ORAL DEVICE FOR MANDIBULAR ADVANCEMENT AND MEDIAL TONGUE CONSTRAINT

Abstract

An oral device for temporary placement in a patient's oral cavity includes upper and lower jaw braces and a tongue-engaging member. The upper and lower jaw braces are connected so that the lower jaw brace is advanced in an anterior direction relative to the upper jaw brace when the upper and lower jaw braces are closed together. A partial vacuum is drawn in the oral cavity and the vacuum and lower jaw displacement together control the position of the tongue in order to clear the patient's airway to reduce sleep apnea or treat other conditions.

Claims

1. An oral device for temporary placement in a patient's oral cavity, said device comprising: an upper jaw brace; a lower jaw brace; and a vacuum source which is connectable to the oral device; wherein the upper jaw brace and the lower jaw brace are configured to be connected to one another such that so that the lower jaw brace is advanced in an anterior direction relative to the upper jaw brace.

2. An oral device as in claim 1, wherein the upper and lower jaw braces each comprise a U shaped bite plate configured to be positioned against a full dentition.

3. An oral device as in claim 1, wherein the upper jaw brace and the lower jaw brace are connected by a pair of rigid links, wherein each link is pivotally attached at one end to the upper brace and at another end to the lower brace to allow the braces to open and close.

4. An oral device as in claim 1, wherein the lower jaw brace is configured to be advanced relative to the upper jaw brace by a distance in a range from 4 mm to 12 mm when the upper and lower jaw braces are closed together.

5. An oral device as in claim 1, wherein the vacuum source is adapted to draw a vacuum in a range from 1 cm H2O to 100 cm H2O through the oral device.

6. An oral device as in claim 1, wherein the tongue-engaging member is connectable to a vacuum line and a bleed line to allow a continuous air flow therethrough while maintaining a partial vacuum in the oral cavity.

7. A method for maintaining an open airway in a patient having an oral cavity, a tongue, and a palate, said method comprising: engaging an upper jaw brace against upper teeth of a patient; engaging a lower jaw brace against lower teeth of the patient; and applying a vacuum within the oral cavity to draw together the soft palate and a posterior region of the tongue; and engaging the upper and lower jaw braces with one another so that the lower jaw brace moves in an anterior direction relative to the upper jaw brace when the jaws are closed together.

8. A method as in claim 7, wherein the lower jaw brace is advanced relative to the upper jaw brace by a distance in a range from 4 mm to 12 mm when the upper and lower jaw braces are closed together.

9. A method as in claim 7, wherein the upper jaw brace and the lower jaw brace are connected by a pair of rigid links, wherein each link is pivotally attached at one end to the upper brace and at another end to the lower brace to allow the braces to open and close.

10. A method as in claim 7, wherein the upper jaw brace and the lower jaw brace are fixedly attached to each other.

11. A method as in claim 7, wherein the vacuum in the oral cavity draws the soft palate against a posterior surface of the member.

12. A method as in claim 11, wherein the soft palate remains spaced-apart from the posterior surface of the member while the vacuum in the oral cavity is being applied.

13. A method as in claim 11, wherein the vacuum in the oral cavity is in a range from 25 cm H2O to 50 cm H2O.

14. A method as in claim 11, wherein applying the vacuum in the oral cavity comprises continuously drawing a vacuum while simultaneously bleeding in a controlled amount of air to maintain a desired partial vacuum.

15.-39. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 illustrates the relevant anatomy of the nasal and oral cavities.

[0021] FIG. 2 illustrates the relevant anatomy of the nasal and oral cavities with an oral device of the present invention in place.

[0022] FIGS. 3A and 3B illustrate an embodiment of an oral device constructed in accordance with the principles of the present invention with FIG. 3A providing an anterior to posterior perspective view and FIG. 3B showing an posterior to anterior perspective view.

[0023] FIGS. 4A and 4B are schematic side views of the oral device of FIGS. 3A and 3B shown with upper and lower jaw braces closed together with the lower brace advanced in an anterior direction relative to the upper brace in FIG. 3A and the with the upper and lower braces opened in FIG. 3B.

[0024] FIG. 5 is a side view of an alternative embodiment of the oral device of the present invention having upper and lower jaw braces permanently affixed to each other.

[0025] FIGS. 6A-6E are top, oblique, front and side cross-sectional views, respectively of an oral device according to the invention in a further embodiment thereof, in which the lip seal is removed for clarity.

[0026] FIGS. 7A and 7B illustrate an embodiment of an oral device constructed in accordance with the principles of the present invention with FIG. 7A providing an anterior to posterior perspective view and FIG. 7B showing a posterior to anterior perspective view.

[0027] FIGS. 8A and 8B are schematic side views of the oral device of FIGS. 8A and 8B shown with upper and lower jaw braces closed together with the lower brace advanced in an anterior direction relative to the upper brace in FIG. 8A and with the upper and lower braces opened in FIG. 8B.

DETAILED DESCRIPTION OF THE INVENTION

[0028] Referring to FIG. 1, the anatomy of the oral and nasal cavities relevant to obstructive sleep apnea (OSA) and the placement of the devices of the present invention will be described. The upper teeth UT of the patient are anchored in the hard palate HP, and the lower teeth LT are anchored in the lower jaw or mandible LJ. The soft palate SP extends in a rearward or posterior and inferior direction from the hard palate, and together the hard palate and soft palate divide the nasal airway NA from the oral cavity OC. The lower extent of the oral cavity is largely defined by the upper surface of the tongue T in this view, and it will be appreciated that both the soft palate SP and the tongue are mobile structures capable of movement between the positions shown in full line and broken line in FIG. 1. A nasal airway NA extends inferiorly into the pharynx P which defines the airway generally behind the soft palate SP and the tongue T. The regions on the tongue and soft palate shown with a heavy dashed line are the areas responsible for the gag reflex GR.

[0029] Obstructive sleep apnea occurs when the soft palate, the tongue or both move in a posterior direction so that they contact the rear or posterior surface of the pharynx P. The posterior motion of the soft palate and/or tongue may also reduce the size of the airway without contacting the pharynx P causing a partial blockage. The temporary blockage of the airway behind the soft palate and tongue will cause the disrupted breathing pattern characteristic of OSA and usually associated with snoring.

[0030] As used herein, “superior” refers to the direction toward the top of the oral cavity (or top of the head), “inferior” refers to the direction opposite the superior direction, “anterior” refers to the direction toward the front of the oral cavity or lips, and “posterior” refers to the direction toward the back of the oral cavity and airway, opposite the anterior direction. The terms “patency” and “airway” refer to the opening or clearing of the airway leading from the nasal cavity into the trachea located generally behind the soft palate and the rear of the tongue. To improve airway patency, the airway may be wholly or partially obstructed intermittently or temporarily for some time period over a normal sleep cycle, however, the airway will be open or partially open more than it would in the patient's untreated condition. The “upper portion of the soft palate” refers to the superior portion of the soft palate extending inferiorly from the end which connects to the hard palate to a point about one-third to one-half way toward the free inferior tip of the soft palate. The phrase “medial region” or “medial surface” of the tongue refers to a superior surface of the tongue which is spaced substantially posteriorly from the anterior tip of the patient's tongue and immediately anterior or forward of the region which initiates the gag reflex. While it may vary from patient to patient, the medial region will generally be the middle one third of the upper surface of the tongue which extends between the anterior tip of the tongue and the posterior end of the tongue (the posterior end being the location on the tongue that is furthest posterior in the oral cavity); i.e., the medial surface will usually include an area of the tongue that is at least about one-third of the way, more preferably at least about one-half of the way, from the anterior tip of the tongue to the posterior end of the tongue. Preferably, the medial region will include an area on the tongue posterior to the midpoint between the anterior and posterior ends of the hard palate. The phrase “clear region” refers to the space or volume above and/or posterior of the tongue which will be cleared by the methods and devices of the present invention. The clearing will usually be achieved by engaging a surface which is inclined forwardly relative to a plane of the brace when the brace is positioned between the upper and lower teeth and against the superior surface of the tongue, typically using a member or element which engages the tongue and which is anchored within the oral cavity so as to simultaneously advance the tongue in an anterior direction and depress the tongue in an inferior direction to open or maintain the clear region and allow the negative pressure to draw the soft palate against the tongue. The term “vacuum” and the phrase “negative pressure” each refers to a total or partial vacuum which is maintained in the clear region, typically by controlled aspiration, where the pressure is maintained primarily in the range from 5 cm H.sub.2O to 150 cm H.sub.2O below the local atmospheric pressure. The “occlusal plane” is the plane in which the upper and lower teeth meet when the patient bites the upper and lower teeth together.

[0031] Referring now to FIG. 2, use of an oral device 10 comprising an upper jaw brace 12, a lower jaw brace 14, and a tongue-engaging member 16 in performing the methods of the present invention will be described generally. Oral device 10 is placed in the patient's oral cavity OC by the patient. The upper jaw brace 12 is placed over the upper teeth UT and the lower brace is placed over the lower teeth LT. When the patient's jaws are generally closed together, the upper jaw brace 12 and lower jaw brace 14 will be brought together so that occlusal surfaces of the braces will be generally in direct contact with each other, and the tongue-engaging member 16 will be positioned over the medial region of the tongue helping raise the tongue within the oral cavity OC and pushing the tongue forward away from the patient's airway. By simultaneously applying a vacuum in the oral cavity, typically through ports formed on the tongue-engaging member (but optionally formed elsewhere on the oral device 10), the patient's soft palate SP will be drawn forwardly in an anterior direction as indicated by arrow A in FIG. 2, further clearing the patient's airway.

[0032] Referring now to FIGS. 3A and 3B, the upper jaw brace 12 and lower jaw brace 14 of the exemplary oral device 10 can be joined together by links 18A and 18B, one on each side of the device. The links may be rigid and fixedly secured to the upper jaw brace 12 and lower jaw brace 14, for example by screws as illustrated in FIGS. 3A and 3B. The lengths of such fixed links can be adjustable, e.g. being formed as a telescoping structure that can be locked in a desired therapeutic position. Additionally, the links 18 may be attached to the upper and lower jaw braces, respectively, by pivoting attachments. When the attachments are pivoting, it will be possible for the patient to at least partially open and close his or her jaws while maintaining the jaw braces on the teeth. Such movement of the jaws, however, will be difficult unless the links 18A and 18B are also capable of elongating to provide the necessary freedom for the jaw to open and close. In cases where the upper and lower jaw braces are fixed, of course, the patient will not be able to open and close his or her jaws while wearing the braces. In other cases, the upper jaw brace 12 and the lower jaw brace 14 can be attached using elastic bands 78A, 78B attached to anchors 74 on the braces 12, 14 as shown in FIGS. 7A and 7B.

[0033] The tongue-engaging member 16 will typically have one or more vacuum ports 20 formed on a posterior surface thereof. These vacuum ports 20 are connected to a vacuum source 22 by a pair of vacuum lines 24. A partial vacuum may be maintained within the patient's oral cavity using the vacuum source 22. Usually, a vacuum line 24A while an air bleed is connected to the tongue-engaging member by line 24B. By controlling the vacuum and air bleeds provided through lines 24A and 24B, respectively, the vacuum source can maintain a target vacuum within the oral cavity in the ranges set forth above. Suitable vacuum control systems are described in the commonly owned patents and pending patent application incorporated by reference hereinabove.

[0034] Side views of the oral device 10 are shown in FIGS. 4A and 4B. In 4A, the upper jaw brace 12 is closed downwardly against the lower jaw brace 14 in a configuration in which the device 10 will generally be worn to inhibit snoring and sleep apnea. A particular advantage of the construction of device 10, however, is that should the patient need to open his or her mouth, the links 18A and 18B (only 18A shown in FIGS. 4A and 4B), can pivot and extend to allow the patient to open his or her mouth without dislodging the braces from his or her teeth. When closed, however, the upper brace will again extend anteriorly relative to the lower brace, as shown in FIG. 4A. In other cases, where the upper and lower braces 12, 14 are attached using elastic bands 78A, 78B, the bands 78A, 78B and anchors 74 are arranged to pull the lower jaw forward as shown in FIGS. 8A and 8B.

[0035] In an alternative configuration, as shown in FIG. 5, the upper jaw brace 12 and the lower jaw brace 14 may be permanently affixed so that they cannot be opened and closed relative to each other. For example, the components may be molded or formed as an integrated or monolithic structure. Alternatively, the jaw braces may be glued, heat sealed, or otherwise attached together, for example using permanent screws.

[0036] Still another embodiment of an oral device according to the invention is illustrated in FIGS. 6A-E. In this embodiment, oral device 310 has a bite structure 311 and a tongue constraint 312 comprising a plate 313 with a soft palate landing pad 314. Landing pad 314 has a posterior edge 315 with an arcuate shape that curves outwardly in the posterior and (optionally) inferior directions beyond the open end of bite structure 311. With this shape landing pad 314 may be more suitably located to engage the soft palate in some patients. In addition, landing pad 314 optionally includes a plurality of ribs 318 extending laterally across landing pad 314. Ribs 318 stand in relief on the posterior surface 316 of landing pad 314 to enhance engagement with the soft palate tissue, as well as help to channel the vacuum flow laterally. Ribs 318 may comprise tubular, round, or partially-round strips affixed to landing pad 314, or ribs 318 may be integrally formed with landing pad 314. Ribs may also be provided along the superior surface of plate 313 oriented either laterally like ribs 318 illustrated, in the anterior-posterior direction, or in other orientations.

[0037] The vacuum tube 320 extends past apex A to a point near the posterior edge 315 of oral device 310. In this way, vacuum tube 320 ensures that negative pressure is applied along the posterior edge of oral device 310, a location closer to the soft palate. Vacuum tube 320 includes side holes 322 and an open distal end 324 through which negative pressure may be applied. Additionally, in this embodiment, tongue constraint 312 has no vacuum ports extending through plate 313 as in the earlier embodiment.

[0038] Another unique aspect of oral device 310 is the placement of spacing elements 324 on the inferior surface 326 of bite structure 311. Spacing elements 324 are a soft pliable material, e.g. polymeric tubing or foam, having a thickness of about 2-12 mm. Each spacing elements 324 is positioned at or near a posterior end 329 of bite structure 311 and extends anteriorly approximately 25-75% of the way around to the front of bite structure 311. Alternatively, multiple spacing elements of shorter length may be placed at intervals along each side of bite structure 31. In this way spacing elements 325 sit between the patient's upper and lower teeth and hold open the lower jaw slightly. Such slight opening of the jaw during sleep has been shown to improve airway patency in some circumstances.

[0039] A further unique aspect of oral device 310 is that a jaw positioning tab 328 is disposed on the anterior closed end of bite structure 311 and extends downwardly therefrom sufficiently to engage the posterior surface of the lower front teeth when oral device 310 is positioned in the oral cavity. Jaw positioning tab 328 is of sufficient stiffness and positioned in a suitable location on bite structure 311 to maintain the patient's lower jaw in a position slightly forward of a normal relaxed position. Such forward positioning of the jaw has been found to improve airway patency in some circumstances.

[0040] It should be understood that ribs 318, spacing element 324, and jaw positioning tab 328 are optional features of oral device 310 and that any or both of these features may be eliminated without departing from the scope of the invention or limiting its utility.

[0041] It will be understood that oral device 310 will usually include a lip seal. It should be further understood that any or all of the features of oral device 310 may optionally be included in oral device 10 or in other embodiments described herein.

[0042] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.