Sleep disordered breathing, including snoring and obstructive sleep apnea, affects tens of millions of adults in the United States. It is associated with substantial cardiovascular morbidity and mortality, endocrine disturbances, excessive daytime sleepiness, quality of life and performance deficits, and motor vehicle crashes.
Multiple factors contribute to sleep disordered breathing, including the decrease in muscle tone that occurs with sleep onset. The breathing passages of the upper airway, including the nose, oral cavity, and pharynx, are surrounded by muscles and other soft tissues of the head and neck. This decrease in muscle tone enables collapse or vibration of these soft tissues, particularly in the oral cavity and pharynx, contributing to sleep disordered breathing. Treatment of sleep disordered breathing includes approaches that directly or indirectly enlarge or stabilize the breathing passages of the upper airway. Treatment options include behavioral measures such as weight loss, positive airway pressure therapy, surgery, and oral appliances. All treatments have strengths and weaknesses, whether limited compliance, risks of complications, or outcomes that can vary widely.
Head and neck exercises have been proposed as an alternative treatment for sleep disordered breathing. These isotonic and/or isometric exercises can involve muscles within and surrounding the oral cavity and/or pharynx. A number of the exercises that have been proposed may include the generation of positive or negative pressure within the oral cavity and/or pharynx. A number of the exercises may include movement of the tongue.
A method for performing a breathing exercise includes positioning an open portion of a member to a user's nose such that breathing by the user through the open portion creates a continuous air pathway from the nose to lungs of the user. The method also includes performing the breathing exercise in a manner such that the user repeatedly generates a pressure within the open portion that produces an airflow against an airflow resistance determined by an airflow resistance mechanism.
A method for performing a breathing exercise includes positioning an open portion of a member to a user's nose such that breathing by the user through the open portion creates a continuous air pathway from the nose to lungs of the user. The method also includes performing the breathing exercise in a manner such that the user repeatedly generates a pressure within the open portion that produces an airflow rate against an airflow resistance determined by an airflow resistance mechanism.
As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to employ variously the present invention.
Referring to all Figures and embodiments described in this application, similarly-numbered parts (e.g., 118, 318, 418, etc.) may have similar descriptions, designs, and embodiments.
Referring to
The head and neck exercise apparatus 110 may include a member 114. In this embodiment, the member 114 is generally cylindrically-shaped with a proximal interface 112 having a similar general shape with a lesser diameter. The member 114 may define a passageway or proximal portion 122 there through. The proximal interface 112 may be positioned to a user's mouth or connected to another interface component that could permit a user to position the head and neck exercise apparatus 110 to a part of a user's head and neck such as the nose and/or the mouth. In this embodiment, the member 114 also defines a passageway or distal portion 124 there through. In other embodiments, the distal interface 115 may be positioned to a user's mouth or connected to another interface component that could permit a user to position the head and neck exercise apparatus 110 to a part of a user's head and neck such as the nose and/or the mouth. In other embodiments, the member 114, proximal interface 112, and other components may have different general shapes and sizes. In other embodiments, there may be zero or more than one proximal interface 112 and/or distal interface 115.
The member 114 may be considered a housing, within which there may be additional components of the head and neck exercise apparatus 110 or at least one component of at least one other head and neck exercise apparatus. A valve plate 116 may be operatively arranged with (e.g., disposed within, connected to, etc.) the member 114. The valve plate may cooperate with at least one valve mechanism 118 that is positioned within a valve stem hole 119; collectively, this may be defined as a valve plate assembly. In this embodiment, the valve plate 116 contains four valve stem holes 119, through which a valve mechanism 118 is positioned in each of them; of the four valve mechanisms 118, two are oriented in each direction. The valve plate 116 may separate the proximal portion 122 and distal portion 124 when all valve mechanisms 118 are in the closed position. A tamper guard 120 may be positioned to help shield the valve plate 116 and valve mechanisms 118 from physical contact.
In certain embodiments, the valve mechanisms 118 are biased towards the closed position unless at least one valve mechanism 118 is opened when the positive pressure in the proximal portion 122 is greater than a threshold pressure (e.g., 0.5 pounds per square inch), such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.), valve plate 116 (e.g., thickness, etc.), and/or at least one valve mechanism 118 (e.g., stiffness, thickness, etc.). For example, if the pressure in the proximal portion 122 rises above the threshold pressure to open the at least one valve mechanism 118 but subsequently falls below the threshold pressure, the at least one valve mechanism 118 closes.
In this embodiment, because two valves are oriented in each direction, at least one valve mechanism 118 (but not more than two valve mechanisms 118) is opened when the positive pressure is greater than the threshold positive pressure of the respective valve mechanisms, such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.), valve plate 116 (e.g., thickness, etc.), and/or valve mechanism 118 (e.g., stiffness, thickness, etc.). Similarly, in this embodiment at least one different valve mechanism 118 (but not more than two different valve mechanisms 118) is opened when the absolute value of the negative pressure (hereafter, “absolute negative pressure” or “negative pressure”) in the proximal portion 122 is greater than an absolute value of a threshold negative pressure (hereafter, “absolute threshold negative pressure” or “threshold negative pressure”, e.g., 0.5 pounds per square inch), such threshold negative pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.), valve plate 116 (e.g., thickness, etc.), and/or valve mechanism 118 (e.g., stiffness, thickness, etc.). For example, if the negative pressure in the proximal portion 122 rises above the threshold negative pressure to open at least one valve mechanism 118 but subsequently falls below the threshold negative pressure, the at least one valve mechanism 118 closes.
In this application, unless specified otherwise, “pressure” hereafter refers to the magnitude of pressure, whether the absolute positive pressure or absolute negative pressure, and “threshold pressure” refers to the magnitude of pressure, whether threshold positive pressure or threshold negative pressure.
In this embodiment, each valve mechanism 118 individually has a threshold pressure that may be positive or negative pressure, but in other embodiments a valve mechanism may have a threshold positive pressure and a threshold negative pressure.
In this embodiment, the valve mechanisms 118 are substantially the same, but they could differ. The threshold pressure associated with positive pressure in the proximal portion 122 for opening the at least one valve mechanism 118 may differ from the threshold pressure associated with negative pressure in the proximal portion 122 for opening the at least one valve mechanism 118, even for the same head and neck exercise apparatus 110. All other embodiments described for positive pressure in the proximal portion could be configured for negative pressure.
When at least one valve mechanism 118 is open, the proximal portion 122 is fluidly connected to the distal portion 124, and airflow may occur between the proximal portion 122 and the distal portion 124 though at least one airflow channel 126. In this embodiment, the at least one valve mechanism 118 is presented as of the umbrella valve type; each at least one valve mechanism 118 forms a seal by extending beyond the associated airflow channels 126, thereby separating the proximal portion 122 from the distal portion 124 when the at least one valve mechanism 118 is closed. Airflow may occur, for example, from the proximal portion 122 to distal portion 124 with a head and neck exercise that requires generation of positive pressure in the proximal portion 122, if the positive pressure exceeds the threshold pressure, thereby opening the at least one valve mechanism 118 to permit airflow through at least one airflow channel 126 associated with the at least one valve mechanism 118. The threshold pressure of the at least one valve mechanism 118 may be associated with the construction and features of the valve mechanism 118 and/or properties of other components (valve plate 116, member 114, tamper guard 120, etc.) of the head and neck exercise apparatus 110. For a valve mechanism 118 of the umbrella valve type, the threshold pressure of the valve mechanism 118 would generally be greater with greater thickness of the valve plate 116. For this head and neck exercise using the head and neck exercise apparatus 110, this airflow could provide simple and immediate user feedback to indicate that the pressure (positive pressure or absolute negative pressure, with different directions of airflow for each) in the proximal portion 122 was greater than the relevant threshold pressure.
In other embodiments, the at least one valve mechanism 118 may open if the pressure in the proximal portion 122 rises above the threshold pressure but then remain open if the pressure in the proximal portion 122 subsequently falls below the threshold pressure. The valve mechanism may include some means to return the valve to the closed position (e.g., reset lever, etc.). In other embodiments, the valve mechanism 118 may be biased towards the open position unless it is closed when the pressure in the proximal portion 122 is greater than a threshold pressure, with all other potential configurations described elsewhere in this application.
Apparatuses for head and neck exercises for sleep disordered breathing ideally provide feedback regarding proper performance of the exercises. As opposed to traditional muscle strength and/or endurance training exercises where gross body movements enable monitoring of the exercise, a user does not easily visualize some head and neck muscles during movement or contraction. Feedback from an apparatus for head and neck exercises for sleep disordered breathing may indicate correct movements or muscle contractions through a number of means, including those that depend on generation of positive pressure or negative pressure within the nose, oral cavity, and/or pharynx of a sufficient magnitude (absolute pressure) or duration.
User feedback could be based on airflow through an apparatus, any sensory signal (visual, auditory, or tactile), and/or objective measurement that may provide data in real-time or in a delayed fashion (e.g, with recording or transmission). The simplicity of the valve mechanism 118 avoids the need for a pressure transducer or other means that may be complex or expensive, as in many medical apparatuses that may emphasize precision over simplicity and low cost. Simplicity and low cost are more important for head and neck exercises for sleep disordered breathing than in most medical applications. For example, a user may perform these exercises in a wide range of settings over a period of time, where inexpensive and easily portable apparatuses would be favored. In other embodiments, the head and neck exercise apparatus 110 may include a mechanism for substitution of at least one of the valve plate 116 and/or at least one valve mechanism 118; substitution could provide additional benefits, including decreased cost. Sensory signals are well-known in the art and could be incorporated into the head and neck exercise apparatus 110. Objective measurements may relate to the act of performance of the exercise (e.g., adherence to an exercise regimen, etc.) or the nature of the performance (e.g., pressure transducer, etc.). Objective measurements may be recorded in the head and neck exercise apparatus or transmitted (wired, wireless, etc.) for evaluation in real-time or a delayed fashion, with or without storage of the data.
A head and neck exercise system may include at least one head and neck exercise apparatus with at least one threshold pressure or airflow resistance that is adjustable or at least two head and neck exercise apparatuses, each with at least one threshold pressure that may be adjustable or not adjustable. The threshold pressure or airflow resistance may be adjustable or variable during the performance of the head and neck exercise. The head and neck exercise system could be designed to provide a range of threshold pressures for the performance of head and neck exercises. Selection of a threshold pressure for performance of a head and neck exercise may be based on one of more factors, including an ability of the user to perform the head and neck exercise or a different head and neck exercise, using the head and neck exercise apparatus 110 or another head and neck exercise apparatus, with the threshold pressure or another threshold pressure, for a number of repetitions or duration of time or with a muscle strength or a muscle tension required to perform the head and neck exercise using the head and neck exercise apparatus, the another head and neck exercise apparatus, or a different head and neck exercise apparatus. Assessment for selecting a threshold pressure may involve one or more types of head and neck exercise apparatuses, and an apparatus used specifically for testing muscle strength or tension may be considered one type of head and neck exercise apparatus.
A number of respiratory apparatuses used in medical environments are capable of monitoring positive pressure or negative pressure, but these may not be well-suited to the performance of these head and neck exercises for sleep disordered breathing. Respiratory apparatuses are often developed for disorders affecting the lungs rather than the nose, oral cavity, and/or pharynx. This leads to features, such as freely permitting airflow through the apparatus (in order to monitor airflow without disturbance), that may be unfavorable for some head and neck exercises for sleep disordered breathing. These apparatuses or their feedback mechanisms may be expensive or complex, require electrical parts, or be designed to offer precision in measurements of pressure or airflow. These features may not be necessary with exercises for sleep disordered breathing. These and other limitations may have prevented the use of respiratory apparatuses in head and neck exercises for sleep disordered breathing and treatment of many other conditions.
Exercise apparatuses used in other areas of the body (for example, including weights) have been adapted for use in the head and neck region, but their uses have generally been limited to strengthening muscles for chewing or teeth clenching that may not be suited to exercises for sleep disordered breathing. The unique nature of head and neck exercises for sleep disordered breathing requires different apparatus designs.
Three types of apparatuses have been proposed for head and neck exercises for sleep disordered breathing: (1) brushes or apparatuses with a roughly linear, solid design that can stroke or brush the tongue; (2) tubes designed for drawing liquid from a container connected to a pressure transducer; and (3) positive end-expiratory pressure relief valves utilizing a coil spring mechanism. There are a number of limitations of these apparatuses. The first type is not designed for resistance training exercises and does not provide meaningful feedback regarding many of these exercises. The second is unnecessarily complex and expensive, which may not be favorable for many reasons, including those outlined above.
Positive end expiratory pressure relief valves placed to the mouth have been proposed for use during exercise or for expiratory muscle training, primarily for disorders affecting the lungs such as chronic obstructive pulmonary disease. These apparatuses provide resistance training for the chest wall muscles relevant to these pulmonary disorders, and the threshold pressure level may be determined by a coil spring mechanism that enables adjustment over a wide (and continuous) range. These apparatuses have a number of limitations for the treatment of sleep disordered breathing. First, they have been used largely in expiration only. In addition, placement to the mouth may train muscles associated with oral breathing, but placement to the nose may train muscles associated with nasal breathing that may be generally more favorable in patients with sleep disordered breathing.
These devices may be well-suited to chronic obstructive pulmonary disease in which an exercise program generally consists of a single exercise, but exercises for sleep disordered breathing typically involve more than one exercise. With multiple exercises, complexity (e.g., a single apparatus with a threshold pressure that must be adjusted) may not be favorable. In contrast, a selected range of similar apparatuses with different threshold pressures may be more straightforward and may enable the construction of simpler apparatuses. There are other limitations and drawbacks of apparatuses that are available currently.
The valve mechanism 118 may have any design that performs the functions as specified. In other embodiments, the valve mechanism 118 may contain at least two components. In other embodiments, the valve mechanism 118 may have a means of adjustment (application of pressure to a portion, placement of a foreign material in the valve stem, etc.) to alter its properties (e.g., dimensions, resistance to opening, etc.). Adjustment of the threshold pressure of the valve mechanism 118 may enable a head and neck exercise apparatus 110 to encompass a wider range of threshold pressures and reduce the number of apparatuses that would be incorporated into an exercise program. However, there also may be greater complexity, including challenges in ensuring that the adjustment provides precise and/or accurate performance characteristics (threshold pressure, etc.).
In other embodiments, the valve mechanism 118 may be configured to respond both to positive and to negative pressure. In other embodiments, the head and neck exercise apparatus 110 may be configured to allow substitution of the valve mechanism 118. In other embodiments, the member 114 may have no distal portion 124, enabling the proximal portion 122 to communicate directly to the external environment when the valve mechanism 118 is open.
In this embodiment, the valve mechanisms 118 are distinct from the valve plate 116, but in other embodiments any component of at least one valve mechanism 118 may be manufactured in continuity with any part of the valve plate 116 or head and neck apparatus 110.
A single physical device or member can function as at least two head and neck exercise apparatuses 110, whether for a single head and neck exercise or for at least two head and neck exercises. In addition to the differences that exist for at least two head and neck exercises, there are multiple means by which this may occur: adjustment and/or substitution of at least one valve mechanism 118, different orientations of at least one valve mechanism 118, positioning the proximal interface 112 and/or distal interface 115 to the nose and/or mouth (without and/or with the use of a mask interface), etc. Adjustment or substitution of a valve mechanism 118 or other component may modify the threshold pressure and be considered a modification, just as the ability of a valve mechanism 118 to be adjusted or substituted may be considered modifiable. A single physical device functioning as at least two head and neck exercise apparatuses may provide lesser cost, lesser complexity, or other benefits.
A method for performing breathing exercises with a breathing exercise system including at least one breathing apparatus may comprise positioning a member defining an open proximal portion to a nose of a user such that breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of a throat of the user behind the soft palate to create a continuous air pathway from the nose to lungs of the user; performing by the user a first breathing exercise via the continuous air pathway in which the user generates, for a predetermined number of repetitions or duration of time, a pressure within the open portion of the apparatus that exceeds a threshold pressure of a valve mechanism biased towards a closed position to cause the valve mechanism to open such that the open proximal portion is fluidly connected to a distal portion and the lungs to train muscles of the user; positioning the open proximal portion of the member to a nose of a user such that breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of a throat of the user behind the soft palate to create a continuous air pathway from the nose to lungs of the user; and performing by the user the second breathing exercise via the continuous air pathway in which the user generates, for a predetermined number of repetitions or duration of time, a pressure within the open proximal portion that exceeds a threshold pressure of a valve mechanism biased towards a closed position to cause the valve mechanism to open such that the open proximal portion is fluidly connected to the distal portion and the lungs to train muscles of the user.
The proximal interface 112 may be placed between the lips such that it extends inside the oral cavity to assist with maintaining the apparatus position or achieving an airtight communication with the oral cavity. The proximal interface 112 may be of any configuration or placement (to the nose, to the lips, between the lips, inside the cheeks, between the teeth, above the tongue, etc.). The proximal interface 112 may be configured to favor an orientation of at least one structure of the face or oral cavity. A mask interface, mouthpiece, or other component may cooperate with the proximal interface 112 to facilitate the placement against a portion of the head and neck of the user. Such an orientation could be desirable in the performance of head and neck exercises for sleep disordered breathing.
In this embodiment, the proximal interface 112 is manufactured in continuity with the member 114. In other embodiments, the proximal interface 112 may be separable from the member 114. In these embodiments, the proximal interface 112 and member 114 may have a coupling element, with a possible mechanism to enhance their cooperation, such as a locking or snap mechanism. In other embodiments, any suitable proximal interface 112 or design of the member 114 may be used as an interface between the user and apparatus.
The head and neck exercise apparatus 110 may be configured with a mechanism to sense pressure in the proximal portion 122 and/or distal portion 124. The head and neck exercise apparatus 110 may be configured with a means for transmission of real-time or stored data (e.g., exercise performance, pressure, etc.).
Referring to
One goal of treating sleep disordered breathing is maintaining a patent upper airway, enabling a continuous air pathway from the nose to the lungs. Breathing through the nose may result in anterior movement of the soft palate to open the space for breathing in the area of the throat behind the soft palate, whereas breathing through the mouth may result in posterior movement of the soft palate to open the space for breathing between the tongue and soft palate. This may be particularly true for performance of head and neck exercises involving active breathing through the nose vs. mouth. Breathing through the nose may also involve closure of the space between the tongue and soft palate. Breathing through the mouth may also narrow the space for breathing in the throat directly or indirectly, as compared to breathing through the nose; mechanisms may include posterior displacement of the tongue, decrease in stretch and/or tension of the soft tissues surrounding the throat, loss of nasal airflow that may provide sensory input to neuromuscular reflexes important in maintaining a patent upper airway, and/or other sources of increased upper airway collapsibility.
For purposes of this application, positioning a head and neck exercise apparatus “to the user's nose” encompasses positioning to the nose (for breathing through the nose alone) or positioning to the nose and mouth (for breathing through the nose and mouth).
The mask interface may reversibly or irreversibly cooperate with the member 214 at the proximal interface 212. A coupling mechanism, such as a locking or snap mechanism, may facilitate this cooperation. A reversible cooperation may allow the member 214 to cooperate with different mask interfaces. A reversible cooperation may also allow the mask interface to cooperate with the member 214 of different head and neck exercise apparatuses 210 that may have different properties. Cooperation with the member 214 of different head and neck exercise apparatuses 210 could enable an user to perform head and neck exercises for sleep disordered breathing using apparatuses with a range of threshold pressures that could be desirable. An exercise program may incorporate exercises that require different threshold pressures, and the use of head and neck exercise apparatuses 210 with a range of threshold pressures or multiple apparatuses would reduce the need for adjustment or calibration of any single head and neck exercise apparatus 210. Adjustment and calibration can introduce cost, complexity, and expenditure of time and effort, any of which may be undesirable.
In this embodiment, the mask interfaces are distinct from the head and neck exercise apparatus, but in other embodiments any component of the mask interface may be manufactured in continuity with any part of the head and neck exercise apparatus 210. In this embodiment, the mask interfaces cooperate with the member at the proximal interface 212. In other embodiments, a mask interface may connect directly to the member 214 without a proximal interface 212, or the mask interface may cooperate with the head and neck exercise apparatus 210 at the distal interface 215.
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The valve mechanisms 118 (
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The present embodiment includes two spring valve mechanisms 818 that open specifically to positive or negative pressure, but in other embodiments at least one spring valve mechanism 818 with a different configuration could open in response to either positive or negative pressure in the proximal portion of the member 814.
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The proximal valve assembly spring 971E and distal valve assembly spring 971F may maintain the proximal valve assembly plate 971B and distal valve assembly plate 971D, respectively, in positions at rest that bias the valve assembly 971 towards an open position. At rest, the proximal valve assembly spring 971E and distal valve assembly spring 971F may contact the middle valve assembly plate 971C that is in a stable position within the valve assembly 971. In this embodiment, the proximal valve assembly spring 971E and distal valve assembly spring 971F are presented as of the compression spring type, but other spring types (e.g., extension, torsion, disk, etc.) are possible. Multiple spring types may be used in any combination within the same apparatus, housing, or system.
In this embodiment, the valve assembly 971 may be biased towards the open position unless it is closed when the positive pressure in a proximal portion 922 is greater than a threshold pressure, with all other potential configurations described elsewhere in this application. When the positive pressure in the proximal portion 922 is greater than a threshold pressure, the proximal valve assembly plate 971B may be displaced towards the middle valve assembly plate 971C, and the proximal valve assembly plate 971B may form a seal against the valve assembly housing 971A to close the valve assembly 971 (
Similarly, in this embodiment the valve assembly 971 may be biased towards the open position unless it is closed when the negative pressure in the proximal portion 922 is greater than another threshold pressure. When the negative pressure in the proximal portion 922 is greater than the another threshold pressure, the distal valve assembly plate 971D may be displaced towards the middle valve assembly plate 971C, and the distal valve assembly plate 971D may form a seal against the valve assembly housing 971A to close the valve assembly 971 (
The threshold pressures of the valve assembly 971 may be associated with the construction and features of the valve assembly 971, the components of the valve assembly 971, and/or properties of other components (member 914, tamper guard 920, etc.) of the head and neck exercise apparatus 910.
In this embodiment, the valve assembly is presented as of the plug valve type, but other valve types (shut-off valve, valve with spring elements, flap valve, etc.) are possible.
Referring to
The proximal valve assembly spring 1071E may maintain the proximal valve assembly plate 1071B in a position at rest that biases the valve assembly 1071 towards an open position. At rest, the proximal valve assembly spring 1071E may contact the middle valve assembly plate 1071C that may be in a stable position within the valve assembly 1071.
In this embodiment, the valve assembly 1071 may be biased towards the open position unless it is closed when the positive pressure in a proximal portion 1022 is greater than a threshold pressure, with all other potential configurations described elsewhere in this application. When the positive pressure in the proximal portion 1022 is greater than a threshold pressure, the proximal valve assembly plate 1071B may be displaced towards the middle valve assembly plate 1071C, and the proximal valve assembly plate 1071B may form a seal against the valve assembly housing 1071A to close the valve assembly 1071 (
The threshold pressures of the valve assembly 1071 may be associated with the construction and features of the valve assembly 1071, the components of the valve assembly 1071, and/or properties of other components of the head and neck exercise apparatus.
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Separately, the proximal valve plate 1317 and distal valve plate 1321 may each cooperate with at least one accessory valve mechanism 1309. The at least one accessory valve mechanism 1309 may be oriented to allow airflow through the respective plate when at least one valve mechanism 1318 in the opposite valve plate is open; for example, if the pressure in the proximal portion 1322 is greater than a threshold pressure, airflow may occur from the proximal portion 1322 to the distal portion 1324 by traveling through at least one accessory valve mechanism 1309 in the proximal valve plate 1317 and then through airflow channels 1326 in the distal valve plate 1321 associated with the at least one valve mechanism 1318 that is open. In this embodiment, the threshold pressure of the head and neck exercise apparatus may be primarily defined by the at least one valve mechanism 1318 because the threshold pressure of the accessory valve mechanism 1309 is low, but in other embodiments the accessory valve mechanism 1309 may have any threshold pressure.
The valve plate adjustment mechanism 1313 may be configured to control a separation distance between the proximal valve plate 1317 and distal valve plate 1321. The threshold pressure of the at least one valve mechanism 1318 may be associated with the separation distance between the proximal valve plate 1317 and distal valve plate 1321. The threshold pressure of the at least one valve mechanism 1318 may be associated with the construction and features of the at least one valve mechanism 1318 and/or properties of other components (proximal valve plate 1317, distal valve plate 1321, valve plate adjustment mechanism 1313, member 1314, tamper guard 1320, etc.) of the head and neck exercise apparatus 1310. The valve plate adjustment mechanism 1313 may cooperate with an end stop to limit relative movement of the proximal valve plate 1317 and/or the distal valve plate 1321. In the present embodiment, the valve plate adjustment mechanism 1313 may be rotated in its position to adjust the separation distance. In this embodiment, the proximal valve plate 1317 is fixed in position, while the position of the distal valve plate 1321 is controlled by the valve plate adjustment mechanism 1313; in other embodiments, the proximal valve plate 1317 and distal valve plate 1321 may each be in a fixed or variable position. In this embodiment, the valve plate adjustment mechanism 1313 has two components: the adjustment portion 1301 and adjustment mechanism cap 1303, but the valve plate adjustment mechanism 1313 may be configured as a single component or any number of components. The valve plate adjustment mechanism 1313 may contact the proximal valve plate 1317 and/or the distal valve plate 1321 with flat portions that correspond to specific separation distances (as in this embodiment) or with a rounded contour; the nature of the contact surface may be associated with the means of adjustment of threshold pressure (e.g., rounded contour for gradual adjustment vs. flat portions for discrete levels of threshold pressure, etc.). There may be a biasing means, such as a coil spring, urging at least one of the proximal valve plate 1317 or distal valve plate 1321 towards each other.
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A proximal valve plate 1617, distal valve plate 1621, and valve plate adjustment element 1623 may be operatively arranged with (e.g., disposed within, connected to, etc.) the member 1614. The proximal valve plate 1617 and distal valve plate 1621 may separate the proximal portion 1622 and distal portion 1624 when all valve mechanisms 1618 are in the closed position. A valve plate adjustment element 1623 may be configured to control a separation distance between the proximal valve plate 1617 and distal valve plate 1621. In this embodiment, the proximal valve plate is in a fixed position while the distal valve plate 1621 is in a variable position, but other permutations are possible. In this embodiment, the plate adjustment element 1623 may cooperate with a proximal valve plate adjustment interface 1673 and distal plate adjustment interface 1689; the cooperation with the proximal valve plate adjustment interface 1673 may stabilize the plate adjustment element 1623, while the cooperation with the distal plate adjustment interface 1689 may enable control of the plate adjustment element 1623 to control the position of the distal valve plate 1621. The valve plate adjustment element 1623 may be configured to have discrete settings associated with specific separation distances or enable continuous adjustment. The valve plate adjustment element 1623 may cooperate with an end stop to limit relative movement of the proximal valve plate 1617 and/or the distal valve plate 1621. In the present embodiment, the valve plate adjustment element 1623 adjusts the position of the distal valve plate 1621, but in other embodiments it could adjust the position of the proximal valve plate 1617 and/or distal valve plate 1621. In the present embodiment, the valve plate adjustment element 1623 is connected to an end cap 1625 that enables a user to select settings that correspond to separation distances. The end cap 1625 also may be configured to include features of a tamper guard, as in the present embodiment, or there may be a separate tamper guard.
The threshold pressure of the at least one valve mechanism 1618 may be associated with the separation distance between the proximal valve plate 1617 and distal valve plate 1621. The threshold pressure of the at least one valve mechanism 1618 may be associated with the construction and features of the at least one valve mechanism 1618 and/or properties of other components (proximal valve plate 1617, distal valve plate 1621, valve plate adjustment element 1623, member 1614, tamper guard 1620, etc.) of the head and neck exercise apparatus 1610.
Separately, the proximal valve plate 1617 and distal valve plate 1621 may each cooperate with at least one accessory valve mechanism 1609. The at least one accessory valve mechanism 1609 may be oriented to allow airflow through the respective plate when at least one valve mechanism 1618 in the opposite valve plate is open; for example, if the pressure in the proximal portion 1622 is greater than a threshold pressure, airflow may occur from the proximal portion 1622 to the distal portion 1624 by traveling through at least one accessory valve mechanism 1609 in the proximal valve plate 1617 and then through airflow channels 1626 in the distal valve plate 1621 associated with the at least one valve mechanism 1618 that is open. In this embodiment, the threshold pressure of the head and neck exercise apparatus is primarily defined by the at least one valve mechanism 1618 because the threshold pressure of the accessory valve mechanism 1609 is low, but in other embodiments the accessory valve mechanism 1609 may have any threshold pressure.
In this embodiment, each valve mechanism 1618 is oriented in a specific direction, such that it will only permit airflow in a specific direction. For a valve mechanism 1618 oriented to permit airflow from the proximal portion 1622 to the distal portion 1624, no airflow will occur from the opposite direction (
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A coupling mechanism, such as a locking or snap mechanism, may facilitate the cooperation between the member 2014 and airflow resistance element 2011. A reversible cooperation may allow the mask interface to cooperate with the member 2014 of different head and neck exercise apparatuses 2010 that may have different properties. A reversible cooperation may also allow the member 2014 to cooperate with different airflow resistance elements 2011 (as in
Cooperation of the member 2014 with different airflow resistance elements 2011 could enable a user to perform head and neck exercises for sleep disordered breathing using a range of threshold pressures that could be desirable. An exercise program may incorporate exercises that require different threshold pressures, and the use of head and neck exercise apparatuses 2010 with a range of threshold pressures or multiple apparatuses would reduce the need for adjustment or calibration of any single head and neck exercise apparatus 2010. Adjustment and calibration can introduce cost, complexity, and expenditure of time and effort, any of which may be undesirable.
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A valve plate 2316 may be operatively arranged with (e.g., disposed within, connected to, etc.) the member 2314. The valve plate may cooperate with at least one valve mechanism 2318 that is positioned within a valve stem hole 2319. In this embodiment, the valve plate 2316 contains four valve stem holes 2319, through which a valve mechanism 2318 is positioned in each one; of the four valve mechanisms 2318, two are oriented in each direction. The valve plate 2316 may separate the proximal portion 2322 and central portion 2327 when all valve mechanisms 2318 are in the closed position.
A proximal resistance plate 2329 and distal resistance plate 2331 may be operatively arranged with (e.g., disposed within, connected to, etc.) the member 2314. The proximal resistance plate 2329 and distal resistance plate 2331 may collectively function as an airflow resistance mechanism. The proximal resistance plate 2329 may define at least one proximal resistance plate aperture 2345. The distal resistance plate 2329 may define at least one distal resistance plate aperture 2347. The size and shape of the at least one proximal resistance plate aperture 2345 and the at least one distal resistance plate aperture 2347 may be substantially the same, as in the present embodiment, but the sizes and/or shapes may differ. At least one of the proximal resistance plate 2329 and distal resistance plate 2331 may be moveable. In this embodiment, the proximal resistance plate 2329 and distal resistance plate 2331 cooperate with a resistance plate knob 2333, with the distal resistance plate 2331 configured to rotate as a means of adjusting the relative position of the proximal resistance plate 2329 and distal resistance plate 2331. The resistance plate knob 2333 may be configured to adjust the position of the distal resistance plate 2331, but other configurations are possible. A resistance indicator marker 2352 may assist the user in selection of a desired position of at least one of the proximal resistance plate 2329 and the distal resistance plate 2331. The proximal resistance plate 2329 and/or distal resistance plate 2331 may cooperate with an end stop to limit relative movement of the proximal resistance plate 2329 and/or distal resistance plate 2331. There may be a biasing means, such as a coil spring, urging at least one of the proximal resistance plate 2329 and/or distal resistance plate 2331 towards each other. In another embodiment, a biasing means could include placement of an additional resistance plate, similar to the proximal resistance plate 2329, adjacent to the distal resistance plate 2331 to sandwich the distal resistance plate 2331 between the proximal resistance plate 2329 and the additional resistance plate.
The relative position of the proximal resistance plate 2329 and distal resistance plate 2331 (collectively, an airflow resistance mechanism) may provide another mechanism to modify the threshold pressure for airflow through the head and neck exercise apparatus 2310. When the proximal resistance plate 2329 and distal resistance plate 2331 are oriented such that at least one proximal resistance plate aperture 2345 and at least one distal resistance plate aperture 2347 are not in registration, the proximal resistance plate 2329 and distal resistance plate 2331 may separate the central portion 2327 and distal portion 2324. When at least one proximal resistance plate aperture 2345 and at least one distal resistance plate aperture 2347 are in registration or partial registration, airflow may occur through the at least one common aperture, and the change in threshold pressure may be associated with the area of the total area of the at least one common aperture. The proximal resistance plate 2329 and/or distal resistance plate 2331 may be configured to have discrete settings associated with specific areas of at least one common aperture or enable continuous adjustment. The head and neck exercise apparatus 2310 may be configured to permit substitution of any or all components of the airflow resistance mechanism. Adjustment or substitution of any or all components of the airflow resistance mechanism may modify the airflow resistance.
The threshold pressure of the at least one valve mechanism 2318 may also be associated with the construction and features of the at least one valve mechanism 2318, airflow resistance mechanism, and/or properties of other components (valve plate 2316, member 2314, proximal resistance plate 2329, proximal resistance plate aperture 2345, distal resistance plate 2331, distal resistance plate aperture 2347, etc.) of the head and neck exercise apparatus 2310.
Referring to
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The head and neck exercise apparatus 2610 may include an aperture block 2635 and aperture plate 2637. The aperture block 2635 may be configured with an aperture block control 2639, such that the aperture block control 2639 may move the aperture block 2635 relative to the aperture plate 2637. The relative position of the aperture block 2635 and aperture plate 2637 may determine the characteristics (e.g., area, shape, etc.) of the space between them; this may function as an airflow resistance mechanism and provide another mechanism to modify the threshold pressures for airflow through the head and neck exercise apparatus 2610 (e.g., from the distal portion 2624 to the proximal portion 2622 with negative pressure in the proximal portion 2622). The head and neck exercise apparatus 2610 may be configured with a mechanism to determine the characteristics of the space between the aperture block 2635 and aperture plate 2637, such as an optical or magnetic encoder.
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The outer vent member 2843 and inner vent member 2844 may collectively function as an airflow resistance mechanism. The relative position of the outer vent member 2843 and inner vent member 2844 may determine the resistance to airflow of the head and neck exercise apparatus 2810. When at least one outer vent 2848 and at least one inner airflow vent 2846 are in registration or partial registration, airflow may occur through the at least one common aperture, and the resistance to airflow may be associated with area of the at least one common aperture. The resistance to airflow through the head and neck exercise apparatus 2810 may also be associated with the properties of the outer vent member 2843 (e.g., dimensions, etc.), inner vent member 2844 (e.g., dimensions, etc.), at least one outer airflow vent 2848 (e.g., dimensions, thickness, etc.), and/or at least one inner airflow vent 2846 (e.g., dimensions, thickness, etc.). The resistance to airflow through the head and neck exercise apparatus may also be associated with properties of other components of the head and neck exercise apparatus 2810 (proximal interface 2812, etc.). The proximal interface 2812, proximal portion, inner vent member 2844, distal portion, outer vent member 2843, at least one inner airflow vent 2846, and/or at least one outer airflow vent 2848 may be configured to incorporate a valve mechanism that may alter resistance to airflow. Adjustment of the relative position of the outer vent member 2843 and inner vent member 2844 or adjustment or substitution of any or all components of the head and neck exercise apparatus 2810 may be considered a modification.
A head and neck exercise system may include at least one head and neck exercise apparatus with an airflow resistance mechanism that is adjustable or at least two head and neck exercise apparatuses with airflow resistance mechanisms that may be adjustable or not adjustable. The head and neck exercise system could be designed to provide a range of airflow resistances for the performance of head and neck exercises.
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The airflow indicator 3058 may be configured to respond with visual, auditory, or other feedback to airflow above a threshold rate, duration, or volume. One possible configuration would involve the motor 3062 serving as a generator to deliver electrical power to the airflow indicator 3058, but other configurations are possible. The rotating element 3060 may be configured to be adjustable and/or to respond to airflow in either direction. In this embodiment, the rotating element 3060 moves in a freely rotating fashion, but other movements (translation, limitation on rotation, etc.) are possible. The head and neck exercise apparatus 3014 may be configured to permit substitution of the rotating element 3060, motor 3062, resistance selector 3056, and/or airflow indicator 3058. The member 3014, rotating element 3060, motor 3062, resistance selector 3056, and/or airflow indicator 3058 may be configured to incorporate a valve mechanism that may alter resistance to airflow. A configuration to permit adjustment or substitution of at least one component may therefore result in a modifiable airflow resistance.
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In this embodiment, the head and neck exercise apparatus 3310 includes hinge pins 3378 that enable relative movement of the front housing piece 3376 and back housing piece 3377 as the outer pieces 3375 move back and forth. In this embodiment, the space between the front housing piece 3376 and back housing piece 3377 opens to permit substitution of the moveable element 3379, and movement of the outer pieces 3375 may close the space to secure the moveable element 3379 in place. The moveable element 3379 may be secured in position by the cooperation between the moveable element 3379, front housing piece 3376, and back housing piece 3377. In this embodiment, the periphery of the moveable element 3379 is thicker than the central portion to facilitate this cooperation, but other configurations (periphery of similar or lesser thickness, differences in shape, etc.) or mechanisms for cooperation (e.g., elements extending through the moveable element, etc.) are possible. The head and neck exercise apparatus 3310 may be configured with a mechanism to maintain the outer pieces 3375 in at least one position, for example, in a position with a closed space. The substitution of a moveable element 3379 with another moveable element 3379 may be considered a different head and neck exercise apparatus.
In this embodiment, the moveable element 3379 is composed of an oval-shaped flexible material (e.g., a membrane), but the moveable element 3379 may take other forms, including a flexible material of different shapes or sizes or any other configuration that permits movement (e.g., flexible material with some relatively rigid segments, lever arm, moveable component, etc.).
The resistance to displacement of the moveable element 3379 may be determined by properties of the moveable element 3379 (e.g., stiffness, thickness, size, etc.) or other components of the head and neck exercise apparatus 3310. The head and neck exercise apparatus 3310 may also include a mechanism (e.g., spring, lever, etc.) to adjust the resistance of a single moveable element 3379. A substitution or adjustment of any component of the head and neck exercise apparatus 3310 may be considered a modification, and any such modification may modify the resistance to displacement of the moveable element 3379.
The contact element 3380 may be manufactured in continuity with the front moveable element holder piece 3376, or they may be separable. The moveable element 3379 may be manufactured in continuity with the front housing piece 3376 and/or back housing piece 3377. In other embodiments, the outer pieces 3375 may have a different configuration that enables the user to position the head and neck exercise apparatus 3310 against a portion of the user's head and neck such that it remains in proper position without active assistance from the user.
The outer pieces 3375, front housing piece 3376, back housing piece 3377, hinge pins 2078, and contact element 3380 may be considered a housing, within which there may be additional components of the head and neck exercise apparatus 3310 or at least one component of at least one other head and neck exercise apparatus.
In this embodiment, the user may protrude their tongue in the performance of the head and neck exercise. In other embodiments, the head and neck exercise may involve other tongue movements (retrusion, lateral movements, etc.); such an exercise may require the modification or addition of components (e.g., clamps, moveable elements, etc.) to the head and neck exercise apparatus 2010.
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In another embodiment, it may be possible to perform head and neck exercises with the moveable element 3479 but with fewer components of the head and neck exercise apparatus, including no other components.
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The resistance to displacement of the moveable element 3579 may be determined by properties of the moveable element 3579 (e.g., stiffness, thickness, size, etc.) or other components of the head and neck exercise apparatus. The resistance to displacement of the moveable element 3579 may also be determined by any stretching of the moveable element 3579, for example by increasing the distance between the moveable element holders 3583. An adjustment or substitution of any component of the head and neck exercise apparatus may be considered a modification. In this embodiment, the stabilizing mechanism 3584 is straight, but in other embodiments it could incorporate at least one hinged and/or moveable component. In this embodiment, the outer pieces 3575 are in continuity with the moveable element holders 3583, but they may be separable in other embodiments.
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The framed moveable element 3869 may have certain advantages, including simpler positioning of a moveable component and improving performance of the head and neck exercise apparatus. There may also be disadvantages, including increased cost.
In this embodiment the outer pieces 3875 and frame dock 3871 are manufactured in continuity, but in other embodiments they may be separable.
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Head and neck exercises for sleep disordered breathing may include isotonic and/or isometric exercises that can involve muscles within and surrounding the oral cavity and/or pharynx. Methods have been proposed previously for head and neck exercises. These have generally not included the use of an apparatus or system. Some methods for head and neck exercises for sleep disordered breathing have included the use of apparatuses to brush or stroke the tongue or a single positive end-expiratory pressure valve with an adjustable threshold pressure, as described above.
Instead, printed, video, and/or audio materials may instruct the user in performance of a head and neck exercise for sleep disordered breathing using the apparatuses or system described elsewhere in this application. These materials may be pre-recorded or live and can be uniform or tailored to an individual or subgroup. After placement of the apparatus or system to the user's mouth, exercises may include the generation of positive or negative pressure within the head and neck apparatus or system. A user may be instructed to generate positive or negative pressure within the apparatus or system by activation of muscles of the oral cavity and/or pharynx. A user may also be instructed to generate positive or negative pressure within the apparatus or system by exhalation or inspiration. A user may also be instructed to protrude a portion of their head and neck against an apparatus or system by activation of muscles of the oral cavity or pharynx. The instructions may present the technique for performance of the exercise, including possible modifications. The method of instructing the user may include any aspect of exercise performance such as repetitions, duration of time, use of feedback information to indicate proper performance, or other parameters.
The method of instructing the user may match the features of any apparatus or system described elsewhere in this application. For example, a method may instruct a user to perform a head and neck exercise for sleep disordered breathing while positioning a head and neck exercise apparatus to the user's nose and creating a positive pressure within the proximal portion greater than a threshold pressure that is adjustable or not adjustable. The positive pressure may cause a valve mechanism operatively arranged with the member and biased towards a closed position to open when the positive pressure exceeds the threshold pressure such that the proximal portion is fluidly connected to a distal portion. The method of instructing the user may indicate the response that should occur with proper performance of the exercise. The threshold pressure may be based on at least one of a stiffness of the valve mechanism, a dimension of the valve mechanism, a dimension of the valve plate, or a dimension of the member.
In another embodiment, a method may instruct a user to perform a head and neck exercise for sleep disordered breathing while positioning a head and neck exercise apparatus to the user's nose and creating a negative pressure within the proximal portion greater than a threshold pressure that is adjustable or not adjustable. The negative pressure may cause a valve mechanism operatively arranged with the member and biased towards a closed position to open when the negative pressure is greater than the threshold pressure such that the proximal portion is fluidly connected to a distal portion. The method of instructing the user may indicate the response that should occur with proper performance of the exercise. The threshold pressure may be based on at least one of a stiffness of the valve mechanism, a dimension of the valve mechanism, a dimension of the valve plate, or a dimension of the member.
In another embodiment, a method may instruct a user to perform a head and neck exercise for sleep disordered breathing while positioning a head and neck exercise apparatus to the user's nose and creating a positive pressure within the proximal portion greater than a threshold pressure. The positive pressure may cause a valve mechanism operatively arranged with the member and biased towards an open position to close when the positive pressure exceeds the threshold pressure such that this blocks the fluid connection between the proximal portion and a distal portion that exists when the valve mechanism is in the open position. The threshold pressure may be adjustable or not adjustable. The apparatus may include at least one of an acoustic device, membrane, chromogenic material, or moveable element, each operatively arranged with the member and configured to respond to a pressure in the proximal portion being greater in magnitude than the threshold pressure.
In another embodiment, a method may instruct a user to perform a head and neck exercise for sleep disordered breathing while positioning a head and neck exercise apparatus to the user's nose and creating a negative pressure within the proximal portion greater than a threshold pressure. The negative pressure may cause a valve mechanism operatively arranged with the member and biased towards an open position to close when the negative pressure is greater than the threshold negative pressure such that this blocks the fluid connection between the proximal portion and a distal portion that exists when the valve mechanism is in the open position. The threshold pressure may be adjustable or not adjustable.
In another embodiment, a method may instruct a user to perform a head and neck exercise for sleep disordered breathing while positioning a head and neck exercise apparatus to the user's nose and creating a positive pressure within the proximal portion to produce an airflow or airflow rate against an airflow resistance determined by an airflow resistance mechanism that may be operatively arranged with a member. The apparatus may include at least one airflow resistance mechanism. The apparatus may or may not include an adjustment mechanism configured to alter the airflow resistance mechanism. The method of instructing the user may indicate the response that should occur with proper performance of the exercise, including production of a sufficient airflow or airflow rate. The apparatus may include at least one of an acoustic device, membrane, chromogenic material, visual signal, or moveable element, each operatively arranged with the member and configured to respond to an airflow or airflow rate greater in magnitude than a threshold airflow or threshold airflow rate, respectively. The airflow rate through the member may be based on at least one of a dimension of the member or a characteristic of the airflow resistance mechanism. A breathing exercise system may comprise a combination of head and neck exercise apparatuses.
In another embodiment, a method may instruct a user to perform head and neck exercises for sleep disordered breathing while positioning a head and neck exercise apparatus to the user and moving the tongue to displace a portion of a moveable element of the apparatus such that the portion of the moveable element is in contact with a component of the apparatus.
One characteristic of the apparatuses and systems described in this application is the threshold pressure or airflow resistance. A user may be instructed to perform Exercise 41 using Apparatus 41A having a first threshold pressure or airflow resistance at block 4151. Once the user is able to perform the exercise and meet certain criteria at block 4153 (e.g., number of repetitions, duration, or other means of determining a level of function), the user may be instructed to perform Exercise 41 with Apparatus 41B at block 4155, distinguished from Apparatus 41A by having a different threshold pressure or airflow resistance. Apparatus 41B may be a different physical device or have a different configuration from Apparatus 41A (e.g., with and without valve mechanism, different valve mechanism with different properties, different airflow resistance mechanism with different properties, etc.). Once the user meets certain criteria in the performance of Exercise 41 using Apparatus 41B at block 4157, the user may be instructed to perform Exercise 41 with Apparatus 41C at block 4159, with or without progression to other apparatuses. All permutations described elsewhere in this application are possible. Apparatus 41A (and any apparatus mentioned below) may correspond to any of the apparatus or head and neck exercise system configurations presented elsewhere in this application.
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The user may be instructed to perform multiple head and neck exercises for sleep disordered breathing with the use of the same apparatus or different apparatuses. The user may also be instructed to perform head and neck exercises for sleep disordered breathing without the use of any apparatus or system.
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While embodiments of the invention have been illustrated and described, it is not intended that these embodiments illustrate and describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Moreover, certain embodiments may be used in head and neck exercises for other conditions or user concerns involving muscles and/or other tissues of the head and neck. Other conditions or user concerns can include disorders of speech or swallowing, skin wrinkles, fat in the head and neck, teeth grinding, facial pain, and mouth breathing.