Oropharyngeal exercise device, system and method

Abstract

Various devices and systems herein include oropharyngeal exercise devices having a pump bulb with a bulb body having a flow restriction configured in a restricted configuration in which the flow restriction is configured to restrict a flow rate of a fluid through a lumen such that a user must exert a force to increase the flow rate of the fluid. Other devices include a container and / or cover thereof to which the bulb is attached or integrated.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application 62 / 958,668, filed January 8, 2020, entitled “A Convenient Wellness Device to Exercise the Muscles in the Mouth and Throat,” the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] Various embodiments herein relate to methods and systems for treating snoring and / or sleep apnea and other conditions, and more specifically to devices and methods for strengthening muscles in the mouth and throat to reduce or eliminate snoring, sleep apnea, and / or other conditions. BACKGROUND

[0004] It is estimated that 44% of men and 28% of women in the United States habitually snore. Snoring is a sound produced during sleep by the vibration of soft tissue in the upper airway. This can negatively impact the sleep quality of a bedroom partner, leading to embarrassment or frustration for the snorer or more serious long-term effects.

[0005] Loud and habitual snoring can be an indicator of obstructive sleep apnea (OSA), which can disrupt sleep.

[0006] More than 5.9 million people in the United States are diagnosed with OSA, and it is estimated that 80% of OSA patients go undiagnosed. OSA is a serious medical condition that affects daytime sleepiness and increases the likelihood of workplace accidents, comorbidities such as heart disease and diabetes, and the chance of death.

[0007] Snoring can be caused by a number of contributing factors throughout the upper airway. The nasal passages can be congested, causing high-pitched snoring. The soft palate can relax and vibrate in the airflow. The tongue can relax, fall back, and reduce the size of the airway, causing louder snoring or breathing stops. The pharyngeal muscles of the throat can relax and collapse, causing a reduction in airway size and leading to snoring and / or breathing stops.

[0008] When a person gains weight, fat tissue can accumulate in the soft tissue of the tongue, soft palate, and throat. This can cause a reduction in airway size and cause snoring and apnea problems to worsen. As people age, the reflex response of the genioglossus muscle is significantly worsened. This tongue muscle is used to move the tongue forward during inhalation to counteract the resulting negative pressure. OSA is associated with a reduction in tone of this muscle and other muscles in the mouth and throat.

[0009] Most current solutions are based on trying to reduce tissue to increase airway size, avoiding doing anything to relax muscles, mechanically keeping the airway open, strengthening muscles, or surgically tightening or removing tissue. Each of these solutions has various drawbacks.

[0010] For example, weight loss can reduce obstructive sleep apnea, but starting or maintaining an effort to change lifestyle, diet, and exercise over a period of time can be too big a hurdle for a patient to face. Other treatments that are difficult for a patient to implement in their lifestyle include alcohol and / or tobacco cessation or sleeping on their side.

[0011] Another solution is a nasal dilator, which can be used to mechanically keep the nasal passages open throughout the night. Similarly, decongestants, saline nasal irrigation, and intranasal glucocorticoids all do a good job of keeping the nasal passages unobstructed. However, nasal passage opening only helps one of the factors that contribute to snoring, so it will only work for a subset of the population.

[0012] Continuous positive airway pressure (CPAP) is the gold standard for obstructive sleep apnea and is also prescribed for snoring. However, the compliance rate is about 40%, with 20% of patients completely rejecting the treatment. The device is uncomfortable, makes the patient feel tethered to a hose while sleeping, must be cleaned every day, is expensive, and is generally undesirable for the patient overall.

[0013] Oral appliances such as those used to advance the mandible are another form of treatment for patients. Issues that these devices face can include jaw pain and long-term side effects such as tooth movement.

[0014] Surgical approaches involve surgical procedures such as uvulopalatopharyngoplasty (UPPP), laser-assisted UPP (LAUP), radiofrequency palatoplasty, and soft palate implants. However, these surgical procedures are considered very painful, they seem to have only short-term effects, and most people would not recommend them to others.

[0015] Another solution involves strengthening the muscles in the mouth and throat through oropharyngeal exercises.

[0016] One drawback of these exercise regimens is the burden on the patient (including attending therapy sessions, practicing at home, and performing the therapy correctly by themselves). Additionally, people do not like to admit that they have a problem.

[0017] One specific method for such exercises is to play a digeridoo. However, drawbacks include having to learn how to play the instrument and the time required to learn and then play the instrument.

[0018] Another known solution is an app-based snoring exercise therapy. However, this solution has the disadvantage that it takes 15 minutes of a person's day, it cannot be used in public places as the user has to vocalize, and it can be considered repetitive for some people after 1 week of use.

[0019] There is a need in the art for improved methods, systems, and devices for treating snoring and / or sleep apnea. SUMMARY

[0020] Various exercise devices used by a user to perform various oropharyngeal exercises are discussed herein, including various bulb tube embodiments and container embodiments that operate in conjunction with the bulb tubes.

[0021] In Example 1, an oropharyngeal exercise device includes a bulb tube body including a mouthpiece sized and shaped to be inserted into a user's oral cavity, a proximal extension, and a central body disposed between the mouthpiece and the proximal extension. The device also includes a lumen defined within the bulb tube body such that the lumen is defined within the mouthpiece, the proximal extension, and the central body, a proximal opening defined in the proximal extension, wherein the proximal opening is sized to couple with an elongate tube, whereby the proximal opening allows liquid to flow into the lumen, a flow restriction structure associated with the bulb tube body, wherein the flow restriction structure includes a restricted configuration in which the flow restriction structure is configured to restrict a flow rate of a fluid through the lumen such that the user must exert at least a first amount of negative pressure to increase the flow rate of the fluid, and at least one distal opening defined in the mouthpiece and in fluid communication with the lumen, wherein the flow restriction structure can be the at least one distal opening.

[0022] Example 2 relates to the exercise device of Example 1, wherein the mouthpiece has an oval cross-sectional shape.

[0023] Example 3 relates to the exercise device of Example 1, wherein the flow restriction structure further includes a non-restricted configuration configured to allow liquid to flow through the non-restricted configuration at a rate greater than the restricted configuration, wherein the flow restriction structure is forced into the non-restricted configuration after the user has exerted at least a second amount of negative pressure, wherein the second amount is greater than the first amount.

[0024] Example 4 relates to the exercise device of Example 1, wherein the at least one distal opening is a slit defined in a distal end of a distal extension.

[0025] Example 5 relates to the exercise device of Example 4, wherein a length of the slit is substantially parallel to a cross-sectional width of the distal extension.

[0026] Example 6 relates to the exercise device of Example 4, wherein the slit includes a stress relief opening defined at each end of the slit.

[0027] Example 7 relates to the exercise device of Example 1, wherein an outer diameter of the central body is greater than an outer diameter of the distal extension and the proximal extension.

[0028] Example 8 relates to the exercise device of Example 1, wherein an outer diameter of the central body is less than an outer diameter of the distal extension and the proximal extension.

[0029] Example 9 relates to the exercise device of Example 1, wherein an outer diameter of the central body is substantially similar to an outer diameter of the distal extension and the proximal extension.

[0030] Example 10 relates to the exercise device of Example 1, wherein the flow restriction structure is disposed anywhere along a length of the lumen.

[0031] Example 11 relates to the exercise device of Example 10, wherein the flow restriction structure includes a narrow section defined within the lumen, wherein the narrow section has a diameter that is narrower than any other portion of the lumen.

[0032] In Example 12, an oropharyngeal exercise system includes a liquid container, a mask removably coupled to the liquid container, the mask including a bulb receiving opening defined therein, and a pump bulb removably positioned in the bulb receiving opening. The pump bulb includes a bulb body including a mouthpiece, a proximal extension, and a central body disposed between the mouthpiece and the proximal extension, wherein an outer diameter of the central body is greater than an outer diameter of the mouthpiece and the proximal extension. Additionally, the pump bulb includes a lumen defined within the bulb body, at least one distal opening defined in the distal extension and in fluid communication with the lumen, wherein the opening is configured to restrict liquid flow out of the lumen, and a proximal opening defined in the proximal extension, wherein the proximal opening is larger than the at least one distal opening, whereby the proximal opening allows liquid to flow into the lumen.

[0033] Example 13 relates to the exercise system of Example 12, wherein the central body includes an attachment structure, wherein the attachment structure is configured to be sealably coupled with the bulb receiving opening.

[0034] Example 14 relates to the exercise system of Example 12, further comprising an elongated tube removably positioned within the proximal opening.

[0035] Example 15 relates to the exercise system of Example 12, wherein the at least one distal opening is a slit defined in a distal end of the mouthpiece.

[0036] In Example 16, an oropharyngeal exercise device comprises a bulbous body comprising: a distal extension; a proximal extension; and a central body disposed between the distal extension and the proximal extension. The device further comprises: a lumen defined within the bulbous body such that the lumen is defined within the distal extension, the proximal extension, and the central body; and at least one distal opening defined in the distal extension and in fluid communication with the lumen. The at least one distal opening comprises a first restricted configuration configured to restrict the flow of liquid therethrough; and a second open configuration configured to allow the flow of liquid therethrough at a rate greater than the first restricted configuration, wherein the at least one distal opening is forced into the second open configuration when the user has applied a predetermined amount of compressive force to an outer wall of the distal extension by the user's tongue. Additionally, the device further comprises a proximal opening defined in the proximal extension, wherein the proximal opening is larger than the at least one distal opening, whereby the proximal opening allows the flow of liquid into the lumen.

[0037] Example 17 relates to the exercise device of Example 16, wherein the distal extension has an ovoid cross-sectional shape.

[0038] Example 18 relates to the exercise device of Example 16, wherein the distal extension is a mouthpiece configured for insertion into a user's oral cavity.

[0039] Example 19 relates to the exercise device of Example 16, wherein the at least one distal opening is defined in a distal end of the distal extension.

[0040] Example 20 relates to the exercise device of Example 16, wherein the at least one distal opening comprises a plurality of distal openings.

[0041] While a number of embodiments have been disclosed herein, other embodiments will become apparent to those skilled in the art upon reading the following detailed description and examples that follow. As will be realized, the various embodiments are capable of modifications in various obvious respects, all without departing from the spirit and scope thereof. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. Attached Figure Description

[0042] Figure 1A This is a perspective view of an exercise apparatus according to one embodiment, which includes a liquid container and a pump ball tube.

[0043] Figure 1B According to one embodiment Figure 1A An exploded perspective view of the exercise device's cover and ball tube.

[0044] Figure 1C According to one embodiment Figure 1A A perspective view of the cover and ball tube of the exercise device.

[0045] Figure 2A This is a perspective view of the pump ball tube according to another embodiment.

[0046] Figure 2B According to one embodiment Figure 2A Another perspective view of the pump ball pipe.

[0047] Figure 2C According to one embodiment Figure 2A A front view of the pump ball pipe.

[0048] Figure 2D According to one embodiment Figure 2A A side view of the pump ball pipe.

[0049] Figure 2E According to one embodiment Figure 2A A top view of the pump ball pipe.

[0050] Figure 2F According to one embodiment Figure 2A A bottom view of the pump ball pipe.

[0051] Figure 3A According to one embodiment Figure 2A A front view of the cross-section of the pump ball pipe.

[0052] Figure 3B According to one embodiment Figure 2A A side view of the cross-section of the pump ball pipe.

[0053] Figure 3C According to one embodiment Figure 2A A top view of the cross-section of the pump ball pipe.

[0054] Figure 4A This is a schematic diagram of oral exercise according to one embodiment.

[0055] Figure 4B This is a schematic diagram of another oral exercise according to one embodiment.

[0056] Figure 4C is a schematic illustration of another oral exercise according to an embodiment.

[0057] Figure 5A is a schematic illustration of a user performing a puff exercise using the exercise device according to an embodiment.

[0058] Figure 5B is a schematic illustration of a user performing a tongue press exercise using the exercise device according to an embodiment.

[0059] Figure 6 is a side view of another exercise device according to another embodiment.

[0060] Figure 7A is a schematic illustration of a user inserting the exercise device of Figure 6 into a user's mouth according to an embodiment.

[0061] Figure 7B is a schematic illustration of a user performing a puff exercise using the exercise device of Figure 6 according to an embodiment.

[0062] Figure 7C is a schematic illustration of a user performing a tongue press exercise using the exercise device of Figure 6 according to an embodiment.

[0063] Figure 8 is a perspective view of another exercise device according to another embodiment.

[0064] Figure 9A is a schematic illustration of a user inserting the exercise device of Figure 8 into a user's mouth according to an embodiment.

[0065] Figure 9B is a schematic illustration of a user performing a puff exercise using the exercise device of Figure 8 according to an embodiment.

[0066] Figure 9C is a schematic illustration of a user performing a tongue press exercise using the exercise device of Figure 8 according to an embodiment.

[0067] Figures 10A to 10D depicts side views of various pump ball tube shapes according to certain embodiments.

[0068] Figures 11A to 11I depicts top cross-sectional views of various pump ball tube cross-sectional shapes according to certain embodiments.

[0069] Figures 12A to 12D depicts side views of various mouthpiece shapes according to certain embodiments.

[0070] Figures 13A to 13F Side views of various distal opening configurations are depicted in accordance with certain embodiments.

[0071] Figure 14A , 14C Cross-sectional side views of various flow restriction sections are depicted in accordance with certain embodiments.

[0072] Figure 14B , 14D Cross-sectional top views of the flow restriction sections of 14A, 14B, 14E, 15A, 15B, and 15C are depicted in accordance with certain embodiments. Figure 14A , 14C

[0073] Figures 16A to 16H Side cross-sectional views of various connection structures for connecting a bulb to an elongate tube are depicted in accordance with certain embodiments.

[0074] Figure 17A and 17B Cross-sectional side views of additional flow restriction mechanisms are depicted in accordance with certain embodiments.

[0075] Figure 18 is a perspective view of another exercise device in accordance with another embodiment.

[0076] Figure 19A is a side view of a mouthpiece in accordance with one embodiment.

[0077] Figure 19B is a top view of the mouthpiece of Figure 19A in accordance with one embodiment.

[0078] Figure 19C is another top view of the mouthpiece of Figure 19A in accordance with one embodiment.

[0079] Figure 20 is a side view of another exercise device in accordance with another embodiment.

[0080] Figure 21A is a top view of another exercise device in accordance with another embodiment.

[0081] Figure 21B is a side view of the exercise device of Figure 20 A in accordance with one embodiment.

[0082] Figure 21C is a perspective view of the exercise device of Figure 20 A in accordance with one embodiment.

[0083] Figure 22A ​A side view of another exercise device according to another embodiment is depicted.

[0084] Figure 22B A side view of another exercise device according to another embodiment is depicted. Figure 22A A side view of another exercise device according to another embodiment is depicted.

[0085] Figure 23A A side view of another exercise device according to another embodiment is depicted.

[0086] Figure 23B A side view of another exercise device according to another embodiment is depicted. Figure 23A A side view of another exercise device according to another embodiment is depicted.

[0087] Figure 24 A side view of another exercise device according to another embodiment is depicted. DETAILED DESCRIPTION

[0088] The various device and method embodiments disclosed herein facilitate and direct oropharyngeal exercises to strengthen the muscles in the oral cavity and throat by providing a set of standardized exercise and treatment ranges that can be incorporated into a person's daily drinking / eating routine, thereby addressing the burden of learning, implementing, and improving upper airway exercises.

[0089] According to one embodiment, the device includes a liquid delivery mechanism that requires the user to perform a repetitive exercise in order to push liquid out of the mechanism so that the user can drink the liquid. The device can enable the user to use a specific motion to deliver water, thereby strengthening various muscles in the oral cavity (including, for example, the tongue, soft palate, and / or pharyngeal dilator muscles), while also providing repetition, duration of hold, and / or resistance to enhance the effect.

[0090] The various embodiments disclosed or contemplated herein serve to blend the treatment into normal daily life, so that the patient no longer needs to create a separate exercise routine, spends little time in her day to perform the treatment, and / or she does not have to mentally focus on the treatment. This makes the treatment nearly burdenless to the patient and creates a treatment that the patient does not have to think or even consciously know about.

[0091] According to certain embodiments, the device can be discrete, so that the patient can carry the device with them, can perform the treatment at any time they want, and / or does not have to worry about using the device / performing the treatment in public. This changes how the patient implements an exercise routine and gives the option of a low intensity and high frequency / duration exercise that can be performed throughout the day.

[0092] The various embodiments of the device disclosed or contemplated herein can also facilitate proper hydration, which can have beneficial effects. The device treatment mechanism according to various embodiments can be used intuitively and can guide proper exercise technique.

[0093] Figures 1A to 1C An exemplary embodiment of an oropharyngeal exercise device 10 is depicted, wherein the device 10 is a liquid container (such as a bottle or other type of container) 10 having an elongated tube (or "suction tube") 12 with a pump bulb tube (also referred to as an "oral bulb tube," "pump nozzle," and "oral nozzle") 14 disposed at a distal end as shown. In this particular implementation, the container 10 has a container body 16 and a removable cover 18 having an opening 20 defined therein such that the elongated tube 12 and bulb tube 14 can be disposed through the opening 20. As such, the tube 12 extends into the interior of the container body 16 such that the proximal end of the tube 12 is disposed at or near the bottom of the container body 16 as shown. Further, the pump bulb tube 14 extends from the cover 18 such that a user can insert the bulb tube 14 into the user's oral cavity to perform a desired exercise in order to push water from the container body 16 through the tube 12 and bulb tube 14 into the user's oral cavity. Such a liquid container device 10 having a pump bulb tube 14 can make therapy discrete, portable, and / or part of daily life.

[0094] According to certain embodiments, the removable cover 18 can have a removable protective cap 22 that can be removably disposed over the bulb tube 14 in order to protect the bulb tube 14 when the device 10 is not in use. In the particular implementation depicted, the cap 22 is rotatably attached to the cover 18 at a joint such that the cap 22 is attached to the cover 18 and can be rotatably moved between a covering position (not shown) and an open position (as shown) in which the bulb tube 14 is exposed. Alternatively, the removable cap 22 can be attached to the cover 18 via any known mechanism. Figures 1A to 1C According to certain embodiments, the removable cover 18 can have a removable protective cap 22 that can be removably disposed over the bulb tube 14 in order to protect the bulb tube 14 when the device 10 is not in use. In the particular implementation depicted, the cap 22 is rotatably attached to the cover 18 at a joint such that the cap 22 is attached to the cover 18 and can be rotatably moved between a covering position (not shown) and an open position (as shown) in which the bulb tube 14 is exposed. Alternatively, the removable cap 22 can be attached to the cover 18 via any known mechanism.

[0095] Further, the cover 18 can also have a handle 26 attached thereto that a user can use to carry the device 10 or to attach the cover 18 to another object. In this embodiment, the handle 26 is a loop 26. Alternatively, the handle 26 can take any known form for grasping onto the device 10 or attaching the device 10 to another object.

[0096] The cover 18 can be removably coupled to the container body 16 via any known attachment mechanism, including, for example, threads, a snap mechanism, etc.

[0097] In certain alternative embodiments, the cover 18 need not be a removable cover 18 as described above. Rather, the structure to which the pump bulb tube 14 is attached can be a permanent cover or cap or top on a disposable container. Alternatively, the structure can be another structure on the container, such as a side wall of the container. As such, the bulb tube 14 can be coupled to an opening on any known structure of any known type of container.

[0098] In one implementation, the pump bulb tube 14 is a pump bulb tube 14 that is configured to be inserted into a user's oral cavity and to be squeezed by the user's lips to create a vacuum in the pump bulb tube 14 and to draw water from the container body 16 through the tube 12 and into the user's oral cavity. Figures 2A to 3CThe pump bulb 14 of the device 10 is depicted in greater detail. Alternatively, it should be understood that the pump bulb 14 incorporated into the device 10 can be any bulb embodiment disclosed or contemplated herein, including but not limited to Figure 6 , 8 , the embodiments of 10A-13F, 18, and 20.

[0099] As Figures 2A to 3C depicted, the pump bulb 14 can be used not only in the device 10 depicted in the above-described and Figures 1A to 1C , but also in any other device embodiment disclosed or contemplated herein. As Figures 2A to 2D best shown in FIGS. 3A and 3B, the bulb 14 has a body 40 having a distal extension (also referred to as a “mouthpiece”) 42, a proximal extension 44, and a central body (also referred to as a “connector” or “attachment collar”) 46 disposed between the distal extension 42 and the proximal extension 44. In this embodiment, the central body 46 is an attachment collar 46 having a slot (or channel) 48 defined within the collar 46 such that the slot 48 can be used to removably attach the bulb 14 to a container device (such as the device 10 described above) or any other device into which the bulb 14 is to be incorporated or to which the bulb 14 is to be attached. Alternatively, any known attachment feature or mechanism can be used or incorporated in place of the attachment collar 46. As Figure 3A and 3B best shown, the body 40 defines an internal cavity (or “lumen”) 50 within the mouthpiece 42, the attachment collar 46, and the proximal extension 44 such that the lumen 50 extends along the length of the body 40.

[0100] In one embodiment, the mouthpiece 42 has an elliptical shape as Figure 2A , 2E and 3C best shown such that the mouthpiece 42 fits sufficiently within a user’s oral cavity. As such, as Figure 2A best shown, the width W of the mouthpiece 42 is greater than its depth D. The width W of the mouthpiece 42 is depicted in Figure 2C and 3A , while the depth of the mouthpiece 42 is depicted in Figure 2D and 3Bdepicted. In one embodiment, the width W is 9 mm and the depth D is 6 mm. Alternatively, the width W can vary from about 1 mm to about 45 mm, or in another alternative, the width W can vary from about 3 mm to about 20 mm. According to yet another alternative, the width W can vary from about 10 mm to about 17 mm. In further alternatives, the depth D can vary from about.2 mm to about 40 mm, or in another alternative, the depth D can vary from about 1 mm to about 15 mm. According to yet another alternative, the depth D can vary from about 6 mm to about 13 mm. Moreover, the dimensions of both the width W and the depth D can also be any size between these ranges. In certain embodiments, the exact width and depth dimensions of the mouthpiece can be adjusted to best fit the user's oral cavity. Alternatively, the mouthpiece 42 can have any known cross-sectional shape that facilitates positioning the mouthpiece 42 in the user's oral cavity.

[0101] As Figures 12A to 12D best shown in FIGS. 1-3, any of the mouthpieces in any of the bulb embodiments herein can have any number of configurations. For example, the mouthpiece 170 can have a cylindrical shape as shown in FIG. 4, with an opening 171 defined in the distal tip. Alternatively, the mouthpiece 172 can have a cylindrical shape with a rounded bulb at the distal tip as shown in FIG. 5. In another alternative as shown in FIG. 6, the mouthpiece 174 has a cylindrical shape with a flat end. Additionally, Figure 12A depicted in FIG. 7 has a cylindrical shape with a flat end and a rounded bulb at the distal tip. Figure 12B depicted in FIG. 8 has a cylindrical shape with a flat end and a rounded bulb at the distal tip. Figure 12C depicted in FIG. 9 has a cylindrical shape with a flat end and a rounded bulb at the distal tip. Figure 12D depicted in FIG. 10 has a cylindrical shape with a flat end and a rounded bulb at the distal tip.

[0102] In addition to the cross-sectional shape, the pump bulb 14 is also structured such that the length of the mouthpiece 42 also fits substantially in the user's oral cavity. More specifically, the diameter of the central body 46 is greater than the diameter of the mouthpiece 42 such that the proximal end of the mouthpiece 42 is distinctly defined by the protrusion of the body 46. As such, the central body 46 acts as a barrier thereby preventing the user from inserting the bulb 14 further into the user's oral cavity. In other words, the barrier of the central body 46 at the proximal end of the mouthpiece 42 defines the length of the mouthpiece 42 inserted into the user's oral cavity. Alternatively, instead of a collar or protrusion, any of the bulb embodiments herein, including the bulb 14, can have a central body that is a notch or recess such that the central body allows the user to position her lips or teeth within the notch for similar purposes of establishing the length of the mouthpiece 42 during use. In further alternatives with respect to any of the embodiments herein, the outer diameter of the central body is substantially similar to or the same as the outer diameter of at least one of the proximal extension and the mouthpiece such that there is no protrusion or notch along the length of the bulb.

[0103] According to one embodiment, the mouthpiece 42 has a length of about 35 mm from the tip 54 to the collar 46. Alternatively, the length can vary from about 7 mm to about 65 mm, or in another alternative, from about 15 mm to about 50 mm. According to yet another alternative, the length can vary from about 25 mm to about 45 mm. Further, the length dimension can also be any length between these ranges. In certain embodiments, the length of the mouthpiece can vary to best fit the user's oral cavity.

[0104] In certain embodiments, the width and length of the mouthpiece 42 are sized to provide sufficient surface area for the user to deform (such as, for example, compress) during its use, as will be described in greater detail below. Further, according to various embodiments, the volume of the internal lumen 50 is sized to limit the amount of water that will be pushed into the user's oral cavity at one time, thereby increasing the number of actions required by the user to drink a certain amount of water from the mouthpiece 42 (and thereby increasing the user's exercise).

[0105] The mouthpiece 42, as well as all other mouthpiece embodiments disclosed or contemplated herein, has at least one opening 52 defined therein that provides fluid communication between the exterior of the mouthpiece 42 and the internal lumen 50 defined therein. According to one embodiment as best shown in Figure 2A and 2E According to one embodiment as best shown in Figs. 1-3, the at least one opening 52 is a single slit 52 defined in the tip 54 of the mouthpiece 42. In certain specific embodiments, the slit 52 can have a stress relief opening 53 defined at each end of the slit 52, such that the relief openings 53 help to reduce the stress at each end of the slit 52, and thereby prevent or reduce the amount of tearing of the slit 52 at each end during use. Alternatively, any known mechanism or structure for reducing stress on the opening 52 can be incorporated into the opening 52. According to the illustrated embodiment, the slit 52 is disposed on the tip 54 such that the length of the slit 52 is horizontal with respect to the width W of the mouthpiece 42. Because the user can insert the mouthpiece 42 into her oral cavity such that the width W is horizontal with respect to the user's lips, any force exerted by the user's lips is exerted in a direction that is transverse to the length of the slit 52. As such, the force does not cause the slit 52 to open and allow liquid to easily flow through the slit. Conversely, if the length of the slit 52 were parallel to the force exerted by the user's lips or teeth, the user could bite down on or compress the mouthpiece 42 and cause the slit 52 to open and allow liquid to pass through without properly performing the targeted exercise. The benefits of the slit 52 in the operation of the mouthpiece 42 will be discussed in greater detail below.

[0106] Alternatively, at least one opening 52 in various embodiments herein can be one or more openings of any number of known shapes or configurations. That is, any number of other opening configurations, shapes, or structures can have the same characteristics and benefits as the slits 52 described above. For example, a plurality of small circular openings can also provide substantial restriction to flow until a predetermined amount of negative pressure is applied by the user, which will be described in detail below. Moreover, other opening configurations can also produce the same effect.

[0107] According to certain embodiments, the proximal extension 44 is substantially circular and has a circular opening 56 defined therein in fluid communication with the internal lumen 50 as best shown in Figure 2B and 2F According to certain embodiments, the proximal extension 44 is substantially circular and has a circular opening 56 defined therein in fluid communication with the internal lumen 50 as best shown in

[0108] As mentioned above, certain embodiments of the collar 46 have a channel 48 defined about the outer periphery of the collar 46 such that the channel 48 can be used as an attachment assembly or mechanism. More specifically, in those embodiments in which the pump bulb tube 14 is incorporated into a container, such as the container 10 discussed in detail above, the opening in the container (such as the opening 20 above) through which the bulb tube 14 is positioned can have a lip (not shown) defined about the inner surface of the opening. Thus, when the bulb tube 14 is urged into position within the opening in the container (such as the opening 20 as discussed above) to attach the bulb tube 14 thereto, the channel 48 is positioned within the opening such that the lip (not shown) is disposed within the channel 48, thereby providing a sealed coupling of the collar 46 with the cap or other assembly in which the opening (such as the opening 20) is defined. Alternatively, in those embodiments in which any of the bulb tube embodiments are not used with a container, the bulb tube need not have a channel.

[0109] As best shown in Figure 3A and 3B According to certain embodiments, the proximal extension 44 is substantially circular and has a circular opening 56 defined therein in fluid communication with the internal lumen 50 as best shown in

[0110] In one embodiment, the pump bulb 14 (and any other pump bulb disclosed or contemplated herein) is a single, unitary component made of silicone that is safe for the user. Alternatively, the bulb 14 (or any other bulb as disclosed or contemplated herein) can be made of any other known material that is pliable and can be compressed with the tongue. This can include spongy materials, woven materials, mesh materials, fabric-like materials, rubber materials, plastic materials, and / or any other known material that can be safely placed in a person's mouth and meet the required mechanical properties. In certain embodiments, the material can have a smooth and / or soft surface texture so that the material and / or the device can be comfortable for the user and / or reduce abrasion on the tongue and mouth. The material can be easily cleaned and / or dishwasher safe.

[0111] According to one embodiment, the material of the bulb 14 has a hardness of 30A on the Shore A hardness scale. Alternatively, the hardness of the material of the bulb 14 can range from about 0A on the Shore A hardness scale to about 100A on the Shore A hardness scale, or in another alternative, can range from about 15A to about 75A. According to yet another alternative, the hardness can vary from about 25A to about 45A. Further, the hardness can be any amount of hardness between these ranges. As discussed in greater detail below, the hardness of the material of the bulb 14 can be modified to vary the resistance of the bulb 14 to the user's efforts to urge liquid from the interior lumen 50 into the user's mouth, thereby adjusting the resistance to a desired level that is favorable to the user.

[0112] According to certain embodiments, the walls of the mouthpiece 42 have a thickness of about 1.5 mm along the length of the mouthpiece 42 (the sides of the mouthpiece 42) and a thickness of about 1 mm at the tip 54. Alternatively, the thickness of the sidewalls and tip of the mouthpiece 42 can vary from about.1 mm to about 10 mm, or in another alternative, can vary from about.3 mm to about 5 mm. According to yet another alternative, the thickness can vary from about.5 mm to about 2 mm. In these embodiments, the thickness of the walls of the tip 54 is less than the thickness of the sidewalls of the mouthpiece 42 in order to ensure that the resistance of the mouthpiece 42 feels uniform at the tip 54 and along the sidewalls of the mouthpiece 42.

[0113] The various characteristics of the mouthpiece 42, including the thickness of the walls of the opening 52, the hardness, the shape, and the size (such as the length of the slit 52) are factors that affect the resistance of the mouthpiece 42 and the flow of liquid through the opening 52 when the user manipulates the mouthpiece 42 during use, which will be discussed in further detail below. Accordingly, any one or more of these factors can be varied to adjust the resistance and / or the flow of liquid of the mouthpiece 42 to a level that is desired by a particular user.

[0114] The treatment provided by any of the various devices disclosed or contemplated herein can enhance the muscles of the tongue, particularly the genioglossus muscle. As discussed above, the genioglossus muscle is a muscle that is responsible for protruding the tongue and is a muscle that is often weakened in patients with sleep apnea. By enhancing the genioglossus muscle, the various devices disclosed or contemplated herein can help to reduce the severity of sleep apnea in a user. Figures 4A to 4CAs best shown in the diagram, according to certain embodiments, four main exercise movements can be performed using the device embodiments described herein, including tongue-pulling exercise 70 (e.g. Figure 4A (as shown), tongue pressing exercise 72 (as shown) Figure 4B (as shown), tongue pushing exercise 74 (as shown) Figure 4C The various apparatus embodiments described herein (shown in the document) and swallowing exercises (not shown) involve repetitive swallowing as exercises. As will be discussed in further detail herein, the various apparatus embodiments described herein can be used by a user to perform at least one or any combination of these exercises. Furthermore, as otherwise explained herein, certain apparatus embodiments enhance the user's ability to perform one or more of these exercises.

[0115] like Figure 4A The tongue-pushing exercise shown involves attempting to mimic bolus formation during normal swallowing. That is, the tongue 76 creates a bolus by extending towards the floor of the mouth. This generates negative pressure, and the edges of the tongue 76 curve upwards, creating a bowl-shaped or groove-like structure. This targets the genioglossus muscle, and without being theoretically limited, it can also target the hyoidoglossus, palatoglossus, and transverse muscles of the tongue 76. Other muscles it can target include the stylohyoidus and vertical muscles of the tongue 76.

[0116] like Figure 4B The tongue-pressing exercise shown mimics the upward pressing motion of the tongue 76 during swallowing to push a food or liquid bolus into the pharynx. The tip of the tongue 76 presses upward against the hard palate behind the front teeth, and the back of the tongue 76 presses upward in a wave-like motion, thus pushing the bolus towards the back of the throat. Without being bound by theory, it appears that the superior longitudinal muscles, along with the genioglossus, hyoidoglossus, and palatoglossus muscles, are activated together.

[0117] like Figure 4C The tongue push exercise shown is the movement of the tongue 76 in a straight line, positioned outside the mouth. This exercise activates the genioglossus muscle, and if the tongue 76 is pointed, it also activates the transverse tongue muscle. When extended, the movement can also include left, right, up, or down motions to increase the range of motion and strengthen additional and / or target-specific muscles.

[0118] In one embodiment, the exercises that can be performed by a user using any of the device embodiments disclosed herein can combine tongue suction and tongue press exercises. These exercises are natural movements used in the act of swallowing, they balance each other and activate different muscle groups, and they activate most or all of the muscles of the tongue. In addition to strengthening the muscles of the tongue and throat, this treatment method can also improve the ability to swallow. This treatment method can also promote the correct tongue rest position by exercising the tongue in a manner that brings the tongue near the correct tongue rest position, and strengthens the muscles that can bring the tongue more naturally into that position. This treatment can benefit snorers, sleep apnea patients, patients with difficulty swallowing, elderly with difficulty swallowing, people who want to tighten their muscles to look more beautiful, people who want to correct their tongue rest position, and anyone who wants to improve the strength and endurance of their tongue.

[0119] Alternatively, any combination of the three treatment exercises described above can be performed using any of the device embodiments disclosed or contemplated herein.

[0120] The method of performing the various exercises herein using any of the various device embodiments has many benefits to the user. For example, using the various device embodiments disclosed or contemplated herein links the treatment to the biologic drive of drinking water, rather than expecting the user to schedule time and exert effort to perform exercises using any of the known exercise devices available. In addition, the treatment is portable and can be performed anywhere as appropriate and convenient, it is easy to track (e.g., by counting the number of liquid bottles consumed), it promotes hydration, and it provides the desired physical improvements, including reduced snoring, reduced fatigue, improved nasal breathing, improved tongue placement, adjusted jaw line, reduced sleep problems, and improved energy. Other benefits are discussed elsewhere herein.

[0121] According to certain alternative embodiments, the various exercises herein can produce additional treatment benefits. For example, one such treatment benefit can be nasal breathing during the treatment. More specifically, nasal breathing activates the muscles of the palate and is promoted in the muscle function treatment. Additionally, according to another example, the swallowing exercises (in combination with increasing the number of swallows) activate the muscles of the soft palate.

[0122] Among the benefits of the various device embodiments herein and their methods of use, using any of the devices herein for daily drinking water results in the user no longer being forced to think about the treatment or determine when to perform the exercises. Rather, the exercises are a part of the normal daily routine of drinking water. As will be described in detail elsewhere herein, many of the various device embodiments herein can be used with a water bottle, straw, cup, cover, or any other known drinking device that can be combined with the various embodiments herein so as to be incorporated into the user’s daily routine of drinking water. In further alternatives, liquids, semi-liquids, or soft solids other than water can be used in the various devices herein.

[0123] Returning now to Figures 2A to 3C the pump bulb 14, in view of the above exercises, according to some embodiments, the combination of the mouthpiece 42 structural characteristics and the slit 52 in its tip 54 is configured to enhance the benefits of these exercises. More specifically, the wall thickness of the tip 54 (as discussed above) as well as the hardness and length of the slit 52 determine the amount of force required to open the slit 52 during use, thereby affecting the effort the user has to make to push the liquid therethrough (assuming, of course, that the mouthpiece 42 is properly positioned in the user's mouth). For example, during the tongue-pumping exercise, the slit 52 establishes a threshold of force that the user has to apply via the tongue-pumping in order to pass the liquid through the slit 52. This threshold ensures that the user has to use sufficient force via the tongue-pumping exercise in order to provide the user with the desired exercise benefits. Furthermore, due to the desired additional force / pressure being applied to the mouthpiece 42 via the tongue-pumping action and the proper execution of the tongue-pumping exercise, the combination of the slit 52 and the flexibility of the tip 54 material allows the slit 52 to expand into a larger hole, thereby allowing a greater degree of liquid flow. This expansion of the slit 52 and increased liquid flow allows the user to receive sufficient liquid to replenish the user's water needs / satisfy the user's thirst needs. The resulting flow variation (if represented in a graph) would show an S-shaped curve. Thus, the structure of the tip 54 and the slit 52 provides two configurations: (1) an initial reduced flow configuration, in which the slit 52 restricts the flow and requires the user to apply additional force, thereby encouraging the user to optimize her exercise (thereby enhancing its benefits), and (2) a subsequent enhanced flow configuration, in which the slit 52 opens due to the user applying additional force, thereby allowing sufficient flow to satisfy the user's thirst needs. That is, the structure creates an "aha" effect for the user, as she knows that she is executing the exercise properly and applying sufficient force, because she starts to flow more liquid into her mouth with less relative effort.

[0124] As discussed above, various other opening configurations can produce the same beneficial effects as the slit 52 described above. For example, a plurality of small circular openings can also provide a substantial restriction to flow until the user applies a predetermined amount of negative pressure. Furthermore, other opening configurations can also produce the same effect. Conversely, if the openings are larger and / or have less restrictive openings, instead of the slit 52 or other restrictive openings, the additional effect of increased liquid flow after a minimum threshold is cleared would not occur, and the user would not receive an indication of proper action as described above. Instead, the user can sip at a lower or higher pressure, with flow varying linearly with pressure.

[0125] In use, as Figure 5A and 5B illustrate, a pump bulb, such as the bulb 14 described above, can be used to perform, for example, the exercises described in Figure 5AThe tongue-sucking exercise shown in Figure 80 is as follows: Figure 5B The tongue pressing exercise shown is 82, or both. Additionally, supplementary exercises such as tongue pushing exercises can be performed. Figure 5A and 5B In the specific embodiments depicted herein, a pump ball tube 14 incorporated into the liquid container 10 described in detail above is used to perform the exercise. Alternatively, any apparatus embodiments disclosed herein or contemplated may be used to perform these exercises.

[0126] like Figure 5A As shown, the tongue suction exercise described above is performed using a container device 10 with a bulb tube 14. During the exercise, the tongue 86 extends toward the floor of the mouth, creating space between the tongue 86 and the hard palate 84, thereby creating negative pressure in the user's mouth, which applies suction to the bulb tube 14.

[0127] In addition, such as Figure 5B As shown, the tongue pressing exercise described above is performed using device 10 and bulb tube 14. During the exercise, the tongue 86 is pressed upward against the hard palate 84 to mimic the swallowing action of pushing food or liquid into the pharynx. More specifically, the tip of the tongue 86 is pushed to contact the hard palate 84 behind the incisors, and the back of the tongue 86 is pushed upward in a wave-like motion, such that if food / liquid is present, the tongue 86 will push the food / liquid towards the back of the throat.

[0128] Figures 6 to 7C Another exemplary embodiment of the exercise device 100 is shown. In this embodiment, the device 100 is an elongated tubular body (or “straw”) 102 with a pump ball tube (also referred to as a “perforated ball tube” or “perforated nozzle”) 104 disposed at its distal end. According to one embodiment, the ball tube 104 is attached to the distal end of the tube 102. Alternatively, the ball tube 104 is integral with the tube 102, such that the ball tube 104 and the tube 102 constitute a single component. The ball tube 104 has a nozzle section 104A distal to the tube 102 and a proximal section 104B that overlaps or connects the ball tube 104 to the tube 102. Like the ball tube 14 described above, the proximal section 104B is less flexible and does not have the same structural features as the nozzle 104A. The ball tube 104 has a cylindrical shape with a rounded tip 106. Furthermore, the X-ray tube 104 in this exemplary embodiment has a lumen 108 defined therein and a plurality of openings (or “perforations”) 110 defined in the wall of the X-ray tube 104, which provide a fluid passage between the lumen 108 and the outside of the X-ray tube 104. Alternatively, the X-ray tube 104 may have one opening, two openings, or any number of openings. In the specific embodiment shown, the opening 110 is a circular hole or a perforation 110. Alternatively, the opening 110 may have any known shape (including, for example, a slit shape).

[0129] Generally, any of the various mouthpiece embodiments disclosed or contemplated herein can have any opening configuration, shape, or number as described above. Thus, the opening can be multiple openings, three openings, two openings, a single opening, or any number of openings. For example, in Figure 13A , the mouthpiece 170 has multiple circular openings 172. Alternatively, as shown in Figure 13B , the mouthpiece 170 has a single opening 174. In another embodiment, as shown in Figure 13C , the mouthpiece 170 has multiple X-shaped openings 176. According to Figure 13D , the mouthpiece 170 has multiple larger openings 178 (larger than the openings 172 of Figure 13A . Further, according to another embodiment, as shown in Figure 13E , the mouthpiece 170 has multiple slits 180. As Figure 13F , yet another embodiment is a mouthpiece 170 having a single opening 182 defined in the distal tip of the mouthpiece 170. Alternatively, the opening can have any other geometry that allows fluid to pass through. The opening diameter, shape, and / or configuration can be designed to close during tongue-pulling exercises and open during tongue-pressing exercises. Alternatively, the opening can be open throughout tongue-pressing and tongue-pulling exercises, or in another alternative, can be open and closed throughout. According to various embodiments, the opening can be in different locations on the mouthpiece. The various configurations can also help reduce water from spraying into the back of the user’s throat and thereby causing discomfort.

[0130] In addition to what is described herein, the bulb 104 operates in the same manner as the bulb 14 embodiments discussed in detail above or any other bulb embodiments herein, such that any one or more of the three exercises discussed above can be performed using this device 100. Further, any of the additional / optional features described above with respect to other embodiments can be incorporated into this device 100 where feasible. Unlike the device 10 discussed above, this exercise device 100 is simply a tube 102 and a bulb 104, meaning that the device 100 can be inserted into and used with any liquid container.

[0131] In use, as best shown in Figures 7A to 7C , a user can place the bulb 104 in the user’s mouth (as best shown in Figure 7A ) and perform a tongue-pulling exercise (as shown in Figure 7B ) or a tongue-pressing exercise (as shown in Figure 7C ). Further, the user can also perform a tongue-push exercise as described elsewhere. The bulb 104 can be used to perform the various exercises in substantially the same manner as described above, so a more detailed description of the performance of these exercises will not be provided here.

[0132] InFigures 8 to 9C Another embodiment of an exercise device 120 is described in FIG. 12, wherein the device 120 is an elongate tube (or straw) 122, with a pump bulb 124 disposed at a distal end of the tube 122, wherein the bulb has an opening 126 defined in a distal end 128 thereof. According to one embodiment, the bulb 124 is attached to the distal end of the tube 122. Alternatively, the bulb 124 is integral with the tube 122, such that the bulb 124 and the tube 122 constitute a single assembly. The bulb 124 has a mouthpiece section 124A distal of the tube 122 and a proximal section 124B that overlaps or is coupled with the tube 122. As with the bulb 14, 104 described above, the proximal section 124B is less flexible and does not have the same structural features as the mouthpiece 124A. The bulb 124 has a generally cylindrical shape with a tapered section 130, a distal cylindrical section 132, and a proximal cylindrical section 134 that is smaller in diameter than the distal cylindrical section 132. In addition, the bulb 124 has a lumen 134 defined therein that is in fluid communication with the distal opening 126, such that the opening 126 provides a fluid passageway between the lumen 134 and the exterior of the bulb 124. The bulb 124 operates in the same manner as the bulb 14, 104 embodiments discussed in detail above or any other bulb embodiment herein, except as described herein, such that any one or more of the three exercises discussed above can be performed using this device 120. In addition, any of the additional / optional features described above with respect to the other embodiments can be incorporated into this device 120, where feasible. Like the device 100 described above, this exercise device 120 is just the tube 122 and the bulb 124, meaning that the device 120 can be inserted into and used with any liquid container.

[0133] In use, as best shown in FIG. 12, a user can place the bulb 124 in the user’s mouth (as best shown in FIG. 12A) and perform a tongue-pumping exercise (as shown in FIG. 12B) or a tongue-pressing exercise (as shown in FIG. 12C). In addition, the user can also perform a tongue-pushing exercise as described elsewhere. The bulb 124 can be used to perform the various exercises in substantially the same manner as described above, and therefore a more detailed description of the performance of these exercises will not be provided here. Figures 9A to 9C Figure 9A In use, as best shown in FIG. 12, a user can place the bulb 124 in the user’s mouth (as best shown in FIG. 12A) and perform a tongue-pumping exercise (as shown in FIG. 12B) or a tongue-pressing exercise (as shown in FIG. 12C). In addition, the user can also perform a tongue-pushing exercise as described elsewhere. The bulb 124 can be used to perform the various exercises in substantially the same manner as described above, and therefore a more detailed description of the performance of these exercises will not be provided here. Figure 9B Figure 9C As mentioned above, any of the various bulb features and / or components described herein with respect to any of the various device embodiments can be incorporated into any of the other bulb embodiments. In addition, any of the bulb embodiments herein can be incorporated into or used with any of the container embodiments disclosed or contemplated herein.

[0134] As mentioned above, any of the various bulb features and / or components described herein with respect to any of the various device embodiments can be incorporated into any of the other bulb embodiments. In addition, any of the bulb embodiments herein can be incorporated into or used with any of the container embodiments disclosed or contemplated herein.

[0135] ​​The various pump bulb embodiments herein can have any shape that fits easily into the oral cavity. Figures 10A to 10D Some non-limiting exemplary shapes of bulb embodiments are depicted. More specifically, Figure 10A A cylindrical bulb shape 140 is depicted, while Figure 10B A generally spherical bulb shape 142 is depicted. Further, Figure 10C A trapezoidal bulb shape 144 is depicted, while Figure 10D A bulb 146 is shown that is shaped to have two spherical segments. Alternatively, any bulb can have any known shape, and in further alternatives can have two or more segments of any known shape.

[0136] Various alternative embodiments can also have any known cross-sectional shape, which can be incorporated into any pump bulb embodiment. For example, various bulb embodiments can have a circular shape 150 (as shown in Figure 11A ), a rectangular shape 152 (as shown in Figure 11B ), a trapezoidal shape 154 (as shown in Figure 11C ), an oval shape 156 (as shown in Figure 11D ), a triangular shape 158 (as shown in Figure 11E ), a triangular shape with rounded corners 160 (as shown in Figure 11F ), a pentagonal shape 162 (as shown in Figure 11G ), a different pentagonal shape 164 (as shown in Figure 11H ), or a hexagonal shape 166 (as shown in Figure 11I ). Further, in any of the embodiments herein, the distal end can be rounded, flattened, inverted, open, or have any other known configuration. Further, in various alternative embodiments, the pump bulb can narrow in some areas and / or widen in other areas. Further, in certain exemplary embodiments, the pump bulb can be designed to look like a spout to make it appear discrete.

[0137] Also as discussed above, in the various bulb embodiments disclosed or contemplated herein, the bulb's hardness, thickness, volume, and / or size can have a variety of predetermined variations to allow for different levels of treatment, treatment repetitions, and / or different sizes of oral cavities of different users. By having different material thicknesses, different shapes, having filler material, being honeycombed, hollow, having a ridge structure, and / or having multiple bulb structures, any of the various bulb embodiments can distribute the force needed to compress the bulb, which is applied by the user, in different ways to provide targeted treatment.

[0138] Additionally, any of the embodiments can also have features, mechanisms, or be structurally configured to guide proper movement of the oral cavity during a tongue press exercise by compressing the bulb in a predetermined manner through the bulb-based structural features. According to certain embodiments, instructions can be provided to the user to ensure proper execution of the exercise. Alternatively, no instructions are needed.

[0139] In other embodiments with respect to any of the bulb embodiments disclosed or contemplated herein, the bulb properties can be adjusted to enhance the benefits of the tongue press exercise. That is, in certain embodiments, the elastic properties of the bulb material can cause the bulb to reform its original shape after being compressed. When the bulb returns to its initial shape, the mouthpiece opening is sealed, causing a negative pressure to be created within the bulb, thereby causing the internal lumen of the bulb to fill with liquid via the opening in the proximal extension. Once the bulb contains a desired amount of liquid, when the bulb is compressed by the user, the seal of the mouthpiece opening can be overcome, thereby causing the mouthpiece material to deform such that the internal pressure increases to the extent that the seal of the bulb opening is overcome.

[0140] Alternatively, other bulb embodiments are configured to be filled with liquid through the use of gravity, such that the bulb (and, in certain embodiments, the container attached thereto) is tilted, thereby causing the bulb to fill with liquid, such that the user can then use the mouthpiece to perform a tongue press exercise in order to drink the water. In another alternative, any of the system embodiments herein can have a container to which the bulb is attached that is configured to create a positive pressure. In various embodiments, the positive pressure can be created by, for example, reducing the volume of the container in some manner, such as by compressing the volume of the container and / or by adding air into the container.

[0141] In certain embodiments, as best shown in Figure 14A and 14B the internal lumen of any of the bulb embodiments herein, such as the exemplary bulb 200 as shown, can have at least one section or length therein defining a narrow diameter 204 to restrict airflow therethrough. The narrow diameter section (or "flow restricting section" or "neck") 204 causes a small opening or lumen 206 to be formed at any location along the length of the lumen 202 within the bulb 200. That is, the narrow section 204 can be defined within any one or more of the proximal extension, collar, and / or mouthpiece of any of the bulb embodiments herein. In one embodiment, the small opening 206 can have a diameter of about.9 mm. Alternatively, the small opening 206 can have a diameter of about.1 mm to about 2 mm. In further embodiments, as shown in Figure 14C and 14D the narrow section 204 can be two or more small openings 210 having the same effect as the single small opening 206.

[0142] In another alternative, instead of a narrow section, any of the bulb embodiments herein can have a throttle valve that requires force to open it in each flow direction - such as a check valve or non-return valve. Like the narrow section, any such valve can be provided anywhere along the length of the bulb lumen. For example, in one particular embodiment, as shown in Figure 14E and 14F , the bulb 200 can have a check valve 220 provided within the lumen 202. In additional alternatives, the check valve can be any of the valve configurations shown in Figures 15A to 15C , including Figure 15A the ball valve 222 in Figure 15B the flap valve 224 in Figure 15C and the diaphragm non-return valve 226 in Furthermore, any known valve configuration can be used in the various embodiments herein.

[0143] According to yet another alternative, the flow restriction can be an adjustable valve. For example, in one embodiment, as shown in Figure 17A , the bulb 260 has a control valve 262 with a handle 264 that can be turned or otherwise manipulated to adjust the position of a valve body 266 within a lumen 268, thereby adjusting the size of an opening within the lumen 268. Alternatively, according to another embodiment, as shown in Figure 17B , the bulb 260 has a screw valve 270 with a handle 272 that can be turned or otherwise manipulated to adjust the position of a valve body 274, thereby adjusting the size of an opening within the lumen 268.

[0144] Regardless of being configured as a narrow section or a valve, the lumen restriction can increase the pressure required to be exerted by a user during a tongue suction exercise in order to increase the flow of liquid therethrough. Furthermore, the restriction can reduce the backflow of liquid during a tongue press exercise. Alternatively, the restriction can be a restrictive aperture defined in a cap in any of the container embodiments herein. That is, instead of a restriction within the bulb, an additional opening is defined in the container cap such that air entering the container is restricted by the opening, thereby causing an increase in negative pressure when liquid is pushed out of the container (through the bulb) at a rate faster than the rate at which air is allowed to enter through the opening.

[0145] As discussed above, any of the bulbs herein can be integral with or attached to a tube and / or straw. Furthermore, any of the bulbs herein are also attached to a liquid container or cap of the container. In various embodiments, the bulb can be removable from the elongate tube to allow for easier cleaning and / or replacement with a different bulb. Various attachment methods and mechanisms can be used to attach the bulb to the elongate tube. For example, in one embodiment, as shown in Figure 16A , the bulb 230 is attached to the elongate tube 232 via a compression fit 234. Alternatively, as shown in Figure 16BAs shown, the bulb 230 is attached to the tube 232 via an internal compression fit 236. In another alternative embodiment, as shown in FIG. 2B, the bulb 230 is attached to the tube 232 via an external compression fit 238. In another alternative embodiment, as shown in FIG. 2C, the bulb 230 is attached to the tube 232 via an internal threaded connection 238. Further, as shown in FIG. 2D, the connection can be an external threaded connection 240. According to yet another alternative, as shown in FIG. 2E, the connection can be an external groove connection 242, or in another alternative, the connection can be an internal groove connection 244, as shown in FIG. 2F. In Figure 16C Figure 16D Figure 16E Figure 16F Figure 16G Another embodiment according to another embodiment is depicted in FIG. 2G, showing a latched connection 246 of the connection, while Figure 16H Another latched connection 248 is depicted in FIG. 2H. Alternatively, any known attachment method or mechanism can be used. Further, the various bulbs disclosed or contemplated herein can have lugs, plugs, markings, grooves, or some other known mechanism to control the distance the bulb is positioned on the tube. In another alternative, an O-ring can be used to help form a seal between the tube and the pump bulb.

[0146] Based on the various bulb parameters as discussed above, including wall thickness, material hardness, shape, opening size in the narrow section, mouthpiece opening size / configuration, etc., any pump bulb according to any of the various embodiments herein can be designed to be used in a low intensity, high frequency manner throughout the day. That is, the amount of force required to compress the bulb and draw the liquid can be a low intensity value to allow for normal amounts of liquid (such as, for example, water) to be consumed throughout the day, including, for example, but not limited to, 16.9 oz, 20 oz, 24 oz, 1 L, 1.5 L.

[0147] Alternatively, a pump bulb according to any of the embodiments disclosed or contemplated herein can be designed for high intensity, low frequency use. That is, a user can drink a lesser portion of water throughout the day to achieve a sufficient therapeutic level, and then use an alternative method to drink water. The user can adjust or change the exercise intensity at multiple levels. Such adjustments can include changing different pump bulbs with different compression forces by changing the wall thickness, shape, material hardness, opening size, or any other parameter discussed herein. According to certain embodiments, each bulb can be customized for a user and / or there can be bulbs with predetermined parameters for non-customized use.

[0148] ​​​​In some embodiments, any of the device embodiments described herein can be configured to provide the option of normal drinking if the user no longer wishes to exercise. For example, in one embodiment, the device allows the bulb to be removable. Furthermore, in some embodiments, any of the devices described herein can provide a location for placing or attaching a removed bulb to a bottle or cap or a separate carrying case. Alternatively, the mouthpiece and / or bulb may be retractable into and out of a space confined within a bottle or cap. In another alternative, the device may have a separate opening (separate from the bulb) on the cap or elsewhere, which is open or can be opened for drinking without using the bulb. According to another embodiment, the mouthpiece or bulb can rotate into the cap. Additionally, the pump bulb can be folded inward and enter the cap and / or the longitudinal tube.

[0149] In another implementation, instead of controlling the resistance level via the ball tube, the longitudinal tube is configured to create the desired resistance level for the user's workout. For example, as... Figure 18 As shown, device 300 has a bulb tube 302 that is removably attached to a longitudinal tube (or “straw”) 304 in a manner similar to other embodiments described elsewhere herein. In this particular embodiment, the medium within device 300 may be air, rather than a liquid. Furthermore, any other device embodiments disclosed or contemplated herein can be used with any form of fluid (liquid or gas). Alternatively, bulb tube 302 may be integral with straw 304, such that bulb tube 302 and straw 304 are a single component. Straw 304 has two inner diameters: a first decreasing inner diameter 306 and a second larger inner diameter 308. Thus, the length of straw 304 with decreasing inner diameter 306 constitutes a confined air passage 306 that provides resistance to a user attempting to push air (or alternatively, a liquid) into their mouth during use. Bulb tube 302 may be configured in a manner similar to any other bulb tube embodiment or its features described according to any embodiment disclosed or contemplated herein. In another embodiment using a gas (such as air), bulb tube 302 may not have an opening defined therein.

[0150] Alternatively, the resistance created in the longitudinal tube can be in the form of a counterforce, such as an air bladder, valve, diaphragm, impeller, or any other known mechanism or feature for providing the desired level of resistance. For example, the counterforce could be an air bladder (not shown) that inflates to create resistance. Alternatively, resistance can be created through a combination of a ball tube configuration and a longitudinal tube configuration.

[0151] exist Figures 19A to 19CIn another embodiment best illustrated, a tube 320 is provided that can provide a fluid passage via compression. More specifically, the tube 320 has a nozzle 322 having an opening 324 defined within the tube 320, which can be opened by applying a compressive force to the nozzle 322. In a particular exemplary embodiment depicted, the distal end of the nozzle 322 has a large opening 326 defined therein, and a plurality of openings 324 are disposed within the large opening 326 such that the openings 324 are positioned at a distance proximal to the distal end. More specifically, Figure 19A Line A in the middle depicts the captured in Figure 19B and 19C The suction nozzle 322 is shown in cross-section. Alternatively, an opening 324 may be located at the distal end of the suction nozzle 322. The opening 324 is configured to open or widen in diameter when a force is applied. Thus, as indicated by arrow B reflecting the applied force, the suction nozzle 322 can be compressed by the user (e.g., by the tip and / or back of the tongue) to open or widen the opening 324 to allow liquid flow. In some embodiments, multiple portions or sections along the length of the suction nozzle 322 can be compressed to open fluid paths therein. One portion may be designed to be compressed with teeth, which may allow proper nozzle positioning and / or prevent the use of the jaw in the tongue compression portion. According to some embodiments, the bulb tube 320 may have a protrusion and / or a tooth guard (“protrusion”) 328 on the suction nozzle 328 (e.g., Figure 19A (As shown), to guide proper placement in the oral cavity. Once the nozzle 322 has been compressed as needed, gravity or other mechanisms or methods allow liquid to flow into the user's oral cavity.

[0152] According to another embodiment, a system 340 can be provided that combines a bulb 342 with a container cover 344 having a valve 346 for a tongue push exercise. The cover 344 is removably attached to a container 358. Alternatively, the cover 344 can have any configuration and can be coupled to any type of container. The bulb 342 can be any bulb embodiment disclosed or contemplated herein, and can also have any of the additional or alternative features described herein. The valve 346 has a button 348, a valve body 350, a stem 352 coupling the button 348 to the valve body 350, and a tension spring 354 coupled to the button 348 such that the spring 354 pushes the button 348 and the valve body 350 to their closed positions. The valve body 350 is disposed on an underside of the cover 344 in communication with an opening 356 defined in the cover 344. When the valve 346 is in the closed position, the valve body 350 is disposed against the underside of the cover 344 such that the valve body 350 seals the closed opening 356. Conversely, when the button 348 is pushed toward the cover 344 such that the valve 346 is pushed to the open position, the valve body 350 is pushed away from the underside of the cover 344 such that the opening 356 is in fluid communication with the interior of the container 358, thereby allowing fluid to flow through the opening 356. When the force is removed from the button 348 (i.e., the user stops applying force via their tongue), the tension spring 354 pushes the button 348 back to its rest position (closed position). In this particular embodiment, the valve button 348 is disposed within a recess 360 defined in the cover 344 such that the button 348 can be pushed toward the cover 344 within the recess 360. In use, according to one embodiment, a user can use the tongue push exercise to push the button 348 "down" (toward the cover 344) such that liquid can flow through the opening 356. In addition, the user can also use the bulb 342 to perform other exercises described elsewhere herein. Alternatively, other known mechanisms (such as a twist mechanism or any other known mechanism or assembly) can be used in place of the exemplary valve 346 depicted. Regardless of the particular mechanism / assembly, the user's tongue will have to repeatedly press a button (using the tongue push exercise) to open the valve to drink the liquid.

[0153] Figures 21A to 21CAnother embodiment of a cover 370 having a tongue push valve 372 is depicted. In this exemplary embodiment, the valve 372 is positioned such that the button 374 is 'hidden' or positioned separately on the cover 370 such that a user's tongue push exercise cannot be seen by individuals in close proximity to the user during the exercise. In other words, the button 374 is positioned or the cover 370 is configured such that others cannot see what the user is doing with her tongue. In this particular embodiment, the cover 370 has a lip (or "ridge") 376 that extends outward from the outer perimeter of the cover 370 around at least a portion of the perimeter to block visual access to the top surface 367 of the cover 370 during use. Although the complete valve 372 with its valve body and other components are not shown, it should be understood that the valve 372 has the same or substantially similar components as the valve 346 described above, except as described herein. Alternatively, the valve 372 can be any known valve having any known mechanism for operation.

[0154] In another alternative tongue push valve embodiment, as best shown in Figures 22A to 24 , the valve can have a mechanism or feature for varying the force required to push with the tongue or the distance required to push the button with the tongue. For example, as best shown in Figures 22A to 22B , the cover 390 can have an adjustable lip 392 that can extend between a retracted position as shown in Figure 22A and an extended position as shown in Figure 22B , or anywhere in between. This particular mechanism can be any known mechanism that causes the lip 392 to telescope or rotate between the retracted and extended positions. As such, the adjustable positioning of the lip 392 adjusts the distance from the cover lip 392 to the button 394, which is disposed on or near the top surface 396 of the cover 390. This adjustable feature of the lip 392 allows for adjustment of the distance that a user must extend her tongue in order to successfully depress the button 394.

[0155] According to another alternative embodiment, one tongue push valve embodiment has an adjustable force component, as shown in Figure 23A and 23B . More specifically, a cover 400 is provided having a valve 402 with an adjustable tension spring 404 such that the amount of force required to push the valve 402 open can be adjusted. As shown, the tension spring 404 can be adjusted between a high tension configuration as shown in Figure 23A and a low tension configuration as shown in Figure 23B , and anywhere in between. As such, a user can adjust the spring 404, and thus the amount of force required to push the button 406 a set distance.

[0156] Figure 24Another system embodiment for a tongue push exercise is depicted, showing a container 410 with a valve 412 having a button 414, a valve body 416, and a lengthwise stem 418 coupling the button 414 to the valve body 416. In this embodiment, the valve body 416 is disposed proximate to the outer surface of a bottom wall 420 of an inner container 422 (such that the stem 418 extends through the interior of the inner container 422, as shown), such that the valve body 416 is in adjustable communication with an opening 424 in the bottom wall 420. In use, when the button 414 is pushed in by a user's tongue, the valve body 416 is pushed away from the bottom wall 420, thereby allowing liquid from an outer container 426 to enter the inner container 422 through the opening 424. When the button 414 is released, the valve body 416 returns to its position in contact with the bottom wall 420, thereby closing the opening 424. The user can then drink the liquid in the inner container 422, and repeat the process as desired.

[0157] As discussed elsewhere in this application, various different components and / or features of various embodiments disclosed or contemplated herein can be incorporated into and / or combined with any other embodiment.

[0158] While various embodiments have been described with reference to the preferred embodiments, one of ordinary skill in the art will appreciate variations from these embodiments that fall within the spirit and scope of the application.

Claims

1. An oropharyngeal exercise device, the device comprising: (a) a bulbous body, the bulbous body comprising: (i) a mouthpiece sized and shaped to be inserted into a user's oral cavity; (ii) a proximal extension; and (iii) a central body disposed between the mouthpiece and the proximal extension; (b) a lumen defined within the bulbous body such that the lumen is defined within the mouthpiece, the proximal extension, and the central body; (c) a proximal opening defined in the proximal extension, wherein the proximal opening is sized to couple with an elongate tube, whereby the proximal opening allows liquid to flow into the lumen; (d) a flow restriction structure associated with the bulbous body, wherein the flow restriction structure comprises: (i) a restricted configuration in which the flow restriction structure is configured to restrict the flow of fluid through the lumen such that the user must exert at least a first amount of negative pressure to produce a first flow rate of the fluid; and (ii) a less restricted configuration in which the flow restriction structure is configured to restrict the flow of fluid through the lumen such that the user must exert at least a second amount of negative pressure to produce a second flow rate of the fluid, wherein the second amount of negative pressure is greater than the first amount, and wherein the second flow rate is greater than the first flow rate, wherein the flow restriction structure is configured to change from the restricted configuration to the less restricted configuration in response to at least one of a tongue suction motion, a tongue press motion, a tongue push motion, or any combination thereof; and (e) at least one distal opening defined in the mouthpiece and in fluid communication with the lumen, wherein the flow restriction structure can be the at least one distal opening.

2. The exercise device of claim 1, wherein the mouthpiece has an oval cross-sectional shape.

3. The exercise device of claim 1, wherein the at least one distal opening is a slit defined in a distal end of the mouthpiece.

4. The exercise device of claim 3, wherein the length of the slit is parallel to the cross-sectional width of the mouthpiece.

5. The exercise device of claim 3, wherein the slit comprises a stress relief opening defined at each end of the slit.

6. The exercise device of claim 1, wherein the flow restriction structure is disposed anywhere along the length of the lumen.

7. The exercise device of claim 6, wherein the flow restriction structure comprises a narrow section defined within the lumen, wherein the narrow section has a narrower diameter than any other portion of the lumen.

8. The exercise device of claim 1, wherein the mouthpiece has a length of 7 mm to 65 mm.

9. The exercise device of claim 8, wherein the mouthpiece has a length of 35 mm.

10. The exercise device of claim 1, wherein the mouthpiece comprises a material having a hardness from 25A durometer to 45A durometer. ​ 11. The exercise device of claim 1, wherein the mouthpiece includes a wall having a thickness from 0.1 mm to 10 mm.

12. An oropharyngeal exercise system, the system comprising: (a) a liquid container; (b) a mask removably coupled to the liquid container, the mask including a bulb receiving opening defined in the mask; and (c) a pump bulb removably positioned in the bulb receiving opening, the pump bulb including: (i) a bulb body including: (A) a mouthpiece; (B) a proximal extension; and (C) a central body disposed between the mouthpiece and the proximal extension, wherein an outer diameter of the central body is greater than an outer diameter of the mouthpiece and the proximal extension; (ii) a lumen defined within the bulb body; (iii) at least one distal opening defined in the mouthpiece and in fluid communication with the lumen, wherein the at least one distal opening includes: (A) a restricted configuration in which a user must apply at least a first amount of negative pressure to produce a first flow rate of the fluid; and (B) a less restricted configuration in which the user must apply at least a second amount of negative pressure to produce a second flow rate of the fluid, wherein the second amount of negative pressure is greater than the first amount, wherein the at least one distal opening is configured to change from the restricted configuration to the less restricted configuration in response to at least one of a tongue suction motion, a tongue press motion, a tongue push motion, or any combination thereof; and (iv) a proximal opening defined in the proximal extension, wherein the proximal opening is larger than the at least one distal opening, whereby the proximal opening allows liquid to flow into the lumen.

13. The exercise system of claim 12, wherein the central body includes an attachment structure, wherein the attachment structure is configured to be sealably coupled with the bulb receiving opening.

14. The exercise system of claim 12, further comprising an elongate tube removably positioned within the proximal opening.

15. The exercise system of claim 12, wherein the at least one distal opening is a slit defined in a distal end of the mouthpiece.

16. The exercise system of claim 12, wherein the mouthpiece has an oval cross-sectional shape.

17. The exercise system of claim 12, wherein the mouthpiece is configured for insertion into a user’s oral cavity.

18. The exercise system of claim 12, wherein the at least one distal opening is defined in a distal end of the mouthpiece.

19. The exercise system of claim 12, wherein the at least one distal opening includes a plurality of distal openings.

Images