Abstract:
A device and method of use for depressing the cheeks of a user, to limit significant motion of the cheeks and provide for enhanced inhalation and exhalation. The device may be used to enhance respiration during a variety of activities, and is especially beneficial during the use of positive airway pressure (PAP) type medical. devices The device may include a pad adapted to engage a target area of a user&#39;s cheek and to maintain cheek tissue against a bone surface during inhalation and exhalation. The device may also include at least one support element coupled to the pad to maintain the pad at the target area during a therapy session.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. application Ser. No. 12/945,826, filed Nov. 12, 2010, which claimed the benefit of U.S. Provisional Application No, 61/260,682, filed Nov. 12, 2009, and each application being incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention generally relates to a user interface device and more particularly to a device for enhancing respiration during various user activities. 
       BACKGROUND OF THE INVENTION 
       [0003]    A positive air pressure (PAP) type respiration system can be used with a face mask type device to deliver pressurized air to the patient&#39;s airway. This pressurized air is delivered via various types of face masks, a nasal mask, a nasal and mouth hybrid type mask, or a full face mask. There are a number of nasal masks such as a “nasal pillow” mask and the like, as well as other newer designs for masks such as nasal prong or oral masks. A PAP type system typically includes an air delivery hose which is connected between a PAP air source and a mask which is typically custom-fitted to the patient&#39;s face or part of the face being used. 
         [0004]    When using a PAP type device, if the patient desires to use a nasal mask or a hybrid type mask then usually a chin strap is required to keep the mouth closed, Use of either of these two types of mask devices without a chin strap device can allow pressurized air to escape from the mouth, disrupting adequate air delivery to the lungs for effective ventilation. 
         [0005]    Motion of the cheeks inward and outward can occur during certain physical exercise, during use of a PAP type device, or during the playing of an exhalation-powered musical instrument, 
         [0006]    This cheek motion can create a variability of the inner volume of the mouth cavity and cause an air accumulator effect to occur, thus making inhalation and/or exhalation less direct and efficient. This air accumulator effect can make the automatic controls of a PAP type device less sensitive, and can result in the use of higher air delivery pressure than would otherwise occur. Unnecessarily higher air delivery pressures in a PAP type device can make the use of a PAP type device less comfortable and decrease patient compliance with the prescribed treatment. Cheeks expanded by air pressure inside the oral cavity and significant cheek motion can he judged unpleasant by PAP type device users. Therefore a need exists to limit significant cheek motion during use of a PAP type device or during certain physical activity. 
         [0007]    Obstructive Sleep Apnea (OSA) and other sleep disorders can contribute to the onset of other serious chronic health problems such as high blood pressure, obesity, heart disorders, diminished concentration, excessive tiredness during the day, failing asleep while driving, and depression and anxiety disorders. Untreated OSA and other sleep disorders may contribute to serious health disorders such as autoimmune disorders and even cancer. USA and other sleep disorders which are untreated or inadequately treated can reduce one&#39;s quality of life and even seriously damage one&#39;s health over time and may contribute to a significantly shorter life expectancy. 
         [0008]    PAP devices have been developed to be automatically adjusting to detect and limit air pressure delivery required to stop the occurrence of USA, thereby making the operation of the devices more comfortable for the patient and thereby increasing the likelihood of patient compliance. Sensors have been used to determine if USA or other sleep disorders are occurring due to inadequate pressure being supplied to the air from the PAP type device for good ventilation, and automatic controls have been invented and developed for increasing the pressure of the air delivered until such USA type and other sleep disorder events are reduced or stopped. 
         [0009]    The prior art includes Australian Patent Application No. AU2005100738, to Respironics, entitled Patient Interface Device. Disclosed therein is a patient interface device which includes a frame that is sized and configured to span at least a portion of the patient&#39;s face while remaining below the patient&#39;s eyes when the patient interface device is worn by the patient. The patient interface device includes a support member that is sized and configured to span at least a portion of a patient&#39;s face while remaining below the patient&#39;s eyes. The patient 
         [0010]    interface device purportedly provides a stable platform that supports a sealing assembly on the patient, while minimizing the amount of material worn on the patient&#39;s face and head. 
       SUMMARY OF THE INVENTION 
       [0011]    Cheek depressor (CD) devices of the present invention engage a targeted region of a patient cheeks with a focused application of external forces at the targeted regions to limit significant cheek motion during inhalation and exhalation and with substantially no external forces being applied to the user&#39;s zygomatic bone or mandible by the CD devices. The target area is located between the mandible and zygomatic bone of the user. 
         [0012]    The CD device enhances the effectiveness of PAP type medical device, enhances respiration during exercise or pursuit of individual or team sports, and enhances respiration while at rest or anytime and during any leisure activity. The CD device&#39;s specific size, shape, including shape of its inner cheek facing surface, and the three used to press it against each cheek can be customized to the individual user and the specific application. The CD device can be used in combination with PAP type devices and other applications where it is helpful to enhance respiration by preventing significant cheek motion which can occur during any exercise, including sport activities and playing of musical instruments, 
         [0013]    Typically the CD device is pressed and held in place against the cheek at the target area with sufficient force to move the cheek inward to make contact with the teeth, gums and or upper or lower jaw, e.g., maxilla surfaces, but not so much force to abrade, bruise or harm the teeth, gums or upper or lower jaw or the jaw joint. The use of the CD device can prove useful by enhancing inhalation or exhalation with any activity which can produce significant cheek motion, including the forceful playing of exhalation powered musical instruments where strength of breath and stamina are important considerations. When pressed against each cheek with adequate force necessary to limit significant cheek motion, the CD device may make respiration more efficient during physical exercise, especially strenuous physical exercise, and enhances respiration any time, including during non-exercise. 
         [0014]    A cheek depressor device embodiment of the present invention offers a means of preventing significant cheek motion during inhalation or exhalation which reduces an air accumulator effect of the mouth cavity. Embodiments of the invention can be used to enhance respiration in many diverse applications, including while recreating or while using a PAP type device. Other useful applications in medicine, leisure and industry will become clear as these devices gain more use. 
         [0015]    In one embodiment, a CD device engages a target area of the cheek in order to enhance inhalation or exhalation by preventing significant cheek motion. In order for the device to be maximally effective it should be positioned to depress the targeted area of the cheek toward the inside of the mouth to cause the cheek to make contact with the teeth and gums. The device should be large enough and have its inner cheek side configured in a curved or slope manner such that it is able to provide the necessary contact with the cheek in order to prevent significant cheek motion during inhalation or exhalation. 
         [0016]    The CD device can be used to enhance respiration, including, but not limited to, during the use of medical equipment such as positive airway pressure (PAP) type devices, or during the pursuit of sports. It can also be used to assist in the playing of exhalation powered musical instruments. The invention can be used to increase the effectiveness of the medical use of PAP type medical devices, including those which are non-automatic such as a basic CPAP device, as well as those that are automatically self adjusting such as an automatic CPAP, BiPAP, Bi-Level, V-Pap, C-Flex, A-Flex or the like which are typically used to treat Obstructive Sleep Apnea (OSA) and other sleep disorders, and which automatically adjust their air delivery pressure based on the patient&#39;s response, as indicated by sensors and processed by complex algorithms and microprocessors. 
         [0017]    One object of this invention is to increase patient comfort as a means of increasing patient compliance when used with a PAP medical device. It is well known in the art that patient compliance with a PAP type device is reduced by a patient&#39;s discomfort while using that PAP type device. Therefore establishing and maintaining maximum patient comfort during the use of the PAP type device is an important and key factor in determining patient compliance. 
         [0018]    Any significant motion of the cheeks during use of a PAP type device can be perceived by some patients as uncomfortable when it becomes noticeable and this is a common occurrence if higher air delivery pressures are used, or such higher air pressures occur as a response of any automatic, self-adjusting controls of any PAP type device. 
         [0019]    Unrestricted cheek movement during use of a PAP type device can create a hydraulic accumulator effect which can reduce the effectiveness of the pressure transmission of the PAP device resulting in delayed pressure transmission, This delay of pressure transmission to the airway can necessitate higher PAP pressure settings than would otherwise be required to maintain adequate ventilation of the lungs. The accumulator effect can therefore increase the effort of the lungs needed to produce exhalation. Therefore, use of the CD device can decrease the effort of the lungs to produce inhalation and exhalation and may allow the use of lower settings of the PAP type device, enhancing comfort and compliance with the prescribed treatment. 
         [0020]    Significant cheek motion during use of a PAP device itself is judged uncomfortable in some patients, and preventing cheek motion can contribute to patient comfort during their use of a PAP type device. Use of the CD device to depress the approximate center of the cheek can decrease the effort required to exhale by significantly preventing the accumulator effect that is associated with significant cheek motion, and can thereby increase the comfort of the patient while helping to elicit a quicker more direct response in any automatic, self-adjusting controls that the PAP type device may have, helping to keep the pressure of the air delivered by the PAP type device to a minimum level by reducing the amount of OSA or sleep disorder events. 
         [0021]    An important object of the CD device is to increase the responsiveness of the automatic self-adjusting PAP device&#39;s control systems to allow a lower air delivery pressure setting than otherwise might be possible. This can help to increase patient comfort if the pressure can he somewhat reduced while still being adequate to prevent the occurrence of OSA or other sleep disorder events. It is known in the art that the higher the air delivery pressure by the PAP device, the greater the tendency for air to leak around the mask, whether it be a nose only mask, a full face mask or a hybrid form of the two. When air leaks occur due to higher air delivery pressures being used, then the solution typically is the tightening of the straps or headgear used to hold the mask type device securely to the face. It is known that tightening of the straps can decrease patient comfort in some cases. 
         [0022]    During the use of a PAP type device, holding the air delivery pressure down to the lowest possible level while still high enough to prevent the occurrence of OSA is an important consideration for PAP and mask device designers. Air teaks through the mask device, which typically occur at the edge seals of the full face type masks, can generate annoying noise which can wake the patient or his or her sleeping partner. When using an automatic self-adjusting PAP type device, these air leaks through the edge seals of the mask will typically cause the device to automatically self-adjust to a higher air delivery pressure output to compensate for the leakage and pressure reduction. The use of the CD device can result in a barrier provided against the side seals of the full face mask and can help prevent these unwanted air leaks which can be annoying and cause an unwanted increase in the pressure output of the PAP type device. 
         [0023]    Therefore, another important object of the use of this invention is to reduce the air leakage of the side seals of a full face mask during the use of a PAP type device by arranging or positioning the invention to make contact with or to reinforce those seals, thereby helping to keep those seals snug against the front sides of the cheeks, and/or serving as a barrier to prevent those seats from being displaced outward and producing unwanted leakage of air from the mask. 
         [0024]    Another object of the CD device is to provide an inexpensive, easy to manufacture means to prevent significant cheek motion in many different activities including but not limited to recreation or during the use of a PAP type devices. 
         [0025]    Another object of the invention is to provide a relatively inexpensive, easy to manufacture, easy to wear and use device which can be made integral to a PAP type device mask, chin strap or headgear, or easily installed on a headgear or chin strap for use with a PAP type device, or which can be made to he a free standing support structure similar to a pair of ear phones but positioned at the approximate center of the cheeks for many different uses, thereby providing a useful invention in many different forms which are simple and cheap to manufacture, thereby contributing to less expensive manufacturing in order to reduce carbon emissions that would otherwise be higher. 
         [0026]    Another object of the present invention is a CD that depresses the cheek at the target area to minimize or prevent an air accumulator effect within the oral pharygeal cavity in order to enhance breathing without abrading, bruising or harming the inner cheek, gums, or teeth, especially when using a PAP type unit or engaging in activities which involve hard exhalation, thereby keeping the volume of the oral pharyngeal cavity minimal during respiration, especially during exhalation which would otherwise displace the cheeks outward and expand the oral pharygeal cavity. 
         [0027]    Other purposes will appear in the ensuing specification, drawings and claims. The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]      FIG. 1  is a side elevational view of an embodiment of a cheek depressor of the present invention. 
           [0029]      FIG. 2  illustrates a target area for positioning of the device of  FIG. 1   
           [0030]      FIG. 3  is a perspective view of the cheek depressor of  FIG. 1 . 
           [0031]      FIG. 4  is a portion of the cheek depressor of  FIG. 1 . 
           [0032]      FIG. 5  is a side elevational view of a second embodiment of a cheek depressor of the present invention. 
           [0033]      FIG. 6  is a side elevational view of a spring and pad portion of the embodiment of  FIG. 5 . 
           [0034]      FIG. 7  is a side elevational view of a third embodiment of a cheek depressor, 
           [0035]      FIG. 8  is a spring and pad portion of the embodiment of  FIG. 7 . 
           [0036]      FIG. 9  illustrates a side elevational view of a fourth embodiment of a cheek depressor of the present invention. 
           [0037]      FIG. 10  is a side elevational view of a fifth embodiment of a cheek depressor of the present invention. 
           [0038]      FIG. 11  is a spring and pad portion of the embodiment of  FIG. 10 . 
           [0039]      FIG. 12  is a side elevational view of a sixth embodiment of a cheek depressor device of the present invention. 
           [0040]      FIG. 13  is a side elevational view of a pad portion of the device of  FIG. 12 . 
           [0041]      FIG. 14  is a side elevational view of the pad portion of  FIG. 11 . 
           [0042]      FIG. 15  is a side elevational view of a pad portion suitable for use with the device of  FIG. 12 . 
           [0043]      FIG. 16  is a side elevational view of a pad portion suitable for use with the device of  FIG. 12 . 
           [0044]      FIG. 17  is a view of a seventh embodiment of a cheek depressor of the present invention. 
           [0045]      FIG. 18  is another view of the cheek depressor of  FIG. 17 . 
           [0046]      FIG. 19  is another embodiment of the cheek depressor of  FIG. 17 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0047]      FIG. 1  depicts another embodiment of the invention in a free standing, yoke supported form, identified as CD assembly  100 . CD assembly  100  is a free standing unit that is comprised of a spring yoke  100  for support and placement of a pad  102  used in a pair, one affixed to each lower end of spring yoke  104 . 
         [0048]    Referring to  FIG. 2 , the target area is defined as region  40 , namely that part of the cheek where the lower lateral pterygoid process bone intersects with a maxilla bone and a zygomatic bone (also called the zygomatic arch or cheek bone). The target zone is preferably centered between the zygomatic bone and the upper teeth. The infratemporal surface of the maxilla is contained in the target zone. The posterior superior alveolar nerves cross through the target zone. The CD devices of the present invention preferably provide a force of between about 0.5 lbs-f to 3 lbs-f to the target areas on each side of the user&#39;s head. Farces in the range of about 0.05-1.5 lbs-f are delivered to the target areas via various pads of CD devices of the present invention. These external forces applied to the target area collapse the check tissue against the teeth surfaces of the user. Substantially no external force is applied by the CD device to the zygomatic bone or mandible of the user. Minimal inwardly directed forces may be applied against the lower teeth, however, substantially no external force is applied toward moving the mandible forward or rearward. 
         [0049]    As shown in  FIG. 3 , a top pad  106  is affixed to spring yoke  104  for user comfort and positioning. Pad  106  is compressible with rebound memory such that it can provide and apply upward force to spring yoke  100 . Different thicknesses of pad  106  and different rates of compressibility can be used in order to provide different levels of pressure to the target area while CD assembly  100  is properly arranged and positioned on a user. 
         [0050]    As shown in  FIG. 4 , pad  102  has a pad surface  108  which is convex. Double sided sticky tape (not shown) can be applied to the convex pad surface  108  to help keep pad  102  in proper position while arranged and positioned on the head of a user. This tape is available as a medical grade tape and has uses in affixing medical and hair appliances. Alternatively medical grade glue can be applied to the convex surface of pad surface  108 . In another embodiment, pad  102  can be manufactured with a surface comprised of a plastic or rubber like material which remains sticky but will not erode or transfer to the user, even after washing or using. These types of materials are available from several different manufacturers and can be used in the manufacture of pads like pad  102  to help keep CD assembly  100  in proper position during use, especially during hard physical exercise with a lot of physical movement and/or jarring. 
         [0051]    Spring yoke  104  can be made in several different sizes such as small, medium, large, and extra large to accommodate different users with different sized heads, or can have telescoping adjustment means built into the lower ends of each side or anywhere on each side or at the top (not shown). Spring yoke  104  is provided with a knob  110  on each side, and the knobs  110  are for retaining a strap  112 , which is shown in  FIG. 1 . Strap  112  is somewhat elastic and may be made of a rayon type strapping which has some rubber woven into it for mild elasticity, however many other choices are available for use in constructing strap  112  which would be suitable. Strap  112  is provided with an orifice at each end which is insertable over knob  110  to provide for retention of strap  112  in proper position when CD assembly  100  is arranged and positioned properly on the user as shown in  FIG. 1 . 
         [0052]    CD assembly  100  is arranged and positioned on the head of a user as shown in  FIG. 1 , and with each of pads  102  arranged and positioned to make contact with the target area of the cheek of the user. Many different configurations for spring yoke  104  can be utilized, some of which include a spring yoke designed to fit from under the chin or to fit from behind the head. Alternatively a yoke can be integrated into a headphone unit or into almost any helmet design used in sports if such design takes into account safety needs and constructs the pair of pads  102  to be suitably collapsible or displaceable upon hard impact, especially for high contact sports. CD assembly  100  can be designed and constructed such that pad  102  can be made to be adjustable at the bottom ends of spring yoke  104 , with such adjustment for angle to spring yoke  104 , or to the target area, without departing from this novel art, Manufacturing CD assembly  100  with said adjustments can allow the user to specifically adjust each pad for the desired and best contact and pressure to be applied to the target area. 
         [0053]    CD assembly  100  can be manufactured in many different configurations to fit the personal preference of different individual users. It can have a spring yoke configured and constructed which will allow it to be placed under the chin, or around the neck in back, or even placed in front of the head, above or below the nose. It can be constructed to contain ear phones for audio, enabling the user to listen to a radio, iPod or cell phone while using the CD assembly such as the type of CD assembly  100 . In addition, a yoke can be constructed of a rigid material which holds its approximate form even when worn, and the spring action for asserting pressure against the target area can be supplied by the compressibility of the pad such as pad  102  or a spring system inside or behind it. The pad can be constructed in a larger combination form such as shown in  FIG. 15 , which will depress the approximate center of the cheek and the cheek area just below the zygomatic bone. 
         [0054]      FIG. 1  shows strap  112  arranged and positioned to hold CD assembly  100  in proper position. The use of pad  106  (shown in  FIG. 3 ) to apply pressure between the user and spring yoke  104 , along with strap  112  and the pressure applied bilaterally to each cheek target area by the pair of pads  102 , provides sufficient support to keep CD assembly  100  in position in most situations, including vigorous exercise. An additional strap (not shown) could he affixed to the pair of knobs  110  and arranged and positioned to cross the forehead of the user or even under the nose of the user in order to provide good support. 
         [0055]    Of course, if the pair of pads  102  is provided with double sided medical grade adhesive or tape, then even more stability can be provided to CD assembly  100 . If the CD assembly  100  is carefully fit with suitable pressure applied at pad  106  and suitable pressure applied at the bilateral pair of target areas of the cheeks of the user, then it is possible to construct CD assembly  100  without use of any strap(s) such as strap  112 . Pad  102  itself can be constructed of a compressible foam plastic or rubber like material with rebound memory that can be arranged to exert sufficient and desired depression of the target area if a rigid yoke structure is utilized to provide support for the pair of pads used such as pad  102 . 
         [0056]    Spring yoke  104  can be shaped to provide some upward force from the horizontal to the target area, less than that applied horizontally to the target area In this embodiment an upward angle of about 35 degrees from the horizontal was used to vector the upward force into the target area. Other angles could be used including up to a vertical force, and this capability could be manufactured into the CD depressor assembly  100  allowing easy adjustment by the user. It was determined by the inventor during experimentation that CD assembly  100  works somewhat more effectively in some individuals when there is some upward angular force applied to the target area to press snugly against the lower end of the zygomatic bone and the lower side of the lower lateral pterygoid process bone while exerting slight inward pressure against the upper portion of the maxilla bone. These pressures should be sufficient to depress the target area of the cheek suitably, and also for optimal effectiveness can have some of the force applied at an upward inward angle from the horizontal, which can provide more enhancement of breathing in some, all without abrading, bruising or harming the inner side of the cheek, the gums or the teeth. 
         [0057]    Spring yoke  104  is strong enough to assert adequate pressure to each of the bilaterally positioned pads  102  to keep the target area suitably and adequately depressed without abrading, bruising or harming the array of upper teeth, gums or inner cheek. In one embodiment, a force of approximately 1.20 lbs was applied through each pad  102 . However individual needs can vary and adjustments can be designed, manufactured and incorporated into the finished product which will allow pressure to be adjusted to an increase or to a decrease within a fairly broad range, generally within 0.5 lb to 3 lbs, but individual cases could require less or more. Pad  106  can also be supplied in different thicknesses and hardnesses, if suitable means for adjusting length are not provided to CD assembly  100 . In addition telescoping means can be provided to the top of spring yoke  104  to increase or decrease the pressure applied to each of the pair of pads  102 . 
         [0058]    CD assembly  100  is designed as a freestanding unit which can be used alone or with many mask assemblies for PAP usage. CD assembly  100  can be used alone to enhance breathing and respiration during exercise or sports, or anytime based on the personal preference of the user. It may also be helpful for some who play exhalation powered musical instruments by enhancing exhalation when it is used with the small pad shown in  FIG. 1 , which depresses the area of the cheek under the zygomatic bone. 
         [0059]    When CD assembly is properly arranged and positioned such that the pair of pads  102  are suitably depressing the target area bilaterally on the cheeks and strap  112  is properly arranged and positioned to retain CD assembly  100  in proper position, breathing and respiration can be enhanced. The suitable and effective depression of the target area of the user&#39;s cheek enhances respiration in a significant number of individuals perhaps by neurological or neuromuscular stimulation means.  FIG. 1  shows how CD assembly  100  appears when properly arranged and positioned whereby the pair of pads  102  are positioned to suitably depress the target area of the cheek. For maximum effectiveness in enhancing breathing and respiration, pressure must be applied to the target area in a sustained and focused fashion, but even minimal pressures appear to enhance breathing and respiration somewhat in a significant number of individuals. 
         [0060]    A sustained and significant pressure to the target area appears to directly enhance inhalation as well as exhalation somewhat, even without depressing the approximate center of the cheek. And in addition, it was determined that if some pressure was applied to the target area in an upward angle from the horizontal, there was an additional enhancement of breathing in some individuals. CD assembly  100 , when properly arranged and positioned, may enhance breathing and respiration during normal sleeping in some individuals, even those without Obstructive Sleep Apnea (OSA) or any diagnosable sleep disorder. 
         [0061]    Sustained pressure provided to the cheek area right below the zygomatic bone can enhance breathing and respiration in some individuals. Thus the proper arranging and positioning of CD assembly can enhance breathing and respiration, and when the CD is applied to the approximate center of the cheek it can significantly reduce or substantially eliminate an air accumulator effect which can reduce the effectiveness of one&#39;s usage of a PAP device, it should be noted that sustained pressure to the cheek area just below the zygomatic bone appears to enhance breathing and respiration perhaps by neurological and/or neuromuscular stimulation. 
         [0062]    For a significant number of individuals, sustained pressure properly applied to the target area can serve to enhance breathing and respiration as long as the sustained. pressure is applied to this area in an amount great enough to depress this area of the cheek deeply but not too great to abrade the inner cheek, or bruise the upper gums or harm the upper array of teeth. The amount of pressure needed to attain this for any given individual can vary and that must be kept in mind, and different thicknesses of pads can be made available if necessary or pads can be provided with different rebound rates. 
         [0063]    The suitable depression of the target area by applied, sustained pressure can be attained by various structures represented in the illustrations or their equivalents, or in the structures disclosed but not shown specifically. For a significant number of individuals it is the sustained and focused application of pressure to this area of convergence of the lower lateral pterygoid process bone, the maxilla. bone and the zygomatic bone which allows the user to attain the maximum enhancement of breathing whether or not a particular embodiment disclosed, or an equivalent of that, depresses the approximate center of the cheek. For example if a Cheek Depressor is to be used during the use of a PAP type device or while playing an exhalation powered musical instrument, or while engaging in heavy exercise with a lot of movement and high exertion, a significant number of individuals will benefit from using an embodiment that emphasizes and focuses pressure to depress the target area of the cheek in addition to depressing the approximate center of the cheek. And for other situations where exercise is light, or there is no exercise involved, use of the Cheek Depressor in a free standing embodiment is an appropriate choice and will enhance breathing for a significant number of individuals. If an individual is engaging in an activity which requires and produces hard exhalation such as running or heavy exertion sports or playing an exhalation powered musical instrument, then it would be a good choice to use a Cheek Depressor embodiment which depresses the approximate center of the cheek and also focuses specific pressure on the target area. 
         [0064]      FIG. 5  is a side view illustration of an embodiment of the present invention. A sports helmet assembly  10  includes a shell  12 , spring  14  and a check-engaging pad assembly  16  which is attached to spring  14 . Helmet assembly  10  includes a padded shell of traditional construction. Spring  14  at one end passes through an aperture  18  of shell  12  and is then fastened to the inside of shell  12 . A portion of spring  14  rests in a surface channel  20  in shell  12 . As described herein, pad assembly  16  defines a cheek depressing device. Spring  14  is held onto shell  12  via fasteners  22 , such as rivets, etc. 
         [0065]      FIG. 6  illustrates pad assembly  16  as including two pad portions, a hard pad portion  30  and a soft pad portion  32  which are preferably molded together and affixed to spring  14 . Soft pad portion  32  is made of a foam plastic material similar to foam rubber in its properties and is moderately compressible, whereas hard pad portion  30  is generally non-compressible. Soft pad portion  32  is thicker at its approximate center than hard pad portion  30 . During use, pad assembly  16  is positioned onto the cheek of the user and is held against the cheek by spring  14 . Hard pad portion  30  suitably depresses a target area of the cheek of the user, and soft pad portion  32  suitably depresses the approximate center of the cheek of the user with soft pad portion  32  being compressed by spring  14 . Pad assembly  16  can be custom molded, shaped, and constructed specific to each user&#39;s cheek anatomy and hard pad portion  30  and soft pad portion  32  can be constructed within pad assembly  16  in a variety of different hardnesses and compressibility to provide for individual differences. 
         [0066]    In order to put on or remove football helmet assembly  10 , the user must pull springs  14  apart to move pad assembly  16  outward away from shell  12 , after which the springs  14  can be slowly released once the helmet is donned. During hard shocks spring  14  will be able to flex somewhat thereby adjusting to the exact temporary position of the users face and head inside football helmet assembly  10 . The simultaneous depression of the target area and the approximate center of each cheek can provide enhanced breathing. 
         [0067]    A helmet assembly can be constructed with an integral cheek depressor in a variety of alternate ways. For example, a rigid plate which is shaped approximate to the size of the intended cheek depressor can be attached to the lower front edge of each side of the helmet closest to the chin of the user and this plate can be attached by use of a spring hinge which will apply the desired pressure to the specific pad design and size. A smaller plate may be used to hold a pad intended to depress the target area only, or a larger plate may be used to hold a pad. intended to depress the target area of the cheek and also the approximate center of the cheek. A combination pad assembly comprised of a hard pad and a soft more compressible pad may also be used. 
         [0068]      FIG. 7  depicts another embodiment of the present invention. A football helmet assembly  50  includes a bilateral and integral cheek depressor comprised of a spring  52  and pad  54 . Football helmet assembly  50  is comprised of a generally rigid shell  56  having a padded interior, Shell  56  is provided an aperture  18  through which spring  52  passes into and through. Shell  56  is also provided with a surface channel  58  deep enough to retain spring  52  at or beneath the outside surface of shell  56 . When it is properly installed and in proper operating position after football helmet assembly  50  is in proper wearing position. 
         [0069]      FIG. 8  shows spring  52  as being bent to allow it to be inserted through aperture  18  and to then engage against surface channel  58  after it has been secured in place, via for example a pair of rivets  60 . Spring  52  is provided with a tab  62  at one end which allows the user to grasp spring  52  and pull it and its attached pad  54  away from shell  56  in order to either put on or remove football helmet assembly  50 . 
         [0070]    Spring  52  is provided with a pad  54  which is substantially firm and is molded, such as with a medical grade silicone compound. Pad  54  has a slight convex shape to its inner surface which faces the user.  FIG. 8  shows spring  52  to have a double opposing bend  64  provided for spring  52  to fit properly into and through aperture  18 . If the user desires a slightly upward force applied to the target area, a slight twist can be added to spring  52 . A plurality of fasteners  66  are used to connect spring  52  to pad  54 . Spring  52  includes a plurality of apertures  68  through which fasteners  60  are received during installation. 
         [0071]    Football helmet assembly  50  of  FIG. 7  provides an integral cheek depressor allowing a football player to enhance his breathing while playing football, During hard shocks spring  52  will be able to flex somewhat thereby adjusting to the exact momentary positional change of the user&#39;s face and head inside football helmet assembly  50 . Some players might prefer a pad  54  that extends downward farther toward the approximate center of the cheek below the target area in addition to a pronounced depression of the target area 
         [0072]      FIG. 9  shows user another embodiment of the present invention including a cap assembly  70  including pads  72  held tightly in place against the target area of the cheek via spring frame  74  and spring leg  76 . Cap assembly  70  may be a baseball-style cap. 
         [0073]    Spring frame  74  and spring leg  76  in this embodiment are constructed of a spring material, such as stainless steel, which will hold its shape and exert generally constant pressure inwardly thereby directing forces into the target area of the user. Portions of cap assembly  70  may be constructed of fabric, such as a heavy duty cotton/polyester weave. The pair of spring legs  76  have pads  72  affixed to each end. Pads may be constructed of molded medical grade silicone. The inner surface (facing user) of pads  72  is somewhat rounded or convex. Spring leg  76  can be curved inward at its lower section in such a way that pad  72  can be arranged and positioned to provide a somewhat angular upward force against the target area of the cheek in addition to an approximately horizontal force applied inward against the target region. In some users a slight upward angle to the force applied provides somewhat better breathing than a straight horizontally applied force. Double sided medical grade tape tabs can be constructed of the proper size and applied to the cheek side surface of pads  72  to help keep pads  72  in proper position during vigorous exercise. 
         [0074]    Stainless steel alloy is a reasonable choice for compactness, durability and rebound memory and is selected for this embodiment, but many other materials could be used to construct spring frame  74  and spring leg  76  including other types of metals, plastics or composites providing higher strength, better rebound memory and light weight. Spring frame  74  is preferably constructed of a spring type material with good rebound memory, but it is also possible to construct frame  74  of a mostly rigid material and provide compressible pads with rebound memory instead. Spring legs  76  may be provided with a telescoping adjustment means. 
         [0075]    A cap can also be constructed to include larger cheek depressors targeted to the target area in order to decrease an air accumulator effect which may occur during hard respiration of some when they engage in vigorous exercise involving maximum exertion and hard respiration. For some a larger cheek pad may provide more optimal breathing than a smaller one. In order to provide for a larger pad  72  or increased three for pad  72  against the target area of the user&#39;s cheek, a stronger spring leg  76  can be used to provide more spring force inward. 
         [0076]    In order to don cap assembly  70 , a user spreads apart the spring legs  76 , places the cap in proper wearing position, and then releases the pair of spring legs  76 , allowing the pair of pads  72  to move inwardly to press snuggly and depress into the target area of each cheek. Legs  76  can be adjusted by increasing or decreasing their length by use of the telescoping feature built into each leg  76  (not shown but understood in the art) if necessary for good contact between the pad  72 , and the target area of the cheek. A double sided medical grade tape tab can be applied to the inner surface of each of the pair of pads  72 , which in addition to the tension provided by spring leg  76  will help keep pad  72  in proper position during hard or jarring exercise and will help keep the cap in place. The double sided tape tabs are disposable and can be replaced at each use of the hat or as frequently as desired by the user. 
         [0077]      FIG. 10  depicts another embodiment of the invention. A batting helmet assembly  80  is a protective helmet used by baseball players. Batting helmet assembly  80  has a shell  82  which contains an inner padding (not shown) which helps cushion and protect the head from shock when hit by a baseball. An aperture  84  is provided to ear protector cavity  86  to allow the wearer to hear. Batting helmet assembly  80  is typically constructed of a strong resilient type of molded plastic or fiberglass, but carbon fiber can be selected for molding as an even stronger, lighter option. Batting helmet assembly  80  is provided with a visor  87  and a cutaway  88 , which is a small cutaway from the bottom front of ear protector cavity  86 . Cutaway  88  provides clearance for the penetration of a pad  89  through ear protector cavity  86  to make good contact with the target area of the cheek of the user, 
         [0078]    Ear protector cavity  86  is provided with a spring  90  to which pad  89  is provided to its inward facing side toward the user&#39;s face, Pad  89  is molded of medical grade silicone which can feel sticky to the touch when cleaned with soapy water, Pad  89  is somewhat convex at its inner side which faces the cheek and has no sharp edges. Spring  90  is comprised in this instance of a high quality stainless steel which provides good strength and rebound memory while providing adequate force against pad  89  to depress the target area of the cheek of the user, 
         [0079]    As shown in  FIG. 11 , spring  90  is provided with apertures  91  at each end. These end apertures  91  are used to attach spring  90  to ear protector cavity  86  via, for example, rivets  92  passing through holes provided to shell  82  (not shown), Threaded fasteners  93  are used to secured pad  89  to spring  90 . Other types of fasteners and even glue pads or glue can also be used to affix pad  89  to spring  90 . Pad  89  can be provided in different widths in order to provide for individual differences in facial anatomy, thereby insuring proper tension to spring  90  which will in turn provide proper depression of the target area of the cheek. Tab  94  is provided at one end of spring  90  to provide a point for the user to grab and manipulate pad  89  away from the target area of the cheek, so that the helmet can be put on or removed. 
         [0080]    As shown in  FIG. 10 , batting helmet assembly  80  positions pad  89  against the target area of the cheek via. spring  90 . The integral use of a cheek depressor to a batting helmet assembly  80  allows enhanced breathing for the batter. Batting helmet assembly  80  can be donned or removed by grasping tabs  94  and pulling each spring  90  outward to thereby pull each pad  89  away from the cheek of the user. 
         [0081]      FIG. 12  depicts another embodiment of a CD assembly having pad  200  providing compression of cheek. tissue under the cheek bone (zygomatic bone) and above the jaw bone. Pad  200  is compressed against the cheek but without abrading, bruising or harming the teeth gums or cheek. A PAP mask assembly  202  is depicted in proper arrangement and position. 
         [0082]    Mask assembly  202  is a full mask type assembly of the type typically used in PAP type therapy and has a flexible silicone seal  204 , with said seal fitted against the face of the user to prevent significant air leakage while air is being delivered under pressure by a PAP type unit to mask assembly  202 . Mask assembly  202  has an attachable and removable headgear assembly  206  connected to it. Headgear assembly  206  has an integral lower headgear strap  208  which is arranged and positioned to pass through and be restrained in headgear strap channel  209  wherein pad  200  is positioned to permit such an arrangement and positioning of lower headgear strap  208  across top plate  210  and into and through headgear strap channel  212  (shown in  FIG. 13 ). Headgear assembly  206  includes an upper headgear strap  214  which is attachable to the upper part of mask assembly  202 . 
         [0083]    As shown in  FIG. 12 , pad  200  is arranged and positioned such that the upper face side  220  of pad  200  makes contact beneath the zygomatic bone  230  and the lower face side  232  of pad  200  makes contact with above the lower mandible  236 . This particular arrangement and positioning of pad  200  allows it to be cradled and supported by lower headgear strap  208  to thereby provide stability for the assembly while it is being used during PAP type therapy. This arrangement and positioning depicted in  FIG. 12  also can provide some side support for a portion of seal  204  of face mask assembly  202  if properly arranged and positioned up against it on the cheek side of seal  204 , thereby helping to provide for good and reliable sealing at that point of contact between seal  204  and the CD assembly. The compressibility of pad  200  to conform to the morphology and structure of the side of the face where it is placed, optimally providing light contact between the cheek with the teeth and gums, can provide stability, comfort and effective function of the cheek depressor by allowing the contact of the compressed pad against the cheek to provide adequate depression of the cheek without abrading, bruising or harming the gums, teeth or inside of the cheek, thus preventing significant cheek movement from the depressed position during exhalation. When suitably arranged and positioned, the CD assembly can depress the cheeks effectively to reduce or eliminate a significant air accumulator effect in the mouth cavity of the user which occurs when the cheeks are not depressed during the use of a PAP type unit. 
         [0084]      FIGS. 13-14  illustrate one embodiment of cheek depressing pad  200 . Use of strap retainer  250  and strap retainer  252  affixed to top plate  210  provides a headgear strap channel  212  which will contain and hold a lower headgear strap  208 , while at the same time allowing lower headgear strap  208  to be adjusted or positioned whereby it can be pulled back and forth or through headgear strap channel  212  ( FIG. 14 ), or pulled out of or placed into headgear channel  212 , while otherwise being able to hold lower headgear strap  208  stable when not being adjusted or positioned. Pad  200  has a face side  260  for contact with the face of the device user as shown in  FIG. 14 .  FIG. 14  shows pad  200  to have an upper face side  220  and a lower face side  232 , and a pad center  262 , which are compressible against a cheek bone (just below zygomatic bone)  230  and above the jawbone (mandible)  236  of a user when the CD assembly is properly arranged and positioned. 
         [0085]      FIG. 15  shows another embodiment of cheek-engaging pad  200  as it will typically appear in approximate compressed form when cradled under the cheekbone (zygomatic bone) and above the jaw bone. This depiction is an approximation and any actual compression of pad  200  may vary somewhat from this without departing from this novel art.  FIG. 15  shows an estimated side view depiction of pad  200  with an uncompressed outline  270  of pad  200  shown in comparison to a compressed outline  272  of pad  200 . Compressed outline  272  is the result of placing the CD assembly in proper arrangement and position in relation to lower headgear strap  208 , to facemask assembly  202  and to the user (see  FIG. 12 ) with proper tensioning of lower headgear strap  208 . 
         [0086]    The use of a pre-molded integral cheek depressor such as CD assembly  300  of  FIG. 16  is an alternative way to provide a cheek depressor, one which has an integral pad perimeter such as that shown in  FIG. 16  as pad perimeter  302 . Because pad perimeter  302  is pre-formed it can make contact under the cheek bone and upon the jaw bone to provide a suitable and yet comfortable support for a pad center which is thicker, such as pad center  304 , which is centered to the approximate center of the cheek for depressing the cheek. Use of this pre-molded bi-level CD assembly  300  of  FIG. 16  can provide good depression of the user&#39;s cheek in an overall thinner unit. When CD assembly  300  is properly arranged and positioned, CD assembly  300  prevents or minimizes an air accumulator effect which can occur without the cheeks being effectively depressed. 
         [0087]    The CD assembly  300  of  FIG. 16  includes support plate  310 , which can be comprised of a single piece of molded plastic, composite, sheet metal or any other appropriate substance which is free of sharp corners and/or burrs which could wear through or cut through the foam material molded around it, CD assembly  300  is formed with a single piece of foam of plastic or rubber type molded around this support plate by using a mold as is known in the art of plastic or rubber molding, using a material which will be somewhat compressible when properly arranged and positioned on a user. In this case, after CD assembly  300  has been molded it is dipped in a thin plastic compound to provide a smooth sealed surface coating as is also known in the art. CD assembly  300  has a pre-molded integral bi-level pad  312 , is provided with a pad perimeter  302  for contact under the cheek bone (zygomatic bone) and above the jaw bone (mandible), and will be placed at an approximate cheek center. 
         [0088]    Pad center  304  provides for depressing the cheek effectively and keeping it depressed while, for example, a PAP type unit is operated without causing abrading, bruising or damage to the cheek, gums or upper or lower jaw. CD assembly  300  has a headgear strap retainer  316  and a headgear strap retainer  318  also molded integral to it, thus providing a headgear strap channel  320  for a lower headgear strap  208  of  FIG. 12 , in this way, lower headgear strap  208  of  FIG. 12  can be retained securely while the user loosens or adjusts lower headgear strap  208  or removes lower headgear strap  208  from mask assembly  202  in order to remove mask assembly  202  of  FIG. 12 . This allows removal, storage or re-fitting of mask assembly  204  by and from user without lower strap  208  coming loose from headgear strap channel  320  unless the user chooses to pull it out of headgear strap channel  320 . Headgear strap channel  320  allows the easy adjustment of the lower strap during use. 
         [0089]    Other embodiments of a cheek depressor may include semi-spherical elements that are coupled to one or more straps of a PAP mask. The semi-spherical elements may include portions of different compressibility to improve fit or efficacy of the cheek depressor. The semi-spherical cheek depressors can be solid or liquid filled. 
         [0090]    CD assembly  300  can be custom molded to an impression taken of the face using any of a number of available means, including but not limited to compressible foam plastic non rebounding molding such as that used for making impressions of the bottom side of the foot by orthotic technicians and podiatrists. CD assembly  300  can alternatively be pre molded in several distinct prearranged standard sizes thus allowing the individual selection of a pre-molded CD assembly  300  at the time of fitting to avoid any waiting times for a custom molded order. Either method, premade standard sizes or a custom molded method, can provide for a very good and very comfortable fit without much compression of the pad  312  needed, thus allowing pad perimeter  302  and pad center  304  to be thinner than otherwise possible. And it is also possible to pre-mold and/or construct pad  312  in different stiffnesses, such as a somewhat thinner stiffer pad perimeter  302  and a thicker, softer, somewhat more compressible pad center  304  in order to provide pad center  304  with a mildly compressible but thicker foam for maximum comfort at the cheek when it is depressed. 
         [0091]      FIG. 17  is a front view of another embodiment of the invention, a CD assembly  400 . CD assembly  400  is comprised of a pair of molded silicone pads  402 , which are suitably fastened to the bottom ends of a yoke  404  which ideally should have spring like properties being able to rebound to its starting shape While holding tension when displaced to a more open position. In this case yoke  404  has an outside cover constructed of a nylon plastic type compound to which a formed and pre-stressed steel spring is molded inside (not shown). The pair of pads  402  can be suitably attached to the ends, one each, of yoke  404  by insertion into orifices molded into the pair of pads  402 . There are no sharp edges anywhere on yoke  404  or either of the pair of pads  402 . CD assembly  400  is placed in proper position over the head and each of the pair of pads  402  is adjusted by moving them up or down on yoke  404  to place them at proper position of the approximate center of each cheek. Proper thickness of the pair of pads  402  can be selected to provide adequate tension against each cheek. It is also easy to manufacture this freestanding embodiment as a very simple singly molded piece out of a plastic composite with good support strength, spring characteristics and memory. Carbon fiber, which has many benefits such as strength and lightness, can also be used. 
         [0092]      FIG. 18  shows CD assembly  400  properly placed and positioned on a patient&#39;s head. Yoke  404  may be constructed of various desirable high tensile strength metal alloys or plastic compounds which are light and comfortable to use. Of course a pad can be arranged at the sides and/or top of yoke  404  to increase the comfort of the patient. 
         [0093]    The actual CDs can be made very compact for easy application to use by musicians or those engaging in various sports, organized and individual, which may include exercising, jogging or swimming. This embodiment can be custom made to provide a very compact streamlined fit and still be able to enhance exhalation for musicians or respiration in general for those engaging in physical exercise. The CD assembly of this embodiment may prove over time to be useful in various professional and amateur sports as an enhancement to conditioning and performance. This embodiment of the CD assembly offers great flexibility for a wide variety of applications, medical and non medical including but not limited to individual and team sports, the playing of musical instruments powered by exhalation and other uses which will utilize the benefits of enhanced inhalation and/or exhalation. For some individual users, the CD assembly must not necessarily be placed at the approximate center of each cheek to attain a benefit of enhanced inhalation and/or exhalation. For example some individuals seem to respond well when the CD assembly is placed at the upper part of the cheeks and the pads are of smaller size. 
         [0094]      FIG. 19  illustrates another embodiment of the present invention including a telescoping yoke  400  with a pair of pad assemblies  402  secured at ends of yoke  400 . Pad assembly  402  includes a pair of pad portions  406 ,  408 . Pad portion  406  can be substantially softer (more compressible) than pad portion  408 . Pad portion  408  is optimally positioned at the target area of the user. Telescoping couplers  410  are provided to adjust the fit of yoke  400 . 
         [0095]    Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.