Oral interface and method using the same

This invention provides an oral interface mainly including a connecting channel, a collapsible chamber and a non-collapsible structure disposed inside the collapsible chamber. The connecting channel communicates between the collapsible chamber and a negative source. When a negative pressure environment is generated inside the collapsible chamber via being pumped by the negative pressure source, the non-collapsible structure supports the collapsible chamber so that there are fluid channels formed inside the collapsible chamber. The air inside a user's oral cavity can be pumped out via the fluid channels and the connecting channel. A negative pressure environment is hence formed inside the user's oral cavity.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to medical devices and methods that may prevent or reduce symptoms of obstructive sleep apnea (OSA). In particular, the present invention relates to a negative pressure oral interface device to be placed in the oral cavity of a patient.

Description of the Prior Art

Obstructive sleep apnea (OSA) is a condition in which repeated collapses in the patient's airway during inhalation causes a cessation of breathing during sleep. During inhalation, air pressure in the lungs and respiratory passages is reduced. If during this time, the tone of the muscles in the upper-airway is reduced, the airway tends to collapse. As the airway begins to occlude prior to an apnea episode, the patient often begins to snore. Snoring is an effort to try to combat the collapsed airway. These obstructions occur in different locations along the respiratory pathway in different patients, but the two common locations are the oropharynx or the nasopharynx.

People with moderate to severe OSA experience daytime sleepiness, fatigue, and poor concentration. In addition to these immediate problems, research has shown that patients with OSA use more medical resources, have an increased risk of medical disability, and finally have a higher mortality rate. Patients with severe OSA are estimated to have a three to six fold increased risk of mortality considering all causes. OSA is also implicated in many cardiovascular conditions, such as systemic hypertension and some degree of pulmonary hypertension. It is associated with an increased risk for myocardial infarction, cerebrovascular disease, and cardiac arrhythmia. OSA causes excessive daytime sleepiness due to interrupted sleeping pattern at night which leads to inability to concentrate. Patients' daily functions are impaired as their neuro-cognitive function is compromised. They are more likely to make errors and run into accidents. Therefore, OSA is a significant medical condition with serious negative outcomes if left untreated.

There are several current treatment options for OSA patients. Oral interfaces are used to treat mild OSA, but they often don't work well and cause damage to gums and teeth. Several types of surgery are used to treat OSA, however, surgical options are invasive, expensive and painful with recovery periods up to 6 months. The most common treatment for moderate to severe sleep apnea in adults is CPAP, which has 96% market share in OSA therapeutics. A CPAP machine consists of a mask, a pump and a humidifier. The device continuously blows pressurized air into the patient's nose to keep the airway open during sleep. CPAP is quite effective; however, it has unpleasant side effects such as dry throat and nose congestion. Patients who use CPAP often feel bloated in the morning and experience headaches. The machine is noisy and uncomfortable for the user and their partner. CPAP is currently the first-line and gold standard treatment, but it suffers low compliance due to significant side effects.

It has been proposed to apply a negative pressure to the patient's oral cavity to pull the tongue and soft palate forward to maintain the patency of the airway, as an improvement over CPAP, for example, U.S. Pat. No. 5,957,133, U.S. Patent and Patent Publication Nos. 2005/0166928, and 2006/0096600. While promising in theory, these prior arts comprise relatively large structures to engage the teeth and/or to retain the tongue. These approaches tend to occupy a lot of space in the oral cavity, which may cause discomfort and damage to large area of teeth, gum, and soft tissues. At the same time, the presence of such larger devices may induce excess saliva secretion and elicit the gag reflex. The other major disadvantage of these approaches is that the oral devices are anatomically dependent, requiring special technicians to customize the interface for each individual patient.

SUMMARY OF THE INVENTION

According to the above, an object of the present invention is to provide alternative and improved oral interface devices and methods of use for treatment of obstructive sleep apnea or snoring. Another object of the present invention is to provide small oral interface devices and methods to minimize the clear space within the oral cavity. Still another object of the present invention is to provide comfortable, convenient, and compact oral interface devices and methods of use that may be easy to implement and can effectively maintain the patient's airway patency during sleep.

The present invention provides oral interface devices and methods of use for reducing or treating snoring or obstructive sleep apnea by applying negative pressure in oral cavity via a small oral interface. The negative pressure pulls the tongue toward the upper palate and pulls the soft palate forward. By moving both the tongue and the soft palate forward, the airway patency near the oropharynx can be maintained to prevent disordered breathing during sleep. The negative pressure also pull the lips inward to close the mouth, thus preventing air from the outside entering the oral cavity. The negative pressure further pulls the soft palate toward the rear surface of the tongue to create a closed area to prevent air entering the oral cavity through the nasal passages.

The present invention provides an oral interface device which comprises a connecting tube with one end connecting to a negative pressure source, a collapsible chamber having upper and lower walls and first and second open longitudinal ends, the upper and lower walls each having an exterior surface and an interior surface, wherein the first longitudinal end of the collapsible chamber is fluidly connected to the second longitudinal end of the connecting tube, and non-collapsible structures disposed between the interior surfaces of the upper and lower walls of the collapsible chamber. The non-collapsible structures having lengths extending longitudinally along the collapsible chamber and are spaced apart from one another such that the interior surfaces of the upper and lower walls of the collapsible chamber and the non-collapsible structures define a fluid channel extending longitudinally along the collapsible chamber. The fluid channel fluidly connects the second open longitudinal end of the collapsible chamber and the second longitudinal end of the connecting tube. Further aspects of the present invention include an oral interface device where the non-collapsible structures are disposed between the upper and lower walls of the collapsible chamber, the non-collapsible structures being spaced longitudinally inward from the second open longitudinal end of the collapsible chamber and spaced longitudinally inward from the first open longitudinal end of the collapsible chamber, and the non-collapsible structures being disposed inward of side edges of the upper and lower walls of the collapsible chamber. When a negative pressure environment is generated by the negative pressure source in the collapsible chamber, soft tissue in the oral cavity leans upon the collapsible chamber, then compresses and collapses the collapsible chamber. The non-collapsible structure supports the collapsible chamber and maintains internal fluid passages inside the collapsible chamber in a collapsed condition, thus keeps fluid communication between the oral cavity and the negative pressure source. When the tissue in the oral cavity is moved by a patient or involuntarily, the collapsible chamber may resume its original volume. The resuming process of the collapsible chamber causes self-generated vacuum effect due to increasing volume, which increases the force to pull back the tissue or to prevent the tissue from movement.

In another aspect, the present invention provides methods to generate negative pressure in a user's oral cavity in order to stabilize oral soft tissue. The method can employ the above-mentioned or other oral interface devices to achieve similar effect in stabilizing oral soft tissues. The method comprises the following steps: placing an oral interface device in the oral cavity and positioning a collapsible chamber of the oral interface device at anterior portion (a half or a third) of a tongue and middle region of the upper dental arch; extending a connecting tube of the oral interface device connected to the collapsible chamber from the mouth to negative pressure source outside of the oral cavity; adjusting the connecting tube of the oral interface device to a proper position, preferably moving the connecting tube to one of the biting opening of canine teeth; activating the negative pressure source with the lips closed tightly. Air within the user's oral cavity is evacuated via the internal fluid passages inside the collapsible chamber and the connecting tube. A negative pressure environment is maintained in the use's oral cavity, and at the same time, soft tissues in the oral cavity lean on the collapsible chamber, compress, and collapse the collapsible chamber, therefore, to minimize the clear space or space occupied by the oral interface device within the oral cavity.

Additionally, the oral interface device may be placed at one of the following places: a location between the user's tongue and hard palate, a location between the user's tongue and lower jaw, a location between teeth and lips, a location between an outside surface of teeth and a lateral wall inside the oral cavity, or a location between the user's tongue and soft palate.

Methods of the present invention may further contain, using a non-collapsible structure to support the collapsible chamber, so that the collapsible chamber can preserve internal fluid passages after being collapsed, in order to keep the negative pressure source connected to the oral cavity. Methods of the present invention may still further contain, using a gripping structure on one external wall of the collapsible chamber, so that the gripping structure can press up against and grip the soft tissues in the user's oral cavity after the collapsible chamber being collapsed, in order to stabilize soft tissues. Methods of the present invention may still further contain, using an adhesive patch to attach to the user's lips, in order to prevent users from involuntary opening his mouth, thus maintaining oral negative pressure environment.

The above-mentioned devices and methods require only partial evacuation time of the negative pressure source, which are more energy-saving and quieter. The oral interface devices of the present invention are also more compliant to the shape of the oral tissues, more comfortable, and taking less space inside the mouth.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The object, spirit, and advantages of the preferred embodiments of the present invention will be readily understood by the accompanying detailed descriptions and drawings.

FIGS. 1A and 1Bshow perspective and front views, respectively, of an oral interface device according to the first embodiment of the present invention. In the first embodiment, an oral interface100comprises a connecting tube110, with one end connecting to a negative pressure source (not shown); a collapsible chamber120, with one end connecting to the other end of the connecting tube110in relative to the negative pressure source; an open end140on another end of the collapsible chamber120; a non-collapsible structure130, for example, comprising a rib, disposed on at least one internal wall of the collapsible chamber120. Referring toFIG. 1B, the non-collapsible structure130has a width W2smaller than an internal width W1of the collapsible chamber120. The non-collapsible structure130has a height H2smaller than an internal height H1of the collapsible chamber120.

FIG. 2AtoFIG. 2Eshow different views of the oral interface100in use. Referring toFIGS. 2A to 2C, the collapsible chamber120of the oral interface100is placed at anterior region (a half or a third) of the tongue and middle region of the upper dental arch. The position and orientation of the oral interface100can be adjusted properly, for example, the connecting tube110can be moved its position to the biting positioning of the left or right canine teeth, as shown inFIGS. 2A and 2C, or the connecting tube110can be moved to the front teeth. Referring toFIG. 2B, the collapsible chamber120has an external width W3smaller than the width W4of the user's dental arch. Moreover, as shown inFIG. 2B, the collapsible chamber120of the oral interface100can be placed at anterior one half portion of the tongue, or preferably, anterior one third portion of the tongue. Therefore, the collapsible chamber120has an external length L1smaller than one half of the tongue length L2, or preferably, smaller than one third of the tongue length L2. Besides, as shown inFIG. 2D, the connecting tube110is moved to the biting position of the canine teeth, after the user closes the mouth, an adhesive patch150can be further attached to a proper position near the user's lips, for example, the corner of the mouth, to prevent the user from opening the mouth involuntarily, thus avoiding the oral interface100dropping out of the mouth. Besides, as shown inFIG. 2E, the oral interface100can further comprise an external shield member170, disposed between the collapsible chamber120and the connecting tube110. During usage of the oral interface100, the external shield member170can be attached to the user's mouth, in order to facilitate positioning and to limit moving of the oral interface100within the oral cavity, thus avoiding the oral interface100being swallowed or dropping out. Furthermore, the adhesive patch150can be attached to the external shield member170and upper and lower portion of the user's mouth.

FIGS. 3A and 3Bshow cross-sectional and front views of the oral interface100placed at the positions in user's oral cavity as shown inFIGS. 2A to 2Cwithout the negative pressure source activated, wherein large clear space with air resides between tongue and upper palate.FIGS. 3C and 3Dshow cross-sectional and front views of the oral interface100with the negative pressure source activated, wherein the air in the oral cavity is evacuated through the collapsible chamber120of the oral interface100to form a negative pressure environment. Soft tissue in the oral cavity leans upon the collapsible chamber120, then compresses and collapses the collapsible chamber120, as shown inFIG. 3E. The collapsible chamber120can have deformability, which is not only compliant to the shape of intraoral tissues such as the hard palate or the tongue, but also occupies less intraoral space and provides better comfortableness. The non-collapsible structure130can support the collapsible chamber120and maintain internal fluid passages inside the collapsible chamber120in a collapsed condition in the negative pressure environment, thus keeps fluid communication via fluid channels122between the oral cavity and the negative pressure source, as shown inFIG. 3E. When the tissue in the oral cavity is moved by a patient or involuntarily, the compressed collapsible chamber120may resume its original volume. The resuming process of the collapsible chamber120causes self-generated vacuum effect due to increasing volume, which increases the negative pressure and forces to pull back the tissue or to prevent the tissue from movement, as shown inFIG. 3D. The open end140of the collapsible chamber120provides fluidic communication of the oral cavity to the negative pressure source via the internal fluid passages of the collapsible chamber120and the connecting tube110. The negative pressure source evacuates air from the oral cavity, creates a negative pressure environment, and pulls the tongue, the soft palate and other soft tissues forward to maintain airway patency.

FIG. 4shows variations of the first embodiment of the present invention.FIG. 4Ashows a cross-sectional view of the first variation without negative pressure applied.FIGS. 4B to 4Dillustrate cross-sectional, top, and bottom view, respectively, of the first variation with negative pressure applied. The first variation of the present invention, an oral interface400, has a non-collapsible structure different from the oral interface100. The oral interface400has other equivalent parts the same as oral interface100, for example, an open end440, a connecting tube410, and a collapsible chamber420, etc., thus descriptions of which will not be repeated here. The oral interface400has a non-collapsible structure, which comprises a plurality of first ribs430and a plurality of second ribs430′. Each individual of the first ribs430can be parallel to each other and spaced apart on an internal wall of the collapsible chamber420. Each individual of the second ribs430′ can be parallel to each other and spaced apart on another internal wall, in relative to the first ribs430, of the collapsible chamber420. Besides, the first ribs430and the second ribs430′ can have a perpendicular or non-parallel stack configuration, as shown inFIGS. 4A to 4D. The non-collapsible structures of the present invention can be other non-rib protruding structures on the internal walls of the collapsible chamber, as shown in other variations of the first embodiment inFIGS. 4E to 4H. The other variations of the present invention, the oral interface401,402,403, or404, have a non-collapsible structure different from the oral interface400and the same other equivalent parts, for example, open ends441,442,443, or444, connecting tubes411,412,413, or414, and a collapsible chamber421,422,423, or424, etc., thus descriptions of which will not be repeated here. The second variation, as shown inFIG. 4E, has a non-collapsible structure431with circular protruding members on the internal wall of the collapsible chamber421. The third variation, as shown inFIG. 4F, has a non-collapsible structure432with square protruding members on the internal wall of the collapsible chamber422. The fourth variation, as shown inFIG. 4G, has a non-collapsible structure433with triangular protruding members on the internal wall of the collapsible chamber423. The fifth variation, as shown inFIG. 4H, has a non-collapsible structure434with cross-shaped protruding members on the internal wall of the collapsible chamber424. The second to fifth variations, the oral interface401,402,403, or404, of the first embodiment of the present invention have symmetrical or non-symmetrical non-collapsible structure431′,432′,433′, or434′ (not shown) on another internal wall of the collapsible chambers421,422,423, or424in relative to the non-collapsible structure431,432,433, or434. The non-collapsible structures can support the collapsible chambers421,422,423, or424when they collapsed in the negative pressure environment and maintain the internal flow passages within. The non-collapsible structures of the present invention can be any combination of the following different non-rib extruding structures' singular or plural permutations: circular, polygonal, cross-shaped or irregular-shaped.

FIG. 5shows the oral interface device according to the second embodiment of the present invention.FIGS. 5A to 5Eare the perspective, top cross-sectional, side cross-sectional, bottom cross-sectional, and front cross-sectional views, respectively, of the second embodiment. According to the second embodiment, an oral interface500of the present invention comprises a connecting tube510with one end connected to a negative pressure source (not shown), a collapsible chamber520with one end connecting to the connecting tube510in relative to the negative pressure, an open end540on another end of the collapsible chamber520, a non-collapsible structure530and530′ on two opposite internal walls of the collapsible chamber520, a first gripping structure550and a second gripping structure550′ disposed on the two opposite external walls of the collapsible chamber520. The non-collapsible structures,530and530′, comprise a plurality of first ribs530and a plurality of second ribs530′. Each individual of the first ribs530can be parallel to each other and spaced apart on an internal wall of the collapsible chamber520. Each individual of the second ribs530′ can be parallel to each other and spaced apart on another internal wall, in relative to the first ribs530, of the collapsible chamber520. Besides, the first ribs530and the second ribs530′ can have a perpendicular or non-parallel stack configuration. The first gripping structure550can comprise a plurality of concave holes on the top external wall of the collapsible chamber520, as shown inFIG. 5B. The second gripping structure550′ can comprise a plurality of concave holes on the bottom external wall of the collapsible chamber520, as shown inFIG. 5D. When the oral interface500is placed in a user's mouth and creates a negative pressure environment in the oral cavity by the negative pressure source, the first gripping structure550and the second gripping structure550′ can grip the soft tissue within the user's oral cavity to facilitate positioning of the collapsible chamber520. The oral interface500of the present invention can only have single side of the gripping structure550disposed on one external wall of the collapsible chamber520. When the oral interface500is placed in a user's mouth and creates a negative pressure environment in the oral cavity by the negative pressure source, the gripping structure550can grip the soft tissue within the user's oral cavity to facilitate positioning of the collapsible chamber520. The gripping structure550comprises plural concave holes can further be through-hole and connecting with the collapsible chamber520. The concave holes can distribute negative pressure from the negative pressure sources and the connecting tube510and increase forces of the gripping structure550to grip soft tissues in the oral cavity in order to positioning of the collapsible chamber520.FIG. 5FtoFIG. 5Kshow different variations of the oral interface device according to the second embodiment of the present invention.FIGS. 5F and 5Gshow cross-sectional and front views, respectively, of the first variation of the oral interface device placed in a user's oral cavity.FIGS. 5F and 5Gshow cross-sectional and front views, respectively, of the second variation of the oral interface device placed in a user's oral cavity.FIGS. 5H and 5Ishow cross-sectional and front views, respectively, of the second variation of the oral interface device placed in a user's oral cavity.FIGS. 5J and 5Kshow cross-sectional and front views, respectively, of the third variation of the oral interface device placed in a user's oral cavity. The difference between the first variation and the second embodiment of the oral interface device is that the oral interface device has an internal shield member5010and an external shield member5012. The internal and external shield members,5010and5012, can limit movement of the oral interface500and prevent the oral interface from being swallowed or dropping out. The other parts of the first variation are the same as the equivalent parts of the second embodiment, thus descriptions of which will not be repeated here. In the first variation, the oral interface device is preferably placed at anterior region (a half or a third) of the tongue and middle region of the upper dental arch. The user's lip can be held between the internal shield member5010and external shield member5012while the internal shield member5010is disposed between the teeth and the lip and the external member5012leans against external part of the mouth. The difference between the second variation and the second embodiment of the oral interface device is that the oral interface device has an internal shield member5014. The other parts of the second variation are the same as the equivalent parts of the second embodiment, thus descriptions of which will not be repeated here. In the second variation, the oral interface device is preferably placed at anterior region (a half or a third) of the tongue and middle region of the upper dental arch. The internal shield member5014is disposed between and leans against the teeth and the lip. The internal shield member5014can have a larger size that covers either upper and lower teeth or the mouth opening to keep mouth sealed (not shown). The difference between the third variation and the second embodiment of the oral interface device is that the oral interface device has an external shield member5016. The other parts of the third variation are the same as the equivalent parts of the second embodiment, thus descriptions of which will not be repeated here. In the third variation, the oral interface device is preferably placed at anterior region (a half or a third) of the tongue and middle region of the upper dental arch. The external shield member5016leans against external part of the mouth. The external shield member5016can have a larger size that covers the mouth opening to keep mouth sealed (not shown).

FIG. 6shows the fourth variation of an oral interface device according to the second embodiment of the present invention.FIGS. 6A and 6Bshow the cross-sectional view and the use scenario which the fourth variant of an oral interface device is put into a user's oral cavity with one end connected to a negative pressure source. In the second embodiment, an oral interface600comprises a connecting tube610, with one end connecting to a negative pressure source (not shown); a collapsible chamber620, with one end connecting to the other end of the connecting tube610in relative to the negative pressure source; an open end640on another end of the collapsible chamber620; a non-collapsible structure630, for example, comprised a plurality of parallel ribs spaced apart, disposed on top internal wall of the collapsible chamber620, and a first gripping structure650and a second gripping structure650′ disposed on top external wall and bottom external wall of the collapsible chamber620. The first gripping structure650and the second gripping structure650′ may comprise several recesses. Referring toFIG. 6B, when the vacuum applied to user's oral cavity, the tongue, soft palate, and other soft tissues are pulled forward to maintain airway patency, and the first gripping structure650and the second gripping structure650′ may grip the tongue, hard palate, and other soft tissues to facilitate positioning of the oral interface device600.

FIG. 7shows the fifth variation of an oral interface device according to the second embodiment of the present invention.FIGS. 7A and 78show the5cross-sectional view and the use scenario of an oral interface700of the fifth variation placing in a user's oral cavity connected to a negative pressure source. The oral interface700comprises a connecting tube710with one end connecting to a negative pressure source (not shown); a collapsible chamber720with one end connecting to the other end of the connecting tube710in relative to the negative10pressure source; an open end740on another end of the collapsible chamber720; a non-collapsible structure730, for example, comprised a plurality of parallel ribs spaced apart, disposed on top internal wall of the collapsible chamber720, and a first gripping structure750and a second gripping structure750′ disposed on top external wall and bottom external wall of the collapsible chamber720. In this manner, the first gripping structure750and second gripping structure750′ are disposed on the exterior surface of the top external wall and the exterior surface on the bottom external wall of the collapsible chamber720, as shown inFIG. 7A. The first15gripping structure750and the second gripping structure750′ may comprise several protrusions. Referring toFIG. 78, when the vacuum applied to user's oral cavity, the tongue, soft palate, and other soft tissues are pulled forward to maintain airway patency, and the first gripping structure750and the second gripping structure750′ may grip the tongue, hard palate, and other soft tissues to facilitate positioning of20the oral interface700.

FIG. 8shows the sixth variation of an oral interface device according to the second embodiment of the present invention.FIGS. 8A and 8Bshow the cross-sectional view and the use scenario of an oral interface of the sixth variation placing in a user's oral cavity connected to a negative pressure source. The oral interface800comprises a connecting tube810, with one end connecting to a negative pressure source (not shown); a collapsible chamber820, with one end connecting to the other end of the connecting tube810in relative to the negative pressure source; an open end840on another end of the collapsible chamber820; a non-collapsible structure830, for example, comprised of a plurality of parallel ribs spaced apart, disposed on top internal wall of the collapsible chamber820, and a first gripping structure850and a second gripping structure850′ on the top external wall and bottom external wall, respectively, of the collapsible chamber820. The first gripping structure850and the second gripping structure850′ are formed by recesses or sucker shaped concavities on the top external wall and bottom external wall of the collapsible chamber820. Referring toFIG. 8B, when the vacuum applied to a user's oral cavity, the tongue, soft palate, and other soft tissues are pulled forward to maintain airway patency, and the first gripping structure850and the second gripping structure850′ may grip the tongue, hard palate, and other soft tissues to facilitate positioning of the oral interface800. When oral tissues near the first gripping structure850and the second gripping structure850′ moves, the volume of spaces between the tissues and gripping structure850,850′ may increase, self-generated vacuum effect due to increasing volume increases the forces to pull back the tissue or to prevent the tissue from movement. The oral interface800of the present invention could only have a gripping structure850disposed on one-side of the external wall of the collapsible chamber820.

FIG. 9AtoFIG. 9Jshow various steps of a method for using the oral interface500according to the second embodiment of the present invention, for an example of methods of using the oral interface devices of the present invention. The methods of using the oral interface device of the present invention are not limited to this. Referring toFIG. 9A, to create vacuum in a user's oral cavity by using the oral interface500, first place the collapsible chamber520of the oral interface500into the user's oral cavity. Referring toFIG. 9B, adjust the position of the collapsible chamber520on the top of the user's tongue to a proper depth, for example, at about the one third of the total length of the tongue. If the distance from dorsal to tip of tongue is L, the length of the collapsible chamber520is preferably ⅓ L, and the collapsible chamber520is placed at the anterior surface of tongue within about ⅓ L length from the tip of the tongue. Referring toFIG. 9C, rotate the connecting tube510to a suitable orientation by using the collapsible chamber520as an axle center, for example, move the connecting tube510to the gap between the upper canine and lower canine teeth. Referring toFIG. 9D, let the user bite upper and lower rows of teeth gently. Referring toFIG. 9E, tear the oral strip (560,562) which comprises an adhesive patch560and a covering562. Referring toFIG. 9F, let the user close lips tightly. Referring toFIG. 9G, apply the adhesive patch560on a proper position between the upper and lower lips, for example, applying regions close to the corner of the mouth and above and below the lips in order to restrict the connecting tube510at the corner of the mouth and not moving around randomly, or aligning the center of the adhesive patch560with the centerline between upper and lower lips. Referring toFIG. 9H, attach the adhesive patch560tightly to regions above and below the user's lips to prevent user's mouth from opening involuntarily. Referring toFIG. 9I, connect the oral interface500to a negative pressure source (may comprise a liquid storage device590, a negative pressure connecting tube592, and a negative pressure generating device594) and activate the negative pressure source on to create a vacuum in the user's oral cavity. The liquid storage device590collects excessive secretions (such as saliva) from user's oral cavity to prevent the negative pressure generation device594from contaminated by the secretions.FIG. 9Jshows a cross-sectional view of the oral interface500connected with the negative pressure source. Under negative pressure environment, the tissues in the oral cavity may lean on the collapsible chamber520, compress and collapse the collapsible chamber520. The methods of the present invention employ a non-collapsible structure530to support the collapsible chamber520in order to maintain fluid passages when the collapsible chamber520is collapsed, which keeps the oral cavity in fluid communication with the negative pressure source. The methods of the present invention can further employ a gripping structure550on one of the external walls of the collapsible chamber520. When the collapsible chamber520is collapsed in the negative pressure environment, the gripping structure550may press up against and grip the soft tissues in the user's oral cavity to facilitate stabilizing of the soft tissue in the oral cavity.

FIG. 10shows an oral interface device according to the third embodiment of the present invention.FIG. 10AtoFIG. 10Cshow perspective, side and top views of the third embodiment, respectively. According to the third embodiment, an oral interface1000comprises a connecting tube1010with one end1015connecting to a negative pressure source (not shown), a collapsible chamber1020with one end connecting to the other end of the connecting tube1010in relative to the negative pressure source, an open end1040on another end of the collapsible chamber1020, a non-collapsible structure1030,1030′ on the two opposite internal walls of the collapsible chamber1020, a first gripping structure1050and a second gripping structure1050′ on two opposite external walls of the collapsible chamber1020, an internal shield member1060and the external shield member1070disposed between the collapsible chamber1000and connecting tube1010. The non-collapsible structure1030,1030′ is the same as the non-collapsible structure430,430′ inFIG. 4, which comprises a plurality of first ribs1030and a plurality of second ribs1030′. Each individual of the first ribs1030can be parallel to each other and spaced apart on an internal wall of the collapsible chamber1020. Each individual of the second ribs1030′ can be parallel to each other and spaced apart on another internal wall of the collapsible chamber1020. Besides, the first ribs1030and the second ribs1030′ can have a perpendicular or non-parallel stack configuration. The first gripping structure1050may comprise a plurality of recesses on the top external wall of the collapsible chamber1020, and the second gripping structure1050′ may comprise a plurality of recesses on the bottom external wall of the collapsible chamber1020.

FIG. 11AtoFIG. 11Eshows application diagrams and method of applying the oral interface1000of the third embodiment of the present invention.FIG. 11Ais a front view showing the first step of the method to place the collapsible chamber1020of the oral interface1000on a half or a third anterior portion of the tongue and middle region of the upper dental arch. The connecting tube1010is moved to the gap at the occlusive place of the upper and lower canine teeth.FIG. 11Bis a cross-sectional view which illustrates a present method to place the internal shield member1060of oral interface1000between the teeth and the lips and to place the external shield member1070outside of mouth. The internal and external shield member,1060and1070, jointly clamp tissues around a user's lips and facilitate securing the oral interface1000.FIG. 11Cis a front view which presents the current method by positioning the oral interface1000and then connecting negative pressure source (the liquid storage device1080, negative pressure connecting tube1082, the negative pressure generating device1084). The liquid storage device1080collects excess secretions (such as saliva) from the oral cavity and prevents the secretions contaminate the negative pressure generating device1084.FIG. 11Dis a cross-sectional view which illustrates a current method using the oral interface1000to create a negative pressure environment in the oral cavity of a user by the means of using the negative pressure source (1080,1082,1084). Under this negative pressure environment, the tissues in the oral cavity may lean against, compress and collapse the collapsible chamber1020. The first gripping structure1050and the second gripping structure1050′ may grip the soft tissues in the oral cavity of a user and facilitate stabilizing the soft tissues in the oral cavity.FIG. 11Eis a front view which shows the current method to attach the adhesive patch1090on the lips corner of a user after placing the oral interface1000in the oral cavity of a user, in order to prevent a user from opening involuntarily.

FIG. 12AtoFIG. 12Cshow perspective views of variations of the oral interface1000according to the third embodiment of the present invention.FIG. 13AtoFIG. 13Cshow front views of these variations in using status.FIG. 12Ais the first variation of the oral interface1000. The difference from the oral interface1000is that the first variation uses an adhesive patch1091and an external fixing part1071to replace the combination of internal shield member1060and the external shield member1070. The other parts of the first variation are the same as the equivalent parts of the third embodiment. The external fixing part1071is connected to the connecting tube1010. The adhesive patch1091can cover the extension member1071aof the external fixing part1071and then attach to regions above and below the lips. Therefore, the oral interface device of the first variation can be restricted within a fixed position (such as the corner of the mouth).FIG. 12Bshows the second variation of the oral interface1000. The difference between oral interface1000and the second variation is that the second variation uses an adhesive patch1092and an external fixing part1072to replace the combination of internal shield member1060and the external shield member1070. The other parts of the first variation are the same as the equivalent parts of the oral interface1000. The external fixing part1072is attached to the connecting tube1010. One edge of the adhesive patch1092has a circular notch1092a. Preferably, the size of circular notch1092ais larger or equal to the external size (like the external diameter) of the connecting tube1010but smaller than an external size of the external fixing part1072. The circular notch1092aencircles around the periphery of the connecting tube1010between the lips and the external fixing part1072. The adhesive patch1092attaches to regions above and below the lips. When the second variation of the oral interface device is placed in the oral cavity of a user, the adhesive patch1092can restrict the connecting tube1010from moving, as shown inFIG. 13B.FIG. 12Cshows the third variation of the oral interface1000. The difference between the oral interface1000and the second variation is that the second variation uses an adhesive patch1093and an internal shield member1063to replace the combination of internal shield member1060and the external shield member1070. The other parts of the first variation are the same as the equivalent parts of the oral interface1000. The internal shield member1063situates between the teeth and the lips of a user. One edge of the adhesive patch1093has a circular notch1093a. Preferably, the size of circular notch1093ais larger or equal to the external size (like the external diameter). The circular notch1093aencircles around the periphery of the connecting tube1010. The adhesive patch1093attaches to regions above and below the lips. When the third variation of the oral interface device is placed in the oral cavity of a user, the adhesive patch1093can prevent the connecting tube1010from moving, as shown inFIG. 13C.

FIG. 14Ashow an oral interface device according to the fourth embodiment of the present invention. According to the fourth embodiment, an oral interface1400of the present invention comprises a connecting tube1410with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber1420with one end in fluid communication with the other end of the connecting tube1410in relative to the negative pressure source, an open end1440on the other end of the collapsible chamber1420, a non-collapsible structure1430, for example, comprising at least a rib disposed on at least one internal wall of the collapsible chamber1420, an internal shield member1460formed at the open end1440on the collapsible chamber1420. When the oral interface1400is placed in a user's oral cavity, the collapsible chamber1420is placed between upper lip and lower lip, and the external width (not shown) of the collapsible chamber1420is smaller than the width of the user's mouth, and is preferably smaller than one half of the width of the user's mouth. The internal shield member1460is situated between the user's teeth and lips.FIG. 14Bshows an oral interface device according to the fifth embodiment of the present invention. According to the fifth embodiment, an oral interface1401of the present invention comprises a connecting tube1411with one end connecting to a negative pressure source (not shown); a collapsible chamber1421with one end connecting to the other end of the connecting tube1411in relative to the negative pressure source, an open end1441on another end of the collapsible chamber1421, a non-collapsible structure1431, for example, comprising of at least a rib disposed on at least one internal wall of the collapsible chamber1421, and an external shield member1470disposed between the collapsible chamber1421and the connecting tube1411. When the oral interface1401is applied in a user's oral cavity, the collapsible chamber1421is placed between the user's upper lip and lower lip, and the external shield member1470leans on the outside surface of the user's mouth.FIG. 14Cshows an oral interface device according to the sixth embodiment of the present invention. According to the sixth embodiment, an oral interface1402of the present invention comprises a connecting tube1412with one end connecting to a negative pressure source (not shown); a collapsible chamber1422with one end connecting to the other end of the connecting tube1412in relative to the negative pressure source, an open end1442on another end of the collapsible chamber1422, a non-collapsible structure1432, for example, comprising of at least a rib disposed on at least one internal wall of the collapsible chamber1422, an internal shield member1462disposed at the open end1442on the collapsible chamber1422, and an external shield member1472disposed between the collapsible chamber1422and the connecting tube1412. When the oral interface1402is applied in a user's oral cavity, the internal shield member1462and the external shield member1472may clamp the user's upper and lower lips together, and the collapsible chamber1422is placed between the user's upper lip and lower lip.

FIG. 15andFIG. 16show the first and second variations of the oral interface1400according to the fourth embodiment of the present invention.FIGS. 15A to 15Dare perspective, top, side, and front views of the first variation, respectively. In the first variation, an oral interface1500of the present invention comprises a connecting tube1510with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber1520with one end in fluid communication with the other end of the connecting tube1510in relative to the negative pressure source, an open end1540on the other end of the collapsible chamber1520, a non-collapsible structure comprising a plurality of first ribs1530and a plurality of second ribs1530′. Each individual of the first ribs1530can be parallel to each other and spaced apart on an internal wall of the collapsible chamber1520. Each individual of the second ribs1530′ can be parallel to each other and spaced apart on another internal wall of the collapsible chamber1520. Besides, the first ribs1530and the second ribs1530′ can have a perpendicular stack configuration. An internal shield member1560is disposed between the collapsible chamber1520and the open end1540. When placing the oral interface device in a user's oral cavity, the internal shield member is situated between the teeth and the lips of the user.FIG. 15shows a top view of the second variation. The difference between the first variation and the second variation is that internal shield member1561of the oral interface1501has a gripping structure comprising of a single or plural recesses1551on one surface facing the user's teeth. When applying the oral interface device with negative pressure source to create a negative pressure environment in the user's oral cavity, the recesses1551can grip the teeth or surrounding soft tissues to facilitate positioning of the collapsible chamber1521. The recesses1551may also enhance distribution of negative pressure to the oral cavity. The other parts of the oral interface1501, such as a connecting tube1511, a collapsible chamber1521with an open end1541, and non-collapsible structure (1531,1531′), are the same as the equivalent parts of the first variation, thus descriptions of which will not be repeated here.

FIG. 17AandFIG. 17Bshow the first variation of the oral interface1402according to the sixth embodiment of the present invention. The difference between the oral interface1700of the first variation and the oral interface1402is that the external shield member comprises reclosable fasteners (such as dual lock tape)1780,1780′ and a shield member1770. When using the oral interface1700, one side of the reclosable fasteners1780and1780′ are attached to regions above and below the user's lips and the shield member1770is attached to the other side of the reclosable fasteners1780,1780′ and leans against the outside surface of the user's mouth. The other parts of the oral interface1700, such as a connecting tube1710, a collapsible chamber1720with an open end1740, a non-collapsible structure1730and the internal shield member, are the same as the equivalent parts of the oral interface1402, thus descriptions of which will not be repeated here.

FIG. 17CtoFIG. 17Fshow the second to fifth variations of the sixth embodiment of the present invention, respectively. The difference of these variations with the oral interface1402is the structure of the external shield members, the other parts of the variations are the same as the equivalent parts of the oral interface1402, but not limit to it, for example, the non-collapsible structure of these variations can apply other types and shapes of above-mentioned embodiments, and these variations can also use other gripping structure described in the above-mentioned embodiments. In the second variation, the external shield member comprises reclosable fasteners1780,1780′ and a movable external shield1771which is cross-shaped and assembled with the collapsible chamber1720. In a use scenario of the oral interface1700, one side of the reclosable fasteners1780,1780′ are attached to regions above and below the user's lips and the shield member1771is attached to the other side of the reclosable fasteners1780,1780′ to facilitate closing of the user's mouth. The shield member1771can also temporarily detach from the reclosable fasteners1780,1780′ to allow the user to open mouth freely. In the third to fifth variations, the external shield members comprise reclosable fasteners1780,1780′ and movable external shields1772,1773, or1774, respectively with different shapes. In a use scenario of the oral interface1700, one side of the reclosable fasteners1780,1780′ are attached to regions above and below the user's lips and the shield members1772,1773, or1774are attached to the other side of the reclosable fasteners1780,1780′ to facilitate closing of the user's mouth. The shield members1772,1773, or1774can also temporarily detach from the reclosable fasteners1780,1780′ to allow the user to open mouth freely.

FIG. 18shows a side view of an oral interface device according to the seventh embodiment. According to the seventh embodiment of the present invention, an oral interface1800comprises a connecting tube1810with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber1820with one end in fluid communication with the other end of the connecting tube1810in relative to the negative pressure source, an open end1840on the other end of the collapsible chamber1820, a non-collapsible structure1830, for example, comprising at least a rib disposed on at least one internal walls of the collapsible chamber1820, an internal shield member at the open end1840of the collapsible chamber1820, and a first gripping structure and a second gripping structure. The first and second gripping structures comprise a plurality of protrusions1850,1850′ at the top and bottom external walls of the collapsible chamber1820, respectively. When the oral interface device is placed in a user's oral cavity, the internal shield member1860stays in between the teeth and the lips of the user. When a negative pressure environment is created in the user's oral cavity, the first and the second gripping structures can grip the user's upper and lower lips.

FIG. 19Ashows an oral interface device and method according to the eighth embodiment of the present invention. According to the eighth embodiment, an oral interface1900comprises a connecting tube1910with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber1920with one end in fluid communication with the other end of the connecting tube1910in relative to the negative pressure source, an open end1940on the other end of the collapsible chamber1920, a first griping structure and a second gripping structure formed by a plurality of protrusions1950and1950′ on top and bottom external walls of the collapsible chamber1902, respectively, an internal shield member1960disposed at the open end1940, a movable external shield member1970disposed at the connecting end between the collapsible chamber1920and the connecting channel1910. When placing the oral interface1900in a user's oral cavity, the internal shield member1960is placed between the teeth and lips of the user. The movable external shield member1970has a through hole in the center and can slip on the outside shell of the collapsible chamber1920and can interlock with the first griping and the second gripping structures1950,1950′. The movable external shield member1970can lean against the outside surface of the mouth and clamp the user's lips in with the internal shield member1960.FIG. 19Bshows that the movable external shield member1970can move forward and backward on the outer shell of the collapsible chamber1920, in order to interlock with different protrusions1950,1950′ of the first gripping structure and the second gripping structure and adjust tightness of clamping the user's lips.

FIG. 20AtoFIG. 20Dshow the first to fourth variations of the eighth embodiment of the present invention, respectively. The difference of these variations with the oral interface1900according to the eighth embodiment is the structure of the movable external shield members, the other parts of the variations are the same as the equivalent parts of the oral interface1900. The first variation has a movable external shield member1971which is a cross-shaped patch assembled with the collapsible chamber1920. In a use scenario of the oral interface1900, the movable external shield member1971can slip and move forward and backward on the outer shell of the collapsible chamber1920, in order to interlock with different protrusions1950and adjust tightness of clamping the user's lips. The second to fourth variations have movable external shield members1972,1973, and1974with other different shaped patch assembled with the collapsible chamber1920. In a use scenario of the oral interface1900, the movable external shield members1972,1973, and1974can slip and move forward and backward on the outer shell of the collapsible chamber1920, in order to interlock with different protrusions1950and adjust tightness of clamping the user's lips.

FIG. 21shows an oral interface device and method according to the ninth embodiment of the present invention.FIG. 21A to 21Cshow the partial cross-sectional, cross-sectional, and front views, respectively. According to the ninth embodiment of the present invention, the oral interface2100comprises a connecting tube2110with one end in fluid communication with the negative pressure source (not shown), a collapsible chamber2120with one end in fluid communication with the other end of the connecting tube2110in relative to the negative pressure source, an open end2140on the other end of the collapsible chamber2110, a non-collapsible structure2130comprising, for example, a rib disposed on at least one internal wall of the collapsible chamber2120, an internal shield member2160formed at the open end2140of the collapsible chamber2120, and an external shield member composed of reclosable fasteners (such as dual lock tape)2180,2180′ and an oral mask2170. The oral mask2170has two openings and contains absorbent2190internally. One openings of the oral mask is in fluid communication with the other end of the connecting tube2110in relative to the collapsible chamber2120, and the other opening of the oral mask2170is in fluid communication with a negative pressure source2111. The internal space of the oral mask2170allows fluid to pass through and the absorbent2190can contain absorb liquid from the connecting tube2110. The oral mask2170can have a pair of ear loops2171. In a use scenario of the oral interface2100, the oral interface2100is placed in the anterior portion of the oral cavity of a user. The internal shield member2160is placed between the teeth and the lips. The reclosable fasteners (such as dual lock tape)2180,2180′ have one side attached to regions above and below the lips. The mask2170has one side with dual lock's surface characteristics and can be attached to another side of the reclosable fasteners (such as dual lock tape)2180,2180. The pair of the ear loops2172of the oral mask2171can be hooked on the user's ears to facilitate fixing the oral mask2170. When applying negative pressure to generate a negative pressure environment in a user's cavity, liquid secreted from the user's oral cavity flows through the connecting tube2110and then is absorbed by the absorbent2190of the oral mask2170without entering the negative pressure source2112.

FIG. 22shows an oral interface device and method according to the tenth embodiment of the present invention.FIG. 22A to 22Bshow front and side views in a use scenario of the tenth embodiment.FIG. 22Cshows another use scenario. According to the tenth embodiment of the present invention, an oral interface2200comprises a connecting tube2210, a collapsible chamber2220, a non-collapsible structure (not shown), an external shield member2270, and an adhesive patch. The connecting tube2210has one end connecting to the collapsible chamber2220. The connecting tube2210extends and passes through inside of the external shield member2270and forms a curved portion outside of the external shield member2270, and passes through again and is fixed at the tube slot structure2275, and then connects the connecting tube's the other end to the negative pressure source (not shown). The curved portion of the connecting tube2210forms an ear loop2272. In a use scenario of the oral interface2200, the ear loop2272formed by the curved portion of the connecting tube2210hooks on a user's ear and the adhesive patch2280attached to the user's lips near the corner of the mouth. The connecting tube2210can slide in the tube slot structure2275to adjust size of the ear look2272, in order to fit different users' size or wear tightness. Besides, the collapsible chamber2220of the oral interface2200and the non-collapsible structure can apply above-mentioned other embodiments and their variations, thus descriptions of which will not be repeated here.FIG. 22Cshows another use scenario of the oral interface2200. The connecting tube2210extends and passes through inside of the external shield member2270, and it does not passes through the external shield member2270again and fixes on the tube slot structure2275but connects is the other end directly to the negative pressure source. The adhesive patch2280is attached to the user's lips near the corner of the mouth.

FIG. 23shows a variation of the tenth embodiment of the present invention.FIG. 23A to 23Bshow the front and side views in a use scenario of the variation.FIG. 22Cshows another use scenario. The difference between the variation and the tenth embodiment is that a T-shaped lip guard2282replaces the adhesive patch2280, and the other parts of the variation are the same as the equivalent parts of the tenth embodiment. The lip guard2282has one end connected to the external shield member2270, and the connecting tube2210extends and passes through inside of the external shield member2270and forms a curved portion outside of the external shield member2270, and passes through again and is fixed at the tube slot structure2275, and then connects the connecting tube's the other end to the negative pressure source (not shown). The curved portion of the connecting tube2210forms an ear loop2272. In a use scenario of the oral interface2200, the ear loop2272formed by the curved portion of the connecting tube2210hooks on a user's ear and the lip guard2282leans on the user's lips.FIG. 23Cshows another use scenario of the oral interface2200. The connecting tube2210extends and passes through inside of the external shield member2270, and it does not passes through the external shield member2270again and fixes on the tube slot structure2275but connects is the other end directly to the negative pressure source. The lip guard2282leans on the user's lips near the corner of the mouth.

The oral interface and methods of the present invention may further be placed at other proper location in the oral cavity, for example, between the tongue and the hard palate, between the tongue and the lower jaw (under the tongue), between the teeth and the front internal wall of the oral cavity (the upper and lower lips), between the teeth and the side walls of the oral cavity (internal walls of the cheek), or between the tongue and the soft palate. The oral interface devices and methods of the present invention may further be used in combination with other apparatus for the treatment of sleep-disordered breathing. For example, the oral interface devices of the present invention can be in combination with one-way nasal valve devices, such as those described in, for example, U.S. Pat. No. 8,061,357. By increasing airway pressure using such nasal valve devices while preventing mouth leakage in the oral cavity by using the present invention, the pressure gradient from airway to the oral cavity can be increased and maintained, thus urging the soft palate toward the oral cavity and the tongue toward the upper hard palate to clear upper airway.

The oral interface devices and methods of the present invention may further be used in combination with a conventional constant positive airway pressure (CPAP) apparatus for delivering air under positive pressure to the nasal airway. With the device of the present invention keeping mouth closing and preventing air leakage in the oral cavity, and the CPAP apparatus increasing pressure in the airway, the pressure gradient between the airway and the oral cavity can be increased and maintained, thus urging the soft palate toward the oral cavity and the tongue toward the upper hard palate to clear upper airway. Meanwhile, using the negative pressure oral interface device of the present invention, the setting pressure of the CPAP can be reduced, or furthermore the positive airway pressure treatment can periodically stop/activate or decrease/increase the positive pressure, in order to reduce the uncomfortableness of breathing caused by continuous positive pressure and increase patient compliance.

The oral interface devices and methods of the present invention may further be used in combination with other oral appliance. The oral appliance can adjust biting position of upper and lower jaws and move the lower jaw forward to increase airway space near back of the throat. With the device of the present invention to provide negative pressure, keep the mouth closed and prevent air leakage in the oral cavity, the pressure gradient between the airway and the oral cavity can be increased and maintained, thus urging the soft palate toward the oral cavity and the tongue toward the upper hard palate to clear upper airway.

The oral interface devices and methods of the present invention may further be used in combination with other breathing detection device. The breathing detection device can detect breathing flow rate, and the negative pressure delivered by the present oral interface device can be activated or increased when apnea or hypopnea events are detected. Thus the operating time of the negative pressure source can be reduced and energy-saving and quiet operation can be achieved.

The foregoing is only specific embodiments of the invention only and not intended to limit the scope of the invention patent; where others without departing from the spirit of the invention disclosed under the equivalent of completion of the change or modification, the following should be included in the patent scope.