METHOD AND DEVICE FOR NASAL DILATION BY APPLYING FORCE TO A TARGET CHEEK AREA WITHOUT MANDIBULAR DISPLACEMENT
20170281394 ยท 2017-10-05
Inventors
Cpc classification
A61M16/0605
HUMAN NECESSITIES
A61F5/08
HUMAN NECESSITIES
International classification
Abstract
A nasal dilation device and method of use for depressing targeted areas of cheek tissue providing for enhanced inhalation and exhalation via dilation of nasal passageways away from the targeted areas. 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 pads adapted to engage target areas of a user's cheek and to maintain cheek tissue against a bone surface during inhalation and exhalation. The device includes a support element coupled to the pads to maintain the pads at the targeted areas during use.
Claims
1. A nasal dilation device, comprising: a pad engaging a target area of the user's cheek and maintaining cheek tissue at the target area against an underlying tooth structure during inhalation and exhalation, the target area being located between above a mandible and below a zygomatic bone of a given human head, and with the pad engaging the target area with a pad force of between 0.5 pounds to 3 pounds to maintain cheek tissue at the target area against the underlying tooth structure, and with substantially no external force being applied to the zygomatic bone or mandible of the user; and a support adapted to be head worn and providing the pad force at the target area, said pad force being applied by a pair of arms positioned rearward of the pads, with said mandible being maintained in its normal resting position while nasal passageways away from the target area are dilated.
2. The device of claim 1 wherein the head support structure includes is a spring.
3. The device of claim 2 wherein the spring is a yoke structure.
4. The device of claim 1 wherein said pad includes at least two portions having at least two substantially different levels of compressibility.
5. The device of claim 1 further comprising an adhesive for securing the pad in the target area.
6. The device of claim 5 wherein the adhesive is provided by an adhesive tape.
7. The device of claim 1 wherein the pad is a semi-spherical body.
8. The device of claim 1 wherein the pad force is between about 0.5 pounds to 1.0 pounds to the target area.
9. The device of claim 1 wherein the pad is gas-filled.
10. A nasal dilation device comprising: a pair of pads adapted to be placed against a user's cheeks, with each of said pair of pads being placed at a target area above a jawbone and below a zygomatic bone of the user; and a head-worn device including a spring structure depressing the pair of pads against said user's cheek tissue, said spring structure providing a cheek tissue-depressing force to said pair of pads resulting in an application of an external force to said user's cheek tissue at the target area and away from both the mandible and the zygomatic bone of the user, said force tending to limit movement of said user's cheek tissue during respiration and maintain inner cheek tissue against the user's gums and teeth during use, and with substantially no external forces being directly applied by the spring structure to either the zygomatic bone or mandible of the user and with substantially no jaw thrusting pressure being applied to the mandible, with said mandible being maintained in its normal resting position while dilating nasal passageways away from the target area.
11. The device of claim 10 wherein said pad includes at least two portions having at least two substantially different levels of compressibility.
12. The device of claim 10 further comprising an adhesive for securing the pad in the target area.
13. The device of claim 10 wherein the pad force is between about 0.5 pounds to 1.0 pounds to the target area.
14. The device of claim 10 wherein the pad is gas-filled.
15. A method using a nasal dilation device of claim 1 comprising: providing the pad against a user's cheek tissue at a target area between a jawbone and a zygomatic bone of the user; securing said pad against the user's cheek tissue with the support, said support applying the force through the pad to the user's cheek only at the target area and away from both the jawbone and zygomatic bone of the user; and dilating nasal passageways away from the target area by restraining movement of the user's cheek tissue by application of said force to said pad.
16. A method of a nasal dilation device of claim 10 comprising: providing the pair of pads in contact with the target area of the user's cheek tissue located above a jawbone and below a zygomatic bone of the user; securing the pair of pads in place with the spring structure, with said spring structure providing a force through said pad to maintain contact between the user's inner cheek and teeth and gums only at the targeted area and with substantially no external forces being applied by the spring structure to either the mandible or zygomatic bone of the user; and dilating nasal passageway by restraining movement of the user's cheek tissue by application of said force at the target area while maintaining the user's mandible in its normal resting position.
17. A method of nasal dilation using a head-worn dilation device, comprising: engaging a pair of target area of the user's cheek with a pair of pads; supporting the pair of pads at the target areas with a head worn support including a pair of arms positioned rearward of the pair of pads; and maintaining cheek tissue at the target areas against underlying tooth structure during inhalation and exhalation, the target area being located above a mandible and below a zygomatic bone of a given human head, with the pair of pads engaging the target areas with a pad force of between 0.5 pounds to 3 pounds to maintain cheek tissue at the target areas against the underlying tooth structure, and with substantially no external force being applied to the zygomatic bone or mandible of the user, and with a user's mandible being maintained in its normal resting position while nasal passageways away from the target areas are dilated by the pair of pads.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0033]
[0034] Referring to
[0035] As shown in
[0036] As shown in
[0037] 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
[0038] Nasal dilation assembly 100 is arranged and positioned on the head of a user as shown in
[0039] 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. Nasal dilation 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 nasal dilation 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.
[0040] Nasal dilation 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 nasal dilation device 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
[0041]
[0042] 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 nasal dilation assembly 100. If the nasal dilation 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 nasal dilation 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.
[0043] 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 nasal dilation assembly 100 allowing easy adjustment by the user. It was determined by the inventor during experimentation that nasal dilation 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.
[0044] 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 nasal dilation 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.
[0045] Nasal dilation assembly 100 is designed as a freestanding unit which can be used alone or with many mask assemblies for PAP usage. Nasal dilation 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
[0046] When nasal dilation 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 nasal dilation assembly 100 in proper position, breathing and respiration can be enhanced. The suitable and effective depression of the target area of the user's cheek enhances respiration in a significant number of individuals perhaps by neurological or neuromuscular stimulation means.
[0047] 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. Nasal dilation 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.
[0048] 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 nasal dilation assembly can enhance breathing and respiration, and when the nasal dilation 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'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.
[0049] 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.
[0050] 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 nasal dilation device 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 nasal dilation embodiment which depresses the approximate center of the cheek and also focuses specific pressure on the target area.
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[0053] 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.
[0054] 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.
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[0057] 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.
[0058] Football helmet assembly 50 of
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[0060] 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.
[0061] 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.
[0062] 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 force for pad 72 against the target area of the user's cheek, a stronger spring leg 76 can be used to provide more spring force inward.
[0063] 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.
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[0065] Ear protector cavity 86 is provided with a spring 90 to which pad 89 is provided to its inward facing side toward the user'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.
[0066] As shown in
[0067] As shown in
[0068] 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.