optimization of settings remains difficult if not impossible. For prior art devices, the mandibular advancement or other oral appliance device settings are determined by combining trial and error with patient feedback. The user or physician is left to guess at the optimal settings. The inability to precisely optimize the settings, such that the particular oral appliance device results in the largest upper airway opening possible, leaves users with, at best, incomplete or partial relief.
Pharyngometers and other wavetube-based devices are known in the art. U.S. Pat. No. 5,666,960, incorporated herein by reference, is an example. Acoustic Pharyngometers graphically depict airway patency by using acoustic signaling processing technology. An acoustic signal is generated by a probe position in the mouth and subsequently recorded by microphones. An acoustic reflectometer plots a cross-sectional area of the airway as a function of distance from the airway opening by measuring the amplitudes and arrival times of the acoustic signals. These devices typically comprise a mouthpiece, wavetube, speaker, microphone, acoustic device, filter strips, CPU, printer, monitor, P.C. board, software and source code. Typically these devices have various electronic components affixed to the wavetube. These devices provide fast, objective analysis of airway obstruction and give the physician concrete data with which to make adjustments in the patient's oral appliance or mandibular advancement device.
While Pharyngometers and other wavetube-based devices provide objective data on a patient's airway obstruction, these devices are not designed to be used in connection with a particular oral appliance or mandibular advancement device. As a result, the objectively obtained data does not translate into an optimum setting for a particular oral appliance.
The present invention is designed to overcome the aforementioned problems. Specifically, the present invention is directed to an oral appliance device, of durable construction, capable of precise mandibular adjustment while adapted to being used in conjunction with a mouthpiece and acoustic Pharyngometer. This arrangement allows for the simultaneous, or near simultaneous, airflow capacity measurement and mandibular adjustment.
It is therefore an object of the invention to provide an apparatus for maximizing airway patency comprising a bite jig; a mouthpiece; and, an acoustic pharyngometer.
Further object of the invention will be achieved by a the specific bite jig configuration including a handle, a center section adapted to receive user's front teeth, an arch support member and at least one arch, disposed between the arch support member and the user's teeth.
A further object of the invention is provide a mouthpiece adaptable to be connected to an acoustic Pharyngometer including an arched flange and a lumen, wherein the lumen includes ridges adapted to receive a connection to an acoustic Pharyngometer.
Still further objects of the invention will be achieved by a tongue guide affixed to the bite jig and by connecting an adjustable tongue guide to the bite jig.
Still further objects of the invention will be achieved by providing a plurality of protuberances on the bite jig handle.
Other objects of the invention will be achieved by providing a center section of the bite jig that includes at least one upper cutout, adapted to receive at least one upper tooth of the user.
Other objects of the invention will be achieved by providing a center section of the bite jig that includes at least one lower cutout, adapted to receive at least one lower tooth.
Further objects and advantages of the invention will become apparent from the following description and claims and from the accompanying drawings wherein:
Turning now more particularly to the drawings,
In this embodiment of the present invention there are a total of two arches. These arches, 3a and 3b, are shown in
Center section 5 also includes a plurality of lower cutouts 7. When the user bites down on the bite jig the lower front teeth or lower incisors enter into and will be held by any one of the lower cutouts 7. As such, these cutouts operate to hold the position of the lower mandible. The lower cutouts 7 are evenly spaced to guide the movement of the lower jaw forward. The lower cutouts 7 are positioned to allow for normal closure of jaws and a gradual advancement of lower jaw.
In this embodiment of the present invention handle 1, center section 5, and arch support piece 4 are a single unitary construction manufactured out of a semi-rigid material. This construction and material allow for a secure positioning of the lower jaw. The thickness of this unitary construction can vary. For example, the degree of oral cavity opening will be dictated by the thickness of center section 5 and support piece 4. As such, in different embodiments, the bite jig is provided in various thicknesses at center section 5 and along support piece 4, where the user's teeth are positioned. The present invention envisages numerous types of thickness variation. A substantially uniform thickness throughout section 5 and support piece 4 could be incrementally increased in successive embodiments. And in other embodiments the thickness could vary throughout section 5 and support piece 4, forming, for example, a wedge shape. These different embodiments allow for adjustment of the user's bite registration and further allows for testing to aid in setting of various changes in incisal openings.
Turning now to
The bite jig is designed for use in conjunction with a mouthpiece or acoustic sealing flange. An embodiment of such a mouthpiece can be seen in
Mouthpiece 20 also includes internal ridges 13 formed on the inside of lumen 12. In other embodiments the ridges are on the outside of lumen 12. These ridges aid in connecting the mouthpiece to a Pharyngometer. Specifically, the mouthpiece 20 is connected to the Pharyngometer wave tube. The ridges allow for ease of coupling and uncoupling the mouthpiece to the Pharyngometer wave tube, while maintaining a stable connection during the testing process.
In operation, the present invention allows for the near simultaneous measuring of airflow capacity and mandibular advancement device adjustment. The physician first places the bit-jig into the users mouth. The user bites down on the bite jig. Here, the mandible is adjusted to an initial position. The mouthpiece is then placed into the users mouth. As seen most clearly in
With this apparatus, the physician is then able to test the user's airway patency. After receiving objective data from the Pharyngometer, the physician can easily and quickly adjust the advancement of the user's mandible without removing or disconnecting the Pharyngometer. This allows for the precise and simultaneous, or near simultaneous, measuring of airflow patency and mandibular adjustment.
