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1. Field of the Invention
The present invention relates generally to health and medical devices, and more particularly to an improved method and apparatus for the treatment of snoring and sleep apnea.
2. Discussion of Related Art including information disclosed under 37 CFR 61.97, 1.98
The fundamental cause of snoring is a restriction or blockage of the air passage in the throat. This occurs when muscles relax during sleep allowing soft tissue in the back of the throat to sag. This soft tissue then blocks the flow of air needed for breathing. Most people that snore overcome this blockage by breathing harder, and the increased air pressure partially opens up the air passage. The snoring sound is the restricted airflow vibrating the soft tissue. Besides the obvious noise, the snoring person also has laborious breathing that decreases the quality of sleep. In extreme cases of air passage blockage, there is a medical condition called obstructive sleep apnea where the quality of sleep is severely degraded.
There are hundreds of patents relating to anti-snoring devices. Almost all the mechanical devices that have been developed simply do not treat the fundamental cause of snoring because they do not open up the blocked air passage in the throat. There are two classes of mechanical anti-snoring devices that actually open up this blocked air passage. The first class opens the blocked air passage in the throat by forcing the lower jaw to jut forward to an unnatural position. However, these devices that force the lower jaw forward are very uncomfortable and can cause alignment problems with the teeth.
The second class of anti-snoring devices that opens the blocked air passage in the throat utilizes an air mask, a hose and a low-pressure air compressor to inflate the lungs and air passages to a pressure typically between 70 and 120 Pascal above atmospheric pressure (a pressure between about 7 mm and 12 mm of water). This class of device is usually called a CPAP machine (Continuous Positive Airways Pressure machine). These machines are expensive, uncomfortable and restrictive. About half of the people that start using CPAP machines to treat sleep apnea cannot tolerate them and discontinue their use.
All the known prior art anti-snoring devices that utilize an adhesive are intended to be worn somewhere on the face. These devices open the nose, distort the cheek or cover the mouth. None of these prior art adhesive devices stop snoring by expanding a portion of the neck to open up the blocked air passage in the throat.
For example, the following patents utilize an adhesive device to cover the mouth: French Patent No. 78 08083 to Blander; German Patent No. DE 3837277 to Obermeler; and U.S. Pat. No. 4,817,636 to Woods.
The following patents utilize an adhesive or suction device on the nose: U.S. Pat. No. 1,292,083 to Sawyer; U.S. Pat. No. 6,631,714 to Von Duyke; U.S. Pat. No. Re. 35,408 to Petruson; and U.S. Pat. No. 3,594,813 to Sanderson.
The following patents utilize an adhesive device on the cheek: U.S. Pat. No. 3,782,372 to Carlton; and U.S. Pat. No. 5,752,524 to Corcoran.
All the known prior art anti-snoring devices that utilize an implant utilize an implant in the soft palate to alter the dynamic response and reduce snoring. No prior art anti-snoring patents use an implant to expand an external part of the neck. Typical soft palate implant patents are: U.S. Pat. Nos. 6,848,447 6,634,362 6,601,585 6,578,580 6,523,543 to Conrad and U.S. Pat. Nos. 6,626,181 6,601,584 6,523,542 to Knudson.
U.S. Pat. No. 5,592,938 to Scarberry describes a body part enclosure comprising a sheath or rap that can be made rigid by the application of a vacuum. One of the applications briefly mentioned for this device is a sheath to create a partial vacuum on the neck as a treatment for sleep apnea. The vacuum is intended to draw out tissue and expand the airway during sleep to relieve airway obstruction. No specific design is given for a device that would treat sleep apnea.
The Scarberry prior art requires that the vacuum device be attached to a vacuum pump to compensate for minor leaks. Also, movement of a sleeping person can break the vacuum seal and cause a major leak. There will also be a strong pushing force exerted on the seals and this will tend to nullify any possible beneficial effect obtained from the vacuum expansion of other tissue. The invention herein is much more practical. The invention avoids the problems associated with vacuum by using mechanical means to connect to the skin.
The foregoing patents reflect the current state of the art of which the present inventor is aware. Reference to, and discussion of, these patents is intended to aid in discharging Applicant's acknowledged duty of candor in disclosing information that may be relevant to the examination of claims to the present invention. However, it is respectfully submitted that none of the above-indicated patents disclose, teach, suggest, show, or otherwise render obvious, either singly or when considered in combination, the invention described and claimed herein.
The method and apparatus for treatment of snoring and sleep apnea of this invention provides adhesive patches to exert a predetermined force on two areas of the neck, causing these areas of the neck to expand outward from their normal position. This expansion opens a blockage in the throat of a sleeping person, thereby eliminating snoring and helping some people with obstructive sleep apnea. The force required to expand these two areas of the neck is balanced by pressing on another area of the neck, located generally between the two expanded areas.
The present invention describes how humans have multiple responsive points within a specific area of the neck (hereafter called the “throat stimulation area”) that exhibit the ability to stimulate the throat in such a way as to open the blockage in the air passage of a sleeping person. This eliminates snoring and sleep apnea in some people. To achieve this result, the surface of the skin in at least a portion of the throat stimulation area must be pulled so that the surface of the skin is extended by at least 2.5 mm beyond the normal position. The invention provides an attachment device, such as an adhesive coated patch, that attaches to the skin over at least one responsive point. Pulling on this patch expands the skin and maintains an open-air passage in a sleeping person. The snoring sound is reduced or eliminated and even some people with obstructive sleep apnea can have their breathing passage opened by this invention.
In the preferred embodiment (
It is another object of the present invention to provide a new and improved anti-snoring device.
A further object or feature of the present invention is a new and improved anti-snoring device, which is comfortable in use.
An even further object of the present invention is to provide a novel anti-snoring device that expands a portion of the user's neck to facilitate breathing.
The foregoing summary broadly sets out the more important features of the present invention so that the detailed description that follows may be better understood, and so that the present contributions to the art may be better appreciated. There are additional features of the invention that will be described in the detailed description of the preferred embodiments of the invention which will form the subject matter of the claims appended hereto.
Accordingly, before explaining the preferred embodiment of the disclosure in detail, it is to be understood that the disclosure is not limited in its application to the details of the construction and the arrangements set forth in the following description or illustrated in the drawings. The inventive apparatus described herein is capable of other embodiments and of being practiced and carried out in various ways.
Also, it is to be understood that the terminology and phraseology employed herein are for descriptive purposes only, and not limitation. Where specific dimensional and material specifications have been included or omitted from the specification or the claims, or both, it is to be understood that the same are not to be incorporated into the appended claims.
As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based may readily be used as a basis for designing other structures, methods, and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims are regarded as including such equivalent constructions as far as they do not depart from the spirit and scope of the present invention. Rather, the fundamental aspects of the invention, along with the various features and structures that characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the present invention, its advantages and the specific objects attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there are illustrated the preferred embodiment.
The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein:
The instant application is a continuation-in-part of U.S. Utility patent application Ser. No. 11/102,314, filed Apr. 8, 2005, which is a continuation-in-part of U.S. Utility patent application Ser. No. 10/866,058, filed Jun. 10, 2004 (Jun. 10, 2004), each of which application is incorporated in its entirety by reference herein.
Referring now to
Responsive point 27F is also proximate the left edge of the trachea. On the test subject, responsive point 27F is about 4 cm below the carotid artery pulse point 27E. Responsive point 27E is the lowest of the responsive points and may be termed the “lower neck responsive point.” Finally, and as noted previously, responsive point 27G is located on the anterior cervical midline, or roughly the center of the trachea. Not all the responsive points work the same way and these differences will be discussed in detail below. Responsive points 27E (left and right) are believed to be the most important of the eleven responsive points. Responsive point 27F (left and right side) are also important, but should be used in conjunction with responsive points 27E. The preferred embodiment (
Throat stimulation area 22 in
An experiment was performed using a flat piece of plastic 21 square centimeters in area. The plastic was adhered to a subject's neck using double coated tape and covered responsive points 27A, 27B, 27C and 27E. The subject then relaxed muscles in his jaw and neck. This caused the subject's breathing passage to close because the subject suffers from sleep apnea and relaxing the neck muscles simulated the sleeping condition. Very laborious breathing could partly open the breathing passage and caused a snoring sound. It was found that pulling on the plastic immediately opened the blocked air passage. In fact, it was nearly impossible to make a snoring sound as long as there was a pulling force on the plastic and as long as the jaw was positioned with the lower teeth slightly separated from the upper teeth.
The amount of force required to stop the simulated snoring depended on whether the head was tilted forward or back and also depended on the degree of opening between the lower and upper jaw. The simulated snoring sound stopped for a specific head position when the pulling force reached 0.25 Newton (about 25 gram force). This is equivalent to lowering the external pressure on the area covered by the patch by about 120 Pascal (about 12 mm of water). This 120 Pascal pressure reduction is the exact opposite of the 120 Pascal pressure increase sometimes used by continuous positive air pressure (CPAP) machines to open a blocked air passage. This pressure similarity might not be a coincidence since the internal pressure exerted by continuous positive air pressure machines also expands the portion of the neck covered by the patch. It is possible that some of the benefit of CPAP machines is the result of expanding this area. In any case, it appears that in some people, exerting a pulling force on the skin of the neck in the above-described throat stimulation area has a similar beneficial effect to raising the internal pressure on the entire respiratory system.
Not all snoring and sleep apnea sufferers have the same cause of throat blockage. For example, the shape of tonsils, the tongue and the soft pallet differ. There may be additional responsive points within the throat stimulation area that can be found experimentally by those having skill in the art. Therefore, the teaching here is that there are multiple responsive points within the throat stimulation area that can reduce snoring when the skin over one or more responsive point is pulled to expand (lift) the skin surface by at least 2.5 mm beyond its rest position when the tissues in the region are in a generally relaxed state.
The solution to the above-described coupling problem is described in U.S. Pat. No. 6,919,787, to Macken, the inventor herein, and titled “Method and Apparatus for Magnetic Coupling,” which patent is incorporated in its entirety by reference herein. Briefly,
It is not necessary to use this coupling means to attach patches 30J and 30JJ to the bow coupler 37J. In fact, any elastic means in compression, such as a spring, can be used to supply the required force to exert a force urging patches 30J and 30JJ away from one another.
In one test, the size of bow connector, 37F, was adjusted so that it exerted a 0.33 Newton pulling force (about 34 gram force) on patches 30J and 30JJ. This force was sufficient to open the blocked air passage for a person who suffers from obstructive sleep apnea. Less force may be required for a person with only a snoring problem.
Other shapes and materials (such as plastic or rubber) can be used for the support member 31 of the adhesive. The reason for the use of steel in this embodiment is to make easy attachment and removal using magnets. Also the use of tape simplifies construction, but it is desirable to cover the adhesive 34J with a release liner prior to usage. A peel-off release liner can be provided and is desirable for storage of a adhesive anti-snoring device prior to use. Therefore,
In experiments, 31J and 34J together were a piece of tape, 25 mm×25 mm×0.8 mm thick. Ferromagnetic material 31K was a 0.75 mm thick steel washer, 16 mm outer diameter and 5.6 mm inner diameter. This steel washer was attached to tape 31J. The spherical magnet 41J was 6.35 mm (¼ inch) in diameter and made from the rare earth magnetic material known as NdFeB. The patches 30J and 30JJ were attached to the test subject as shown in
If the test subject normally sleeps with his jaw completely closed (teeth contacting), and if the blockage is strong, then it is advisable for the subject to also wear a commercially available dental spacer to slightly separate the teeth. This is a plastic device that fits over the front two teeth and is usually used to prevent grinding of the teeth. This device is completely different from oral anti-snoring devices that cause the jaw to jut forward unnaturally. Those oral anti-snoring devices are uncomfortable, and can shift the position of teeth.
The preferred embodiment is depicted in
Many of the components used in
The key difference between the preferred embodiment shown in FIGS. 6 to 8 and the embodiments shown in the parent application and the progeny cited as a priority documents herein, is that the preferred embodiment herein exerts “pushing force” pressure on the preferred pressure area 28 in
The soft pad 36P makes contact with the skin over preferred pressure area 28. Soft pad 36P exerts sufficient pressure on preferred pressure area 28 to counteract the pulling force exerted on pads 30J and 30JJ.
The coupler 37P transfers the force between pad 36P and patches designated with tape 31J and 31K. In
There are infinite variations of possible designs that accomplish the goal of pulling on the skin over the carotid artery pulse point 27E and pushing on the preferred pressure area 28. It is not necessary to utilize the second responsive point over 27F. Expanding the skin over responsive area 27E is by far the most important objective. Therefore, much of the beneficial effects of anti snoring and anti sleep apnea would be achieved without also pulling on the skin over 27F. For example, the coupler 37P or 37Q could be extended and attach to the skin over the collar bone and still obtain most (but not all) the anti snoring and anti sleep apnea benefits.
Therefore, the key elements of the invention are that an elongated anti snoring device has adhesive areas at each end of the device and a central region of the anti-snoring device is designed to exert pressure. The shape and material of the anti-snoring device is such that in use an adhesive pulls on a portion of the neck designated the carotid artery pulse point (27E) and a portion of the anti snoring device presses on a portion of the neck designated the preferred pressure area 28, such that a blocked air passage in a sleeping human is opened, thereby reducing snoring and possibly helping sleep apnea. The preferred usage has the second adhesive surface attached to a portion of the neck designated the “lower responsive point” 27F.
The above disclosure is sufficient to enable one of ordinary skill in the art to practice the invention, and provides the best mode of practicing the invention presently contemplated by the inventor. While there is provided herein a full and complete disclosure of the preferred embodiments of this invention, it is not desired to limit the invention to the exact construction, dimensional relationships, and operation shown and described. Various modifications, alternative constructions, changes and equivalents will readily occur to those skilled in the art and may be employed, as suitable, without departing from the true spirit and scope of the invention. Such changes might involve alternative materials, components, structural arrangements, sizes, shapes, forms, functions, operational features or the like.
Therefore, the above description and illustrations should not be construed as limiting the scope of the invention, which is defined by the appended claims.
The present application is a continuation-in-part of U.S. Utility patent application Ser. No. 11/102,314, filed Apr. 4, 2005 (Apr. 8, 2005), which is a continuation-in-part of U.S. Utility patent application Ser. No. 10/866,058, filed Jun. 10, 2004 (Jun. 10, 2004).
Number | Date | Country | |
---|---|---|---|
Parent | 11102314 | Apr 2005 | US |
Child | 11761337 | Jun 2007 | US |
Parent | 10866058 | Jun 2004 | US |
Child | 11761337 | Jun 2007 | US |