Abstract:
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&#39;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&#39;s oral cavity.

Description:
CROSS REFER ENCE TO RELATED APPLICATIONS 
       [0001]    This non-provisional application claims the benefit of U.S. Provisional Application No. 61/679, 457 filed on Aug. 3, 2012. The entire contents of the above application are herby incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    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. 
         [0004]    2. Description of the Prior Art 
         [0005]    Obstructive sleep apnea (OSA) is a condition in which repeated collapses in the patient&#39;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. 
         [0006]    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&#39; 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. 
         [0007]    There are several current treatment options for OSA patients. Oral interfaces are used to treat mild OSA, but they often don&#39;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&#39;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. 
         [0008]    It has been proposed to apply a negative pressure to the patient&#39;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 
       [0009]    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&#39;s airway patency during sleep. 
         [0010]    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. 
         [0011]    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 connecting to the other end of the connecting tube in relative to the negative pressure source, an open end on the collapsible chamber, a non-collapsible structure disposed on at least one internal wall 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. 
         [0012]    In another aspect, the present invention provides methods to generate negative pressure in a user&#39;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&#39;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&#39;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. 
         [0013]    Additionally, the oral interface device may be placed at one of the following places: a location between the user&#39;s tongue and hard palate, a location between the user&#39;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&#39;s tongue and soft palate. 
         [0014]    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&#39;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&#39;s lips, in order to prevent users from involuntary opening his mouth, thus maintaining oral negative pressure environment. 
         [0015]    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. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIGS. 1A and 1B  illustrate perspective and front views, respectively, of an oral interface according to a first embodiment of the present invention; 
           [0017]      FIGS. 2A to 2E  illustrate application diagrams of the oral interface according to the first embodiment of the present invention; 
           [0018]      FIGS. 3A and 3B  illustrate cross-sectional and front views, respectively, of the oral interface placed in an oral cavity without negative pressure applied according to the first embodiment of the present invention; 
           [0019]      FIGS. 3C and 3D  illustrate cross-sectional and front views, respectively, of the oral interface placed in an oral cavity with negative pressure applied according to the first embodiment of the present invention; 
           [0020]      FIG. 3E  illustrates top view of the oral interface with negative pressure applied according to the first embodiment of the present invention; 
           [0021]      FIG. 4A  illustrates a cross-sectional view without negative pressure applied and  FIGS. 4B to 4D  illustrate cross-sectional, top, and bottom view, respectively, with negative pressure applied of a variation of oral interfaces according to the first embodiment of the present invention; 
           [0022]      FIGS. 4E to 4H  illustrate top views of variations of the oral interface according to the first embodiment of the present invention;  FIGS. 5A to 5E  illustrate perspective, top-, side-, bottom-, and front-cross-sectional views, respectively, of an oral interface according to a second embodiment of the present invention; 
           [0023]      FIGS. 5F to 5K  illustrate cross-sectional and front views of variations of the oral interface according to the second embodiment of the present invention; 
           [0024]      FIG. 6A  illustrates a cross-sectional view of another variation of the oral interface according to the second embodiment of the present invention and 
           [0025]      FIG. 6B  illustrates placement of the oral interface in the user&#39;s oral cavity with negative pressure applied; 
           [0026]      FIG. 7A  illustrates a cross-sectional view of yet another variation of the oral interface according to the second embodiment of the present invention and 
           [0027]      FIG. 7B  illustrates placement of the oral interface in the user&#39;s oral cavity with negative pressure applied; 
           [0028]      FIG. 8A  illustrates a cross-sectional view of still another variation of the oral interface according to the second embodiment of the present invention and 
           [0029]      FIG. 8B  illustrates placement of the oral interface in the user&#39;s oral cavity with negative pressure applied; 
           [0030]      FIGS. 9A to 9I  illustrate application diagrams and a method of applying the oral interface according to the second embodiment of the present invention and 
           [0031]      FIG. 9J  illustrates a cross-sectional view of the oral interface in the user&#39;s oral cavity with negative pressure applied; 
           [0032]      FIGS. 10A to 10C  illustrate perspective, side, and top views, respectively, of an oral interface according to a third embodiment of the present invention; 
           [0033]      FIGS. 11A to 11E  illustrate application diagrams and a method of applying the oral interface according to the third embodiment of the present invention; 
           [0034]      FIGS. 12A to 12C  illustrate perspective views of variations of the oral interface according to the third embodiment of the present invention; 
           [0035]      FIGS. 13A to 13C  illustrate front views of the oral interface according to the third embodiment after placement in the oral cavity; 
           [0036]      FIG. 14A  illustrates a cross-sectional view of an oral interface according to a fourth embodiment of the present invention; 
           [0037]      FIG. 14B  illustrates a cross-sectional view of an oral interface according to a fifth embodiment of the present invention; 
           [0038]      FIG. 14C  illustrates a cross-sectional view of an oral interface according to a sixth embodiment of the present invention; 
           [0039]      FIGS. 15A to 15D  illustrate perspective, top, side, and front views, respectively, of a variation of the oral interface according to the fourth embodiment of the present invention; 
           [0040]      FIG. 16  illustrate a top view of another variation of the oral interface according to the fourth embodiment of the present invention; 
           [0041]      FIGS. 17A to 17F  illustrate variations of the oral interface according to the sixth embodiment of the present invention; 
           [0042]      FIG. 18  illustrates a side view of an oral interface according to a seventh embodiment of the present invention; 
           [0043]      FIG. 19A  illustrates a side view of an oral interface according to an eighth embodiment of the present invention and 
           [0044]      FIG. 19B  illustrates placement of the oral interface in the user&#39;s oral cavity with negative pressure applied; 
           [0045]      FIGS. 20A to 20D  illustrate variations of the oral interface according to the eighth embodiment of the present invention; 
           [0046]      FIGS. 21A to 21C  illustrate partial cross-sectional view, cross-sectional view with negative pressure applied, and front view of an oral interface according to a ninth embodiment of the present invention; 
           [0047]      FIGS. 22A  and  FIG. 22B  illustrates front and side views of an oral interface in placement according to a tenth embodiment of the present invention;  FIG. 22C  illustrates another placement condition of the oral interface; 
           [0048]      FIGS. 23A  and  FIG. 23B  illustrates front and side views of a variation of the oral interface according to the tenth embodiment of the present invention;  FIG. 23C  illustrates another placement condition of the oral interface. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0049]    The object, spirit, and advantages of the preferred embodiments of the present invention will be readily understood by the accompanying detailed descriptions and drawings. 
         [0050]      FIGS. 1A and 1B  show 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 interface  100  comprises a connecting tube  110 , with one end connecting to a negative pressure source (not shown); a collapsible chamber  120 , with one end connecting to the other end of the connecting tube  110  in relative to the negative pressure source; an open end  140  on another end of the collapsible chamber  120 ; a non-collapsible structure  130 , for example, comprising a rib, disposed on at least one internal wall of the collapsible chamber  120 . Referring to  FIG. 1B , the non-collapsible structure  130  has a width W 2  smaller than an internal width W 1  of the collapsible chamber  120 . The non-collapsible structure  130  has a height H 2  smaller than an internal height H 1  of the collapsible chamber  120 . 
         [0051]      FIG. 2A  to  FIG. 2E  show different views of the oral interface  100  in use. Referring to  FIGS. 2A to 2C , the collapsible chamber  120  of the oral interface  100  is 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 interface  100  can be adjusted properly, for example, the connecting tube  110  can be moved its position to the biting positioning of the left or right canine teeth, as shown in  FIGS. 2A and 2C , or the connecting tube  110  can be moved to the front teeth. Referring to  FIG. 2B , the collapsible chamber  120  has an external width W 3  smaller than the width W 4  of the user&#39;s dental arch. Moreover, as shown in  FIG. 2B , the collapsible chamber  120  of the oral interface  100  can be placed at anterior one half portion of the tongue, or preferably, anterior one third portion of the tongue. Therefore, the collapsible chamber  120  has an external length L 1  smaller than one half of the tongue length L 2 , or preferably, smaller than one third of the tongue length L 2 . Besides, as shown in  FIG. 2D , the connecting tube  110  is moved to the biting position of the canine teeth, after the user closes the mouth, an adhesive patch  150  can be further attached to a proper position near the user&#39;s lips, for example, the corner of the mouth, to prevent the user from opening the mouth involuntarily, thus avoiding the oral interface  100  dropping out of the mouth. Besides, as shown in  FIG. 2E , the oral interface  100  can further comprise an external shield member  170 , disposed between the collapsible chamber  120  and the connecting tube  110 . During usage of the oral interface  100 , the external shield member  170  can be attached to the user&#39;s mouth, in order to facilitate positioning and to limit moving of the oral interface  100  within the oral cavity, thus avoiding the oral interface  100  being swallowed or dropping out. Furthermore, the adhesive patch  150  can be attached to the external shield member  170  and upper and lower portion of the user&#39;s mouth. 
         [0052]      FIGS. 3A and 3B  show cross-sectional and front views of the oral interface  100  placed at the positions in user&#39;s oral cavity as shown in  FIGS. 2A to 2C  without the negative pressure source activated, wherein large clear space with air resides between tongue and upper palate.  FIGS. 3C and 3D  show cross-sectional and front views of the oral interface  100  with the negative pressure source activated, wherein the air in the oral cavity is evacuated through the collapsible chamber  120  of the oral interface  100  to form a negative pressure environment. Soft tissue in the oral cavity leans upon the collapsible chamber  120 , then compresses and collapses the collapsible chamber  120 , as shown in  FIG. 3E . The collapsible chamber  120  can 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 structure  130  can support the collapsible chamber  120  and maintain internal fluid passages inside the collapsible chamber  120  in a collapsed condition in the negative pressure environment, thus keeps fluid communication between the oral cavity and the negative pressure source, as shown in  FIG. 3E . When the tissue in the oral cavity is moved by a patient or involuntarily, the compressed collapsible chamber  120  may resume its original volume. The resuming process of the collapsible chamber  120  causes 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 in  FIG. 3D . The open end  140  of the collapsible chamber  120  provides fluidic communication of the oral cavity to the negative pressure source via the internal fluid passages of the collapsible chamber  120  and the connecting tube  110 . 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. 
         [0053]      FIG. 4  shows variations of the first embodiment of the present invention.  FIG. 4A  shows a cross-sectional view of the first variation without negative pressure applied.  FIGS. 4B to 4D  illustrate cross-sectional, top, and bottom view, respectively, of the first variation with negative pressure applied. The first variation of the present invention, an oral interface  400 , has a non-collapsible structure different from the oral interface  100 . The oral interface  400  has other equivalent parts the same as oral interface  100 , for example, an open end  440 , a connecting tube  410 , and a collapsible chamber  420 , etc., thus descriptions of which will not be repeated here. The oral interface  400  has a non-collapsible structure, which comprises a plurality of first ribs  430  and a plurality of second ribs  430 ′. Each individual of the first ribs  430  can be parallel to each other and spaced apart on an internal wall of the collapsible chamber  420 . Each individual of the second ribs  430 ′ can be parallel to each other and spaced apart on another internal wall, in relative to the first ribs  430 , of the collapsible chamber  420 . Besides, the first ribs  430  and the second ribs  430 ′ can have a perpendicular or non-parallel stack configuration, as shown in  FIGS. 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 in  FIGS. 4E to 4H . The other variations of the present invention, the oral interface  401 ,  402 ,  403 , or  404 , have a non-collapsible structure different from the oral interface  400  and the same other equivalent parts, for example, open ends  441 ,  442 ,  443 , or  444 , connecting tubes  411 ,  412 ,  413 , or  414 , and a collapsible chamber  421 ,  422 ,  423 , or  424 , etc., thus descriptions of which will not be repeated here. The second variation, as shown in  FIG. 4E , has a non-collapsible structure  431  with circular protruding members on the internal wall of the collapsible chamber  421 . The third variation, as shown in  FIG. 4F , has a non-collapsible structure  432  with square protruding members on the internal wall of the collapsible chamber  422 . The fourth variation, as shown in  FIG. 4G , has a non-collapsible structure  433  with triangular protruding members on the internal wall of the collapsible chamber  423 . The fifth variation, as shown in  FIG. 4H , has a non-collapsible structure  434  with cross-shaped protruding members on the internal wall of the collapsible chamber  424 . The second to fifth variations, the oral interface  401 ,  402 ,  403 , or  404 , of the first embodiment of the present invention have symmetrical or non-symmetrical non-collapsible structure  431 ′,  432 ′,  433 ′, or  434 ′ (not shown) on another internal wall of the collapsible chambers  421 ,  422 ,  423 , or  424  in relative to the non-collapsible structure  431 ,  432 ,  433 , or  434 . The non-collapsible structures can support the collapsible chambers  421 ,  422 ,  423 , or  424  when 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&#39; singular or plural permutations: circular, polygonal, cross-shaped or irregular-shaped. 
         [0054]      FIG. 5  shows the oral interface device according to the second embodiment of the present invention.  FIGS. 5A to 5E  are 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 interface  500  of the present invention comprises a connecting tube  510  with one end connected to a negative pressure source (not shown), a collapsible chamber  520  with one end connecting to the connecting tube  510  in relative to the negative pressure, an open end  540  on another end of the collapsible chamber  520 , a non-collapsible structure  530  and  530 ′ on two opposite internal walls of the collapsible chamber  520 , a first gripping structure  550  and a second gripping structure  550 ′ disposed on the two opposite external walls of the collapsible chamber  520 . The non-collapsible structures,  530  and  530 ′, comprise a plurality of first ribs  530  and a plurality of second ribs  530 ′. Each individual of the first ribs  530  can be parallel to each other and spaced apart on an internal wall of the collapsible chamber  520 . Each individual of the second ribs  530 ′ can be parallel to each other and spaced apart on another internal wall, in relative to the first ribs  530 , of the collapsible chamber  520 . Besides, the first ribs  530  and the second ribs  530 ′ can have a perpendicular or non-parallel stack configuration. The first gripping structure  550  can comprise a plurality of concave holes on the top external wall of the collapsible chamber  520 , as shown in  FIG. 5B . The second gripping structure  550 ′ can comprise a plurality of concave holes on the bottom external wall of the collapsible chamber  520 , as shown in  FIG. 5D . When the oral interface  500  is placed in a user&#39;s mouth and creates a negative pressure environment in the oral cavity by the negative pressure source, the first gripping structure  550  and the second gripping structure  550 ′ can grip the soft tissue within the user&#39;s oral cavity to facilitate positioning of the collapsible chamber  520 . The oral interface  500  of the present invention can only have single side of the gripping structure  550  disposed on one external wall of the collapsible chamber  520 . When the oral interface  500  is placed in a user&#39;s mouth and creates a negative pressure environment in the oral cavity by the negative pressure source, the gripping structure  550  can grip the soft tissue within the user&#39;s oral cavity to facilitate positioning of the collapsible chamber  520 . The gripping structure  550  comprises plural concave holes can further be through-hole and connecting with the collapsible chamber  520 . The concave holes can distribute negative pressure from the negative pressure sources and the connecting tube  510  and increase forces of the gripping structure  550  to grip soft tissues in the oral cavity in order to positioning of the collapsible chamber  520 .  FIG. 5F  to  FIG. 5K  show different variations of the oral interface device according to the second embodiment of the present invention.  FIGS. 5F and 5G  show cross-sectional and front views, respectively, of the first variation of the oral interface device placed in a user&#39;s oral cavity.  FIGS. 5F and 5G  show cross-sectional and front views, respectively, of the second variation of the oral interface device placed in a user&#39;s oral cavity.  FIGS. 5H and 5I  show cross-sectional and front views, respectively, of the second variation of the oral interface device placed in a user&#39;s oral cavity.  FIGS. 5J and 5K  show cross-sectional and front views, respectively, of the third variation of the oral interface device placed in a user&#39;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 member  5010  and an external shield member  5012 . The internal and external shield members,  5010  and  5012 , can limit movement of the oral interface  500  and 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&#39;s lip can be held between the internal shield member  5010  and external shield member  5012  while the internal shield member  5010  is disposed between the teeth and the lip and the external member  5012  leans 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 member  5014 . 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 member  5014  is disposed between and leans against the teeth and the lip. The internal shield member  5014  can 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 member  5016 . 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 member  5016  leans against external part of the mouth. The external shield member  5016  can have a larger size that covers the mouth opening to keep mouth sealed (not shown). 
         [0055]      FIG. 6  shows the fourth variation of an oral interface device according to the second embodiment of the present invention.  FIGS. 6A and 6B  show the cross-sectional view and the use scenario which the fourth variant of an oral interface device is put into a user&#39;s oral cavity with one end connected to a negative pressure source. In the second embodiment, an oral interface  600  comprises a connecting tube  610 , with one end connecting to a negative pressure source (not shown); a collapsible chamber  620 , with one end connecting to the other end of the connecting tube  610  in relative to the negative pressure source; an open end  640  on another end of the collapsible chamber  620 ; a non-collapsible structure  630 , for example, comprised a plurality of parallel ribs spaced apart, disposed on top internal wall of the collapsible chamber  620 , and a first gripping structure  650  and a second gripping structure  650 ′ disposed on top external wall and bottom external wall of the collapsible chamber  620 . The first gripping structure  650  and the second gripping structure  650 ′ may comprise several recesses. Referring to  FIG. 6B , when the vacuum applied to user&#39;s oral cavity, the tongue, soft palate, and other soft tissues are pulled forward to maintain airway patency, and the first gripping structure  650  and the second gripping structure  650 ′ may grip the tongue, hard palate, and other soft tissues to facilitate positioning of the oral interface device  600 . 
         [0056]      FIG. 7  shows the fifth variation of an oral interface device according to the second embodiment of the present invention.  FIGS. 7A and 7B  show the cross-sectional view and the use scenario of an oral interface  700  of the fifth variation placing in a user&#39;s oral cavity connected to a negative pressure source. The oral interface  700  comprises a connecting tube  710  with one end connecting to a negative pressure source (not shown); a collapsible chamber  720  with one end connecting to the other end of the connecting tube  710  in relative to the negative pressure source; an open end  740  on another end of the collapsible chamber  720 ; a non-collapsible structure  730 , for example, comprised a plurality of parallel ribs spaced apart, disposed on top internal wall of the collapsible chamber  720 , and a first gripping structure  750  and a second gripping structure  750 ′ disposed on top external wall and bottom external wall of the collapsible chamber  720 . The first gripping structure  750  and the second gripping structure  750 ′ may comprise several protrusions. Referring to  FIG. 7B , when the vacuum applied to user&#39;s oral cavity, the tongue, soft palate, and other soft tissues are pulled forward to maintain airway patency, and the first gripping structure  750  and the second gripping structure  750 ′ may grip the tongue, hard palate, and other soft tissues to facilitate positioning of the oral interface  700 . 
         [0057]      FIG. 8  shows the sixth variation of an oral interface device according to the second embodiment of the present invention.  FIGS. 8A and 8B  show the cross-sectional view and the use scenario of an oral interface of the sixth variation placing in a user&#39;s oral cavity connected to a negative pressure source. The oral interface  800  comprises a connecting tube  810 , with one end connecting to a negative pressure source (not shown); a collapsible chamber  820 , with one end connecting to the other end of the connecting tube  810  in relative to the negative pressure source; an open end  840  on another end of the collapsible chamber  820 ; a non-collapsible structure  830 , for example, comprised of a plurality of parallel ribs spaced apart, disposed on top internal wall of the collapsible chamber  820 , and a first gripping structure  850  and a second gripping structure  850 ′ on the top external wall and bottom external wall, respectively, of the collapsible chamber  820 . The first gripping structure  850  and the second gripping structure  850 ′ are formed by recesses or sucker shaped concavities on the top external wall and bottom external wall of the collapsible chamber  820 . Referring to  FIG. 8B , when the vacuum applied to a user&#39;s oral cavity, the tongue, soft palate, and other soft tissues are pulled forward to maintain airway patency, and the first gripping structure  850  and the second gripping structure  850 ′ may grip the tongue, hard palate, and other soft tissues to facilitate positioning of the oral interface  800 . When oral tissues near the first gripping structure  850  and the second gripping structure  850 ′ moves, the volume of spaces between the tissues and gripping structure  850 ,  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 interface  800  of the present invention could only have a gripping structure  850  disposed on one-side of the external wall of the collapsible chamber  820 . 
         [0058]      FIG. 9A  to  FIG. 9J  show various steps of a method for using the oral interface  500  according 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 to  FIG. 9A , to create vacuum in a user&#39;s oral cavity by using the oral interface  500 , first place the collapsible chamber  520  of the oral interface  500  into the user&#39;s oral cavity. Referring to  FIG. 9B , adjust the position of the collapsible chamber  520  on the top of the user&#39;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 chamber  520  is preferably ⅓ L, and the collapsible chamber  520  is placed at the anterior surface of tongue within about ⅓ L length from the tip of the tongue. Referring to  FIG. 9C , rotate the connecting tube  510  to a suitable orientation by using the collapsible chamber  520  as an axle center, for example, move the connecting tube  510  to the gap between the upper canine and lower canine teeth. Referring to  FIG. 9D , let the user bite upper and lower rows of teeth gently. Referring to  FIG. 9E , tear the oral strip ( 560 ,  562 ) which comprises an adhesive patch  560  and a covering  562 . Referring to  FIG. 9F , let the user close lips tightly. Referring to  FIG. 9G , apply the adhesive patch  560  on 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 tube  510  at the corner of the mouth and not moving around randomly, or aligning the center of the adhesive patch  560  with the centerline between upper and lower lips. Referring to  FIG. 9H , attach the adhesive patch  560  tightly to regions above and below the user&#39;s lips to prevent user&#39;s mouth from opening involuntarily. 
         [0059]    Referring to  FIG. 9I , connect the oral interface  500  to a negative pressure source (may comprise a liquid storage device  590 , a negative pressure connecting tube  592 , and a negative pressure generating device  594 ) and activate the negative pressure source on to create a vacuum in the user&#39;s oral cavity. The liquid storage device  590  collects excessive secretions (such as saliva) from user&#39;s oral cavity to prevent the negative pressure generation device  594  from contaminated by the secretions.  FIG. 9J  shows a cross-sectional view of the oral interface  500  connected with the negative pressure source. Under negative pressure environment, the tissues in the oral cavity may lean on the collapsible chamber  520 , compress and collapse the collapsible chamber  520 . The methods of the present invention employ a non-collapsible structure  530  to support the collapsible chamber  520  in order to maintain fluid passages when the collapsible chamber  520  is 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 structure  550  on one of the external walls of the collapsible chamber  520 . When the collapsible chamber  520  is collapsed in the negative pressure environment, the gripping structure  550  may press up against and grip the soft tissues in the user&#39;s oral cavity to facilitate stabilizing of the soft tissue in the oral cavity. 
         [0060]      FIG. 10  shows an oral interface device according to the third embodiment of the present invention.  FIG. 10A  to  FIG. 10C  show perspective, side and top views of the third embodiment, respectively. According to the third embodiment, an oral interface  1000  comprises a connecting tube  1010  with one end  1015  connecting to a negative pressure source (not shown), a collapsible chamber  1020  with one end connecting to the other end of the connecting tube  1010  in relative to the negative pressure source, an open end  1040  on another end of the collapsible chamber  1020 , a non-collapsible structure  1030 ,  1030 ′ on the two opposite internal walls of the collapsible chamber  1020 , a first gripping structure  1050  and a second gripping structure  1050 ′ on two opposite external walls of the collapsible chamber  1020 , an internal shield member  1060  and the external shield member  1070  disposed between the collapsible chamber  1000  and connecting tube  1010 . The non-collapsible structure  1030 ,  1030 ′ is the same as the non-collapsible structure  430 ,  430 ′ in  FIG. 4 , which comprises a plurality of first ribs  1030  and a plurality of second ribs  1030 ′. Each individual of the first ribs  1030  can be parallel to each other and spaced apart on an internal wall of the collapsible chamber  1020 . Each individual of the second ribs  1030 ′ can be parallel to each other and spaced apart on another internal wall of the collapsible chamber  1020 . Besides, the first ribs  1030  and the second ribs  1030 ′ can have a perpendicular or non-parallel stack configuration. The first gripping structure  1050  may comprise a plurality of recesses on the top external wall of the collapsible chamber  1020 , and the second gripping structure  1050 ′ may comprise a plurality of recesses on the bottom external wall of the collapsible chamber  1020 . 
         [0061]      FIG. 11A  to  FIG. 11E  shows application diagrams and method of applying the oral interface  1000  of the third embodiment of the present invention.  FIG. 11A  is a front view showing the first step of the method to place the collapsible chamber  1020  of the oral interface  1000  on a half or a third anterior portion of the tongue and middle region of the upper dental arch. The connecting tube  1010  is moved to the gap at the occlusive place of the upper and lower canine teeth.  FIG. 11B  is a cross-sectional view which illustrates a present method to place the internal shield member  1060  of oral interface  1000  between the teeth and the lips and to place the external shield member  1070  outside of mouth. The internal and external shield member,  1060  and  1070 , jointly clamp tissues around a user&#39;s lips and facilitate securing the oral interface  1000 .  FIG. 11C  is a front view which presents the current method by positioning the oral interface  1000  and then connecting negative pressure source (the liquid storage device  1080 , negative pressure connecting tube  1082 , the negative pressure generating device  1084 ). The liquid storage device  1080  collects excess secretions (such as saliva) from the oral cavity and prevents the secretions contaminate the negative pressure generating device  1084 .  FIG. 11D  is a cross-sectional view which illustrates a current method using the oral interface  1000  to 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 chamber  1020 . The first gripping structure  1050  and the second gripping structure  1050 ′ may grip the soft tissues in the oral cavity of a user and facilitate stabilizing the soft tissues in the oral cavity.  FIG. 11E  is a front view which shows the current method to attach the adhesive patch  1090  on the lips corner of a user after placing the oral interface  1000  in the oral cavity of a user, in order to prevent a user from opening involuntarily. 
         [0062]      FIG. 12A  to  FIG. 12C  show perspective views of variations of the oral interface  1000  according to the third embodiment of the present invention.  FIG. 13A  to  FIG. 13C  show front views of these variations in using status.  FIG. 12A  is the first variation of the oral interface  1000 . The difference from the oral interface  1000  is that the first variation uses an adhesive patch  1091  and an external fixing part  1071  to replace the combination of internal shield member  1060  and the external shield member  1070 . The other parts of the first variation are the same as the equivalent parts of the third embodiment. The external fixing part  1071  is connected to the connecting tube  1010 . The adhesive patch  1091  can cover the extension member  1071   a  of the external fixing part  1071  and 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. 12B  shows the second variation of the oral interface  1000 . The difference between oral interface  1000  and the second variation is that the second variation uses an adhesive patch  1092  and an external fixing part  1072  to replace the combination of internal shield member  1060  and the external shield member  1070 . The other parts of the first variation are the same as the equivalent parts of the oral interface  1000 . The external fixing part  1072  is attached to the connecting tube  1010 . One edge of the adhesive patch  1092  has a circular notch  1092   a.  Preferably, the size of circular notch  1092   a  is larger or equal to the external size (like the external diameter) of the connecting tube  1010  but smaller than an external size of the external fixing part  1072 . The circular notch  1092   a  encircles around the periphery of the connecting tube  1010  between the lips and the external fixing part  1072 . The adhesive patch  1092  attaches 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 patch  1092  can restrict the connecting tube  1010  from moving, as shown in  FIG. 13B .  FIG. 12C  shows the third variation of the oral interface  1000 . The difference between the oral interface  1000  and the second variation is that the second variation uses an adhesive patch  1093  and an internal shield member  1063  to replace the combination of internal shield member  1060  and the external shield member  1070 . The other parts of the first variation are the same as the equivalent parts of the oral interface  1000 . The internal shield member  1063  situates between the teeth and the lips of a user. One edge of the adhesive patch  1093  has a circular notch  1093   a.  Preferably, the size of circular notch  1093   a  is larger or equal to the external size (like the external diameter). The circular notch  1093   a  encircles around the periphery of the connecting tube  1010 . The adhesive patch  1093  attaches 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 patch  1093  can prevent the connecting tube  1010  from moving, as shown in  FIG. 13C . 
         [0063]      FIG. 14A  show an oral interface device according to the fourth embodiment of the present invention. According to the fourth embodiment, an oral interface  1400  of the present invention comprises a connecting tube  1410  with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber  1420  with one end in fluid communication with the other end of the connecting tube  1410  in relative to the negative pressure source, an open end  1440  on the other end of the collapsible chamber  1420 , a non-collapsible structure  1430 , for example, comprising at least a rib disposed on at least one internal wall of the collapsible chamber  1420 , an internal shield member  1460  formed at the open end  1440  on the collapsible chamber  1420 . When the oral interface  1400  is placed in a user&#39;s oral cavity, the collapsible chamber  1420  is placed between upper lip and lower lip, and the external width (not shown) of the collapsible chamber  1420  is smaller than the width of the user&#39;s mouth, and is preferably smaller than one half of the width of the user&#39;s mouth. The internal shield member  1460  is situated between the user&#39;s teeth and lips.  FIG. 14B  shows an oral interface device according to the fifth embodiment of the present invention. According to the fifth embodiment, an oral interface  1401  of the present invention comprises a connecting tube  1411  with one end connecting to a negative pressure source (not shown); a collapsible chamber  1421  with one end connecting to the other end of the connecting tube  1411  in relative to the negative pressure source, an open end  1441  on another end of the collapsible chamber  1421 , a non-collapsible structure  1431 , for example, comprising of at least a rib disposed on at least one internal wall of the collapsible chamber  1421 , and an external shield member  1470  disposed between the collapsible chamber  1421  and the connecting tube  1411 . When the oral interface  1401  is applied in a user&#39;s oral cavity, the collapsible chamber  1421  is placed between the user&#39;s upper lip and lower lip, and the external shield member  1470  leans on the outside surface of the user&#39;s mouth.  FIG. 14C  shows an oral interface device according to the sixth embodiment of the present invention. According to the sixth embodiment, an oral interface  1402  of the present invention comprises a connecting tube  1412  with one end connecting to a negative pressure source (not shown); a collapsible chamber  1422  with one end connecting to the other end of the connecting tube  1412  in relative to the negative pressure source, an open end  1442  on another end of the collapsible chamber  1422 , a non-collapsible structure  1432 , for example, comprising of at least a rib disposed on at least one internal wall of the collapsible chamber  1422 , an internal shield member  1462  disposed at the open end  1442  on the collapsible chamber  1422 , and an external shield member  1472  disposed between the collapsible chamber  1422  and the connecting tube  1412 . When the oral interface  1402  is applied in a user&#39;s oral cavity, the internal shield member  1462  and the external shield member  1472  may clamp the user&#39;s upper and lower lips together, and the collapsible chamber  1422  is placed between the user&#39;s upper lip and lower lip. 
         [0064]      FIG. 15  and  FIG. 16  show the first and second variations of the oral interface  1400  according to the fourth embodiment of the present invention.  FIGS. 15A to 15D  are perspective, top, side, and front views of the first variation, respectively. In the first variation, an oral interface  1500  of the present invention comprises a connecting tube  1510  with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber  1520  with one end in fluid communication with the other end of the connecting tube  1510  in relative to the negative pressure source, an open end  1540  on the other end of the collapsible chamber  1520 , a non-collapsible structure comprising a plurality of first ribs  1530  and a plurality of second ribs  1530 ′. Each individual of the first ribs  1530  can be parallel to each other and spaced apart on an internal wall of the collapsible chamber  1520 . Each individual of the second ribs  1530 ′ can be parallel to each other and spaced apart on another internal wall of the collapsible chamber  1520 . Besides, the first ribs  1530  and the second ribs  1530 ′ can have a perpendicular stack configuration. An internal shield member  1560  is disposed between the collapsible chamber  1520  and the open end  1540 . When placing the oral interface device in a user&#39;s oral cavity, the internal shield member is situated between the teeth and the lips of the user.  FIG. 15  shows a top view of the second variation. The difference between the first variation and the second variation is that internal shield member  1561  of the oral interface  1501  has a gripping structure comprising of a single or plural recesses  1551  on one surface facing the user&#39;s teeth. When applying the oral interface device with negative pressure source to create a negative pressure environment in the user&#39;s oral cavity, the recesses  1551  can grip the teeth or surrounding soft tissues to facilitate positioning of the collapsible chamber  1521 . The recesses  1551  may also enhance distribution of negative pressure to the oral cavity. The other parts of the oral interface  1501 , such as a connecting tube  1511 , a collapsible chamber  1521  with an open end  1541 , 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. 
         [0065]      FIG. 17A  and  FIG. 17B  show the first variation of the oral interface  1402  according to the sixth embodiment of the present invention. The difference between the oral interface  1700  of the first variation and the oral interface  1402  is that the external shield member comprises reclosable fasteners (such as dual lock tape)  1780 ,  1780 ′ and a shield member  1770 . When using the oral interface  1700 , one side of the reclosable fasteners  1780  and  1780 ′ are attached to regions above and below the user&#39;s lips and the shield member  1770  is attached to the other side of the reclosable fasteners  1780 ,  1780 ′ and leans against the outside surface of the user&#39;s mouth. The other parts of the oral interface  1700 , such as a connecting tube  1710 , a collapsible chamber  1720  with an open end  1740 , a non-collapsible structure  1730  and the internal shield member, are the same as the equivalent parts of the oral interface  1402 , thus descriptions of which will not be repeated here. 
         [0066]      FIG. 17C  to  FIG. 17F  show the second to fifth variations of the sixth embodiment of the present invention, respectively. The difference of these variations with the oral interface  1402  is the structure of the external shield members, the other parts of the variations are the same as the equivalent parts of the oral interface  1402 , 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 fasteners  1780 ,  1780 ′ and a movable external shield  1771  which is cross-shaped and assembled with the collapsible chamber  1720 . In a use scenario of the oral interface  1700 , one side of the reclosable fasteners  1780 ,  1780 ′ are attached to regions above and below the user&#39;s lips and the shield member  1771  is attached to the other side of the reclosable fasteners  1780 ,  1780 ′ to facilitate closing of the user&#39;s mouth. The shield member  1771  can also temporarily detach from the reclosable fasteners  1780 ,  1780 ′ to allow the user to open mouth freely. In the third to fifth variations, the external shield members comprise reclosable fasteners  1780 ,  1780 ′ and movable external shields  1772 ,  1773 , or  1774 , respectively with different shapes. In a use scenario of the oral interface  1700 , one side of the reclosable fasteners  1780 ,  1780 ′ are attached to regions above and below the user&#39;s lips and the shield members  1772 ,  1773 , or  1774  are attached to the other side of the reclosable fasteners  1780 ,  1780 ′ to facilitate closing of the user&#39;s mouth. The shield members  1772 ,  1773 , or  1774  can also temporarily detach from the reclosable fasteners  1780 ,  1780 ′ to allow the user to open mouth freely. 
         [0067]      FIG. 18  shows a side view of an oral interface device according to the seventh embodiment. According to the seventh embodiment of the present invention, an oral interface  1800  comprises a connecting tube  1810  with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber  1820  with one end in fluid communication with the other end of the connecting tube  1810  in relative to the negative pressure source, an open end  1840  on the other end of the collapsible chamber  1820 , a non-collapsible structure  1830 , for example, comprising at least a rib disposed on at least one internal walls of the collapsible chamber  1820 , an internal shield member at the open end  1840  of the collapsible chamber  1820 , and a first gripping structure and a second gripping structure. The first and second gripping structures comprise a plurality of protrusions  1850 ,  1850 ′ at the top and bottom external walls of the collapsible chamber  1820 , respectively. When the oral interface device is placed in a user&#39;s oral cavity, the internal shield member  1860  stays in between the teeth and the lips of the user. When a negative pressure environment is created in the user&#39;s oral cavity, the first and the second gripping structures can grip the user&#39;s upper and lower lips. 
         [0068]      FIG. 19A  shows an oral interface device and method according to the eighth embodiment of the present invention. According to the eighth embodiment, an oral interface  1900  comprises a connecting tube  1910  with one end in fluid communication with a negative pressure source (not shown), a collapsible chamber  1920  with one end in fluid communication with the other end of the connecting tube  1910  in relative to the negative pressure source, an open end  1940  on the other end of the collapsible chamber  1920 , a first griping structure and a second gripping structure formed by a plurality of protrusions  1950  and  1950 ′ on top and bottom external walls of the collapsible chamber  1902 , respectively, an internal shield member  1960  disposed at the open end  1940 , a movable external shield member  1970  disposed at the connecting end between the collapsible chamber  1920  and the connecting channel  1910 . When placing the oral interface  1900  in a user&#39;s oral cavity, the internal shield member  1960  is placed between the teeth and lips of the user. The movable external shield member  1970  has a through hole in the center and can slip on the outside shell of the collapsible chamber  1920  and can interlock with the first griping and the second gripping structures  1950 ,  1950 ′. The movable external shield member  1970  can lean against the outside surface of the mouth and clamp the user&#39;s lips in with the internal shield member  1960 .  FIG. 19B  shows that the movable external shield member  1970  can move forward and backward on the outer shell of the collapsible chamber  1920 , in order to interlock with different protrusions  1950 ,  1950 ′ of the first gripping structure and the second gripping structure and adjust tightness of clamping the user&#39;s lips. 
         [0069]      FIG. 20A  to  FIG. 20D  show the first to fourth variations of the eighth embodiment of the present invention, respectively. The difference of these variations with the oral interface  1900  according 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 interface  1900 . The first variation has a movable external shield member  1971  which is a cross-shaped patch assembled with the collapsible chamber  1920 . In a use scenario of the oral interface  1900 , the movable external shield member  1971  can slip and move forward and backward on the outer shell of the collapsible chamber  1920 , in order to interlock with different protrusions  1950  and adjust tightness of clamping the user&#39;s lips. The second to fourth variations have movable external shield members  1972 ,  1973 , and  1974  with other different shaped patch assembled with the collapsible chamber  1920 . In a use scenario of the oral interface  1900 , the movable external shield members  1972 ,  1973 , and  1974  can slip and move forward and backward on the outer shell of the collapsible chamber  1920 , in order to interlock with different protrusions  1950  and adjust tightness of clamping the user&#39;s lips. 
         [0070]      FIG. 21  shows an oral interface device and method according to the ninth embodiment of the present invention.  FIG. 21A to 21C  show the partial cross-sectional, cross-sectional, and front views, respectively. According to the ninth embodiment of the present invention, the oral interface  2100  comprises a connecting tube  2110  with one end in fluid communication with the negative pressure source (not shown), a collapsible chamber  2120  with one end in fluid communication with the other end of the connecting tube  2110  in relative to the negative pressure source, an open end  2140  on the other end of the collapsible chamber  2110 , a non-collapsible structure  2130  comprising, for example, a rib disposed on at least one internal wall of the collapsible chamber  2120 , an internal shield member  2160  formed at the open end  2140  of the collapsible chamber  2120 , and an external shield member composed of reclosable fasteners (such as dual lock tape)  2180 ,  2180 ′ and an oral mask  2170 . The oral mask  2170  has two openings and contains absorbent  2190  internally. One openings of the oral mask is in fluid communication with the other end of the connecting tube  2110  in relative to the collapsible chamber  2120 , and the other opening of the oral mask  2170  is in fluid communication with a negative pressure source  2111 . The internal space of the oral mask  2170  allows fluid to pass through and the absorbent  2190  can contain absorb liquid from the connecting tube  2110 . The oral mask  2170  can have a pair of ear loops  2171 . In a use scenario of the oral interface  2100 , the oral interface  2100  is placed in the anterior portion of the oral cavity of a user. The internal shield member  2160  is 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 mask  2170  has one side with dual lock&#39;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 loops  2172  of the oral mask  2171  can be hooked on the user&#39;s ears to facilitate fixing the oral mask  2170 . When applying negative pressure to generate a negative pressure environment in a user&#39;s cavity, liquid secreted from the user&#39;s oral cavity flows through the connecting tube  2110  and then is absorbed by the absorbent  2190  of the oral mask  2170  without entering the negative pressure source  2112 . 
         [0071]      FIG. 22  shows an oral interface device and method according to the tenth embodiment of the present invention.  FIG. 22A to 22B  show front and side views in a use scenario of the tenth embodiment.  FIG. 22C  shows another use scenario. According to the tenth embodiment of the present invention, an oral interface  2200  comprises a connecting tube  2210 , a collapsible chamber  2220 , a non-collapsible structure (not shown), an external shield member  2270 , and an adhesive patch. The connecting tube  2210  has one end connecting to the collapsible chamber  2220 . The connecting tube  2210  extends and passes through inside of the external shield member  2270  and forms a curved portion outside of the external shield member  2270 , and passes through again and is fixed at the tube slot structure  2275 , and then connects the connecting tube&#39;s the other end to the negative pressure source (not shown). The curved portion of the connecting tube  2210  forms an ear loop  2272 . In a use scenario of the oral interface  2200 , the ear loop  2272  formed by the curved portion of the connecting tube  2210  hooks on a user&#39;s ear and the adhesive patch  2280  attached to the user&#39;s lips near the corner of the mouth. The connecting tube  2210  can slide in the tube slot structure  2275  to adjust size of the ear look  2272 , in order to fit different users&#39; size or wear tightness. Besides, the collapsible chamber  2220  of the oral interface  2200  and the non-collapsible structure can apply above-mentioned other embodiments and their variations, thus descriptions of which will not be repeated here.  FIG. 22C  shows another use scenario of the oral interface  2200 . The connecting tube  2210  extends and passes through inside of the external shield member  2270 , and it does not passes through the external shield member  2270  again and fixes on the tube slot structure  2275  but connects is the other end directly to the negative pressure source. The adhesive patch  2280  is attached to the user&#39;s lips near the corner of the mouth. 
         [0072]      FIG. 23  shows a variation of the tenth embodiment of the present invention.  FIG. 23A to 23B  show the front and side views in a use scenario of the variation.  FIG. 22C  shows another use scenario. The difference between the variation and the tenth embodiment is that a T-shaped lip guard  2282  replaces the adhesive patch  2280 , and the other parts of the variation are the same as the equivalent parts of the tenth embodiment. The lip guard  2282  has one end connected to the external shield member  2270 , and the connecting tube  2210  extends and passes through inside of the external shield member  2270  and forms a curved portion outside of the external shield member  2270 , and passes through again and is fixed at the tube slot structure  2275 , and then connects the connecting tube&#39;s the other end to the negative pressure source (not shown). The curved portion of the connecting tube  2210  forms an ear loop  2272 . In a use scenario of the oral interface  2200 , the ear loop  2272  formed by the curved portion of the connecting tube  2210  hooks on a user&#39;s ear and the lip guard  2282  leans on the user&#39;s lips.  FIG. 23C  shows another use scenario of the oral interface  2200 . The connecting tube  2210  extends and passes through inside of the external shield member  2270 , and it does not passes through the external shield member  2270  again and fixes on the tube slot structure  2275  but connects is the other end directly to the negative pressure source. The lip guard  2282  leans on the user&#39;s lips near the corner of the mouth. 
         [0073]    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. Ser. 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. 
         [0074]    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. 
         [0075]    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. 
         [0076]    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. 
         [0077]    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.