Device for preventing snoring and obstructive sleep apnea

Abstract

An oral appliance (OA) is made as an additional optional feature in a user's denture with or without an implant to facilitate adjustable mandibular advancement to help partially or completely reduce snoring and thereby improve obstructive sleep apnea (OSA). The mandibular advancement is accomplished by employing pins in the denture set and employing a set of strips that may have optional features such as grooves, reinforcements, and the OA may be made of biocompatible materials, using several manufacturing methods including 3D printing, molding, or milling. Alternatively, an optional additional method includes the economical production of similar or alternatively simpler and lighter secondary units that can be provided at discounted prices to a patient who subscribes a primary denture, which function as a cosmetic function as well as an anti-snoring function.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Serial No. 17 / 824,897, filed on May 26, 2022, the entire contents of which are hereby incorporated by reference. Technical Field

[0003] The present invention relates to an oral appliance for preventing snoring, sleep apnea or similar other conditions, and more particularly to an oral appliance that can be used by a person wearing dentures, a method of making the same, and use thereof. Background Art

[0004] It is well known and documented that people with sleep-related breathing disorders, such as sleep apnea, exhibit moderate to severe snoring, which is often ignored or neglected without any preventive or treatment measures. It is also known that this neglect is creating an increased risk for more serious health problems later in life, such as stroke, atrial fibrillation, hypertension, chronic heart failure, excessive daytime sleepiness leading to driving accidents or equipment operating accidents, and various medical conditions, such as diabetes, depression, and the fact that episodes of obstructive sleep apnea (OSA) can be life-threatening; however, 80% of moderate and severe cases of obstructive sleep apnea may go undiagnosed (Source: American Sleep Apnea Association: Sleep Apnea Information for Clinicians - A Concise Lesson on Sleep Apnea; Hu, Publication No. US2020 / 0129278, dated April 30, 2020). For example, studies have shown that people who exhibit snoring are likely to have OSA, which may contribute to one or more of the above health problems. OSA is characterized by periodic, repetitive collapse of the upper airway during sleep, the frequency of which is expressed as the apnea and hypopnea index (AHI), which represents the average number of apneas and hypopneas per hour of sleep. Healthcare professionals use the terms respiratory disturbance index (RDI) and AHI interchangeably. Apnea episodes typically result in complete cessation or pauses in breathing for 20 to 40 seconds, while hypopnea episodes typically result in shallow or partial breathing with a 30% or greater decrease in airflow lasting 10 seconds or more, with a greater than 4% desaturation of the patient's oxygen level, often resulting in fragmentation of sleep or arousals. The AHI is calculated by dividing the sum of apneas and hypopneas by the number of hours of sleep. AHI values ​​are categorized as follows: severe if there are more than 30 episodes per hour, moderate if there are between 15 and 30 episodes per hour, and mild if there are 5 to 15 episodes per hour. These episodes of reduced airflow are usually caused by varying degrees of relaxation of the tongue and pharyngeal walls during several stages of sleep, in which the muscle tissue supporting these tissues relaxes, so that when air is inhaled, the tongue and posterior pharyngeal wall collapse, resulting in snoring, which is actually a vibrating noise caused by partial or complete obstruction of the airway. Episodes can lead to several undesirable conditions, such as decreased oxygen levels in the blood (hypoxemia), increased circulating carbon dioxide (hypercapnia), and arousal from sleep to reestablish a stable airway.

[0005] A rigorous research report published in The Lancet in 2019 (Markets and Markets. Sleep Apnea Device Market, Report Code: MD 1181, Release Date: August 2021) found that nearly 1 billion adults aged 30 to 69 years worldwide may suffer from OSA, and the number of people with moderate to severe OSA who are generally recommended for treatment is estimated to be close to 425 million. Much of the actual market remains untapped or unserved because a large number of patients remain undiagnosed (Adam Benjafield, Najib T Ayas, Peter R Eastwood, Raphael Heinzer, Mary SM Ip, Mary J Morrell, Carlos M Nunez, Sanjay R Patel, Thomas Penzel, Jean-Louis D Pépin, Paul E Peppard, Sanjeev Sinha, Sergio Tufik, Kate Valentine, and Atul Malhotra. “Estimates of the global prevalence and burden of obstructive sleep apnea: a literature-based analysis,” Lancet Respiratory Medicine, August 2019; Vol. 7(No. 8): 687-698), because they are not even aware of the condition and risk, because symptoms only occur when the person is sleeping, and when limited close individuals (such as bed partners) may dare to point them out they are often not believed, pointing out these symptoms more because of annoyance caused by noise disturbances, such as snoring or in some cases accompanied by teeth grinding (called bruxism), and rarely out of real concern for the patient's health problems. The largest numbers of patients are in China, the United States, Brazil, and India (in descending order), with the United States estimated to have over 54.1 million people with an AHI of 5 or more events per hour and over 23.6 million with an AHI of 15 or more events per hour. Some estimates are even higher, for example, Ramabadran, in U.S. Patent No. 11,147,506, dated October 19, 2021, entitled "Sleep Diagnostic System and Method," reports that nearly 65 million U.S. adults have sleep disordered breathing conditions, with one in five adults suffering from obstructive sleep apnea or central sleep apnea conditions, and considering that of this large number of estimated patients, perhaps only one in fifteen adults are properly screened, tested, and treated, leaving a large number of people untested and uncared for. Canada has a large number of affected people: over 4.7 million people with an AHI of 5 or more events per hour and over 900,000 people with an AHI of 15 or more events per hour.The extent and nature of the problem has led to an ongoing discussion about whether changes need to be made to the way diagnosis and treatment are currently funded by public health and private insurance coverage (Sachin R. Pendharkar, Marcus Povitz, Nick Bansback, Charles F. P. George, Debra Morrison, Najib T. Ayas, working for the Canadian Sleep and Circadian Network, “Detection and treatment of obstructive sleep apnea in Canada: Funding models must change,” CMAJ, 11 December 2017, vol. 189: e-pp. E1524-8. doi: 10.1503 / cmaj.170393).

[0006] While severe sleep-related breathing disorders may require continuous positive airway pressure (CPAP) therapy, less severe sleep-related breathing disorders can be treated with other therapies or devices, such as oral appliances (OAs). Typically, oral appliances include one of two types: a single monolithic device that promotes the user's mandible (mandible) to advance forward relative to the user's upper jaw (maxilla); or alternatively a dual-block device in which the upper and lower dental braces are coupled together in such a way as to achieve similar mandibular advancement. Therefore, OAs are often referred to as mandibular advancement devices (MADs) or mandibular advancement splints (MASs). During sleep, the user's airway is cleared by the forward advancement of the mandible, which helps prevent the soft tissues of the tongue and throat from collapsing into the airway passage. In OA, it is important to achieve the correct amount of forward mandibular advancement. For example, the soft tissues of the user's tongue and throat may not be prevented from collapsing into the user's airway, so if the forward mandibular advancement promoted by the OA is insufficient, they may continue to suffer from sleep-related breathing disorders. Conversely, if the forward mandibular advancement promoted by the OA is too great, the user may experience undesirable discomfort in the jaw musculature, dental pain, or even more serious side effects such as temporomandibular joint (TMJ) pain (e.g., as reported in Marklund, M., Franklin, K.A., "Long-term effects of a jaw repositioning appliance on sleep apnea symptoms," Journal of Sleep Research, 2007, Vol. 16, pp. 414-420; and Pliska, B.T., Nam, H., Chen, H., Lowe, A.A., Almeida, F.R., "Obstructive sleep apnea with a mandibular advancement splint: occlusal effects and progression of changes associated with a decade of treatment," Journal of Clinical Sleep Medicine, 2014, Vol. 10, pp. 1285-1291). In extreme cases, discomfort may cause the user to stop wearing the OA altogether, and in many other cases, undesirable awakenings from sleep may be reported.

[0007] Some oral appliances have been disclosed that include a mechanism for adjusting the amount of mandibular advancement provided by the oral appliance. These are referred to as adjustable or titratable devices.

[0008] Halstrom, in U.S. Patent No. 5,365,945, dated November 22, 1994, entitled "Adjustable Dental Appliance for Treating Snoring and Obstructive Sleep Apnea," describes an appliance that includes: an upper bite block that conforms to the patient's maxillary dentition; a lower bite block that conforms to the patient's mandibular dentition; and a connecting assembly fixed to the front areas of the upper and lower bite blocks for adjustably or titrably connecting the upper and lower bite blocks together.

[0009] Lowe in WO1995019746 dated July 27, 1995 and entitled "Mandibular repositioning appliance for preventing snoring" describes a device formed by an upper bite block and a lower bite block, which are connected to each other by an expandable connector, which includes a rear section connected to the rear part of the upper bite block and a front section connected to the front part of the lower bite block, and an adjustable threaded element interconnecting the front and rear sections to affect the relative position.

[0010] Fenton, in U.S. Pat. No. 5,499,633, dated March 19, 1996, entitled "Anti-Snoring Device with Adjustable Upper and Lower Associated Members," describes an anti-snoring device that includes an upper member for receiving a user's upper teeth, the upper member being connected in spaced relation to a lower member for receiving the user's lower teeth. The lower member is selectively positioned relative to the upper member so that the lower member moves the user's lower jaw to a position forward of its "normal" resting or occlusal position by receiving the user's lower teeth. This forward movement of the lower jaw is alleged to significantly open the user's airway, thereby alleviating, reducing, or eliminating snoring.

[0011] Kidd and Lane, in U.S. Patent No. 5,829,441, dated November 3, 1998, entitled "Customizable Dental Device for Snoring and Sleep Apnea Treatment," describe a mandibular extension dental device comprising an adjustable upper arch, a lower arch, and a coupling device designed to pull the user's jaw forward during sleep to minimize snoring and mild apnea conditions. The device is intended to be quickly installed on site without the services of a dentist.

[0012] Another configuration of a nighttime, dentally retained intraoral appliance for treating snoring and obstructive sleep apnea is described in US Patent No. 5,868,138, dated February 9, 1999, to Halstrom, entitled "Dental Appliance for Treating Snoring and Obstructive Sleep Apnea."

[0013] Strong, in U.S. Patent No. 6,526,982, dated March 4, 2003, entitled "Anti-snoring device and method of making the same," describes an anti-snoring device having an upper jaw bite model and a lower jaw bite model and an outwardly extending pivot that is mounted to the bite model by a frame that is at least partially embedded in the bite model and is said to be able to securely hold the pivot in place even in the face of extensive molars.

[0014] Palmisano, in U.S. Pat. No. 6,536,439, dated March 25, 2003, entitled "Device and Method for Treating Conditions Including Obstructive Sleep Apnea and Snoring," describes a maxillary expansion device that is mounted to the teeth of the maxilla and the maxilla is expanded by the operation of a spiral orthodontic appliance, so that after the maxilla is stabilized, the minimum cross-sectional area of ​​the nasal cavity is increased, reducing nasal airway resistance, thereby curing or improving obstructive sleep apnea and / or snoring.

[0015] Palmisano, in U.S. Pat. No. 6,604,527, dated August 12, 2003, entitled "Mandibular Advancement Device," describes a device custom made for each user based on the desired model of the user's jaw, the device having a lower bite block with a pair of upwardly extending flanges and an upper bite block with a pair of downwardly extending flanges, each flange having an engagement surface. When the bite block is mounted on the user's jaw during sleep, the lower engagement surfaces and the upper engagement surfaces engage and cause the mandible to be advanced forward from an open reflex path, and such engagement and advancement are maintained while allowing movement to the normal range of jaw opening.

[0016] Palmisano and Mehta described a version of the above in EP 1094761 published on October 29, 2008. Bedford disclosed some updates and improvements over Palmisano in US 2018 / 0360646 dated December 20, 2018, entitled "Mandibular Advancement Device" and AU 2021250941 dated October 15, 2021, entitled "Mandibular Advancement Device". The introduction of a ratchet mechanism to effect advancement of the mandible, and the lower and upper portions being formed of relatively rigid lower and upper outer shells, relatively soft lower and upper liners, and thermoformed lower and upper liners therebetween, appear to be the newly claimed innovative steps.

[0017] Scarberry et al., in U.S. Patent No. 8,205,617, dated June 26, 2012, and entitled "Oral Appliance for Treating Snoring and Sleep Apnea," describe an oral appliance system that includes an upper dental tray and a plurality of lower dental trays. The upper dental tray is adapted to conform to the upper dentition of a user, and each lower dental tray is adapted to conform to the mandibular dentition of the user. The lower dental trays are configured to engage the upper dental trays, and each lower dental tray is configured to promote a different fixed amount of mandibular advancement and / or a different amount of vertical height.

[0018] Kopp, in U.S. Patent No. 8,640,705, dated February 4, 2014, and entitled “Anti-Snoring Device,” describes a device for mandibular advancement in which an elongated hole and a pair of protruding connectors referred to as an S-shaped design in combination with U-shaped upper and lower mandibular bars are said to provide resilience and therefore a spring action.

[0019] Fallon, Jung, and Fallon, in U.S. Patent No. 8,833,374, dated September 16, 2014, entitled "Intraoral Mandibular Advancement Appliance," describe a mandibular advancement device in which an upper and lower dental tray assembly are shaped to hold the upper and lower teeth of a user, respectively, and can be adjusted and locked in different positions relative to each other. A tongue support is also provided to prevent the tongue from falling and blocking the patient's airway.

[0020] Petelle and Fleury, in U.S. Patent No. 9,545,330, dated January 17, 2017, entitled "Intraoral Orthosis, Method of Making Such Orthosis, and Method of Adjusting Such Orthosis," describe an intraoral orthosis for treating snoring and sleep apnea syndrome, the intraoral orthosis comprising two shells connected together by an adjustable connection device, the adjustable connection device comprising two notched tabs respectively disposed on either side of one of the shells, each notched tab being adjustably engaged with a corresponding adjustment shell, the adjustment shells being correspondingly disposed on either side of the other shell, the adjustment shells being integrally formed with the other shell, each adjustment shell being connected to the other shell by a foldable support structure. This version was earlier described in U.S. Patent No. 9,095,454, dated August 4, 2015, with the same title.

[0021] Kim et al. described a construction in U.S. Patent No. 9,949,868, dated April 24, 2018, entitled “Mandibular Advancement Device,” in which the relative positions of upper and lower wings on upper and lower splints enable desired mandibular advancement, claiming to follow a digital design method based on obtaining electronic data about the shape of the user's dentition to manufacture a set of at least two devices as an invention.

[0022] Baratier and Palomino describe an intraoral device in U.S. Patent No. 10,363,160, dated July 30, 2019, entitled “Jaw Repositioning Device,” which includes an upper splint configured to engage with one or more teeth of a user's maxilla and a lower splint configured to engage with one or more teeth of a user's mandible, a pair of lateral connecting rods (each connecting rod having a first rod end connected to the lower splint and a second rod end connected to the upper splint), the connecting rods being configured to maintain the mandible in an anterior position relative to the maxilla.

[0023] Veis and Ataii, in U.S. Patent No. 10,363,161, dated July 30, 2019, and entitled “Oral Appliance for Sleep Apnea During Orthodontic Treatment,” describe a sleep apnea oral appliance in which a pair of appliance trays are worn on orthodontic trays that contact the maxillary dentition and the mandibular dentition, respectively, and can include a series of different configurations to change the position of the user's teeth and / or the shape of the user's jaw.

[0024] Fallon describes an oral appliance in U.S. Patent No. 10,849,783, dated December 1, 2020, and entitled "Fully-Mobility Jaw Advancement Oral Appliance for Reducing the Effects of Snoring and / or Sleep Apnea," which includes an upper arch support assembly for receiving the user's upper teeth, a lower arch support assembly for receiving the user's lower teeth, and an intermediate guide post support bracket, which is connected to the lower arch support assembly at its bottom and to the upper arch support assembly at its top via an upper arch support retaining post extending therebetween.

[0025] Mortadi describes an oral device in U.S. Patent 10,888,451, dated January 12, 2021, entitled "Oral Device and Method of Manufacturing for Preventing Sleep Apnea," which provides an upper plate and a lower plate, each plate being adapted to retain the occlusal surfaces of a corresponding set of maxillary teeth and mandibular teeth, wherein a pair of S-shaped curved bars pivotally interconnecting the two plates are used to maintain an operable spaced relationship therebetween.

[0026] Radmand describes in U.S. Patent 11,191,663, dated December 7, 2021, and entitled “Oral Appliance and Kit for Treating Sleep Apnea,” an oral appliance for treating obstructive sleep apnea that includes a mouthpiece embedded with various sensors and stimulators and is constructed to be received in the user's mouth.

[0027] Kopelman describes three different optional embodiments in U.S. Patent No. 11,207,208, dated December 28, 2021, entitled "System and Method for Positioning the Mandible of a Patient in Responsive to a Sleep Apnea State," in which a rotor element, or a linear propulsion structure, or winding and unwinding of a tether element and the use of an actuator are used to achieve relative advancement of the bottom portion relative to the upper portion.

[0028] However, these and other similar oral appliances are targeted at users with natural teeth, as the devices are intended to be worn over both the mandibular and maxillary dentition. Additionally, they are expensive, complex to manufacture, and have adjustment mechanisms that are difficult to operate. Furthermore, currently available OAs that include adjustment mechanisms tend to be bulky, which adversely affects user comfort, and further, these known OAs are difficult to properly fit, do not allow for adequate vertical or horizontal movement of the jaw when worn, and are not flexible enough to make them suitable for those who typically wear standard plain or implant-retained dentures (also referred to in the art as overdentures). Therefore, there is a need for a more targeted oral appliance for avoiding snoring and thereby providing a possible preventive measure or treatment for OSA that can provide a solution for this unaddressed user market segment while at least partially overcoming the above-mentioned limitations and other disadvantages associated with known oral appliances. Summary of the invention

[0029] Description of the Purpose of the Invention

[0030] Wearable oral device solutions for avoiding snoring and thus possible OSA OA, such as mandibular advancement devices (MADs), are often very similar to dentures and can be recommended by dentists or even denture technicians to avoid the logistical complexity of a Level 1 test required for an overnight stay in a lab for a physician-prescribed intervention. The broad market for sleep disorders includes interventions at different levels of complexity (Level 1, 2, 3, and 4 in descending order of complexity), followed by CPAP as the main choice for direct physician recommendation, and then turning to OA for patients who mainly cannot tolerate or do not like CPAP. A considerable number of users of CPAP machines report many problems with use, such as difficulty in obtaining the correct mask style and size, difficulty getting used to wearing the device during sleep, difficulty tolerating forced air, dry nose and / or mouth, feeling claustrophobic, mask leaks, skin irritation or pressure sores, difficulty falling asleep, and many such inhibitions. The inherent difficulties of CPAP machines result in high failure rates among patients who use them, which may be as high as 50% (Hu, Publication No. US2020 / 0129278, published April 30, 2020). Currently, CPAP is used as a first-line treatment for OSA only after the condition becomes severe, which seems to be the main reason for the large number of undiagnosed patients (Benjafield et al., Lancet, 2019).

[0031] The niche area we are initially addressing with this invention disclosure is to fulfill a relatively small but concentrated market service in the elderly (considered to be 60+ in some countries, but may vary by country, e.g., lower or higher, e.g., 65+ in some countries) and near-elderly (e.g., 50+ to 55+ up to geriatric age) markets who will need full or partial dentures regardless of underlying snoring or OSA. According to several estimates cited in the Journal of Prosthodontics, an estimated 37.9 million Americans will need dentures in 2020 (Douglass et al., "Will the United States Need Full Dentures in 2020?", Journal of Prosthodontics, January 2002, Vol. 87(No. 1): 5-8, doi: 10.1067 / mpr.2002.121203). This is almost 9% of the U.S. population. Since the Canadian population is approximately 0.11 of the U.S. population (Simon Fraser University, Comparative Populations of Canada, the United States, and Mexico: A Fact Sheet, World Population), assuming similar North American demographics, the estimated number of Canadian denture users is 4.17 million, bringing the total potential users of the disclosed invention to approximately 42 million. By providing features that are either integrally embedded or as an add-on optional accessory in these denture devices, enhancing the dentures to prevent and avoid snoring and thereby serve as an initial measure to avoid the onset or suffering of early OSA, we will provide a groundbreaking solution that is not currently available on the market.

[0032] Our strategy for addressing the needs of this niche but important market segment as contemplated by this invention disclosure is to provide a preventative and prophylactic anti-snoring option that addresses the annoyance of snoring noise generation and protects people from OSA, whether diagnosed or not. It may be noted that all currently available MADs on the market described in the previous section of this invention are worn over natural teeth, and thus the field is vast without any competing products that can be worn by this niche market segment.

[0033] Currently, the only option currently available for full denture wearers that comes closest to meeting the needs of this niche market is from an Australian-based company Edentulous TM , which is quite expensive. However, this product is not part of or can be worn over a denture; it is an additional product that requires the user to remove their regular denture and obtain and wear this expensive device separately. Another limitation is that for users who do not have upper teeth (in the maxilla), it can only be obtained from Flex or Classic or MAS offers an edentulous option, which implies that the presence of lower teeth (in the mandible) is required. Generally, it is recommended as a prerequisite that the user should have 6 lower teeth (3-3) in the mandible (according to the product brochure SomnoDent-Edentuluos-MAS-Brochure.pdf). Therefore, we can conclude from this brief description of the purpose of the invention that filling a very desirable gap in the field by providing a solution for a large number of patients suffering from snoring and obstructive sleep apnea will be the first introduction of such an option for people without a full or partial mouth of natural teeth.

[0034] Summary of the invention

[0035] Preferred embodiments of the disclosed invention provide additional optional features in the user's dentures to facilitate adjustable or titratable mandibular advancement, helping to partially or completely reduce snoring and thereby improve obstructive sleep apnea. The additional optional features in the denture set can be provided in ordinary dentures without implants, such as removable partial dentures (RPDs), removable complete dentures (RFDs); or can be provided in any of implant-supported dentures (ISDs), i.e., single-tooth implants, multiple teeth on implant-supported bridges, and multiple teeth on implant-retained dentures. Dentures are also called denture prostheses.

[0036] According to one aspect of the invention, the denture set may be provided with an optional set of pins or other means to maintain the mandibular portion of the denture in an anterior position relative to the maxillary portion of the denture using a set of straps of varying lengths. Additionally, or alternatively, the straps may have slots or grooves to allow relative movement between the mandibular and maxillary portions of the denture.

[0037] According to another aspect of the invention, alternatively, but additionally, the strips may be made of a lightweight, flexible biocompatible material, such as nylon-12 or a stretchable biocompatible elastomer, thereby allowing relative movement between the mandibular and maxillary portions of the denture in multiple directions in 3D space, i.e., forward and backward, upward and downward, left and right. The strips may be manufactured by several alternative methods, such as molding, 3D printing, blanking or stamping or other methods available in the most advanced technology.

[0038] According to another aspect of the invention, alternatively, but additionally, the strip may be made of a multi-layer hybrid structure, wherein the stronger material, e.g. ( Wilmington, Delaware, USA) line, which is the core that provides strength, and the biocompatible material (such as nylon-12) is coated on it, thereby allowing a combination of strength and flexibility in the relative movement between the mandibular and maxillary parts of the denture in multiple directions in 3D space, that is, forward and backward, upward and downward, left and right. The multi-layer structure can be achieved by several alternative manufacturing methods, such as molding, 3D printing, or other methods that can be available in the most advanced technology.

[0039] According to an additional but optional aspect of the present invention, a preliminary impression of the patient's mouth obtained by the dentist or denture technician by applying pressure to the soft tissues to simulate occlusal forces and extending the boundaries of the mold into the adjacent edentulous areas to better fit the denture to the gingiva, usually in wax in preparation for a diagnostic cast or a final cast made of plaster or other suitable material, can effectively serve the dual purpose of fabricating a denture set as well as a splint set for mandibular advancement.

[0040] In accordance with another additional but optional method of use of the present invention, the construction of the patient's dentures available to the dentist or denture technician can be effectively used for the additional purpose of making an optional lightweight splint set for mandibular advancement, providing a preventive measure to avoid snoring, and thereby improving obstructive sleep apnea in those who are willing to wear the dentures during sleep.

[0041] According to another additional but optional embodiment of the present invention, the patient's natural teeth or denture approximations may be sufficient for the purpose of making a splint set for mandibular advancement, using a clamping method rather than a full fitting method, providing a preventive measure to avoid snoring and thereby improving obstructive sleep apnea.

[0042] In summary, the snoring and obstructive sleep apnea prevention device of the disclosed invention generally provides considerable improvements and advantages over those described in the prior art, particularly as an optional accessory to dentures. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 A shows a photographic view of a typical conventional complete denture set.

[0044] Figure 1 An overall assembled view of an embodiment of the present invention is shown, which has an upper complete denture and a lower complete denture connected by a pair of strips.

[0045] Figure 1 B shows a view of a typical strip connecting the maxillary and mandibular dentures.

[0046] Figure 1 C shows Figure 1 Cross-section of B.

[0047] Figure 2A Representative sets of strips of varying lengths are shown to achieve different distances of mandibular advancement.

[0048] Figure 2B , Figure 2C , Figure 2D Alternative embodiments of the configuration of the strip and the shape of the pin head are shown, which offer advantages in terms of ensuring fixation of the strip and ease of replacement.

[0049] Figure 2E Shown is a cross-section of a typical multi-layered strap construction, with a stronger wire material as a core reinforcement for increased durability and flexibility.

[0050] Figure 3 The punch and die for the blanking method are shown as an alternative strip manufacturing method to achieve economies of scale.

[0051] Figure 4 An overall assembled view of an embodiment of the present invention is shown having a typical ISD set including an upper jaw portion, a lower jaw portion, and a pair of straps connecting the upper jaw portion and the lower jaw portion to achieve the desired mandibular advancement.

[0052] Figure 5A schematic diagram of an optional additional production and business process is shown for generating additional revenue by offering secondary discounted priced units to patients who order primary dentures. DETAILED DESCRIPTION

[0053] The general diagram of a conventional complete denture set is shown in Figure 1 A is shown in a photographic view of a typical set of A. This set is well known in the art as an upper or maxillary denture and a lower or mandibular denture. Each denture has a denture base, a denture flange, a denture side and denture teeth.

[0054] Figure 1 The construction of the mandibular and maxillary dentures in relation to the user's mandible and maxilla, respectively, is shown with the locations of different anatomical sites of interest indicated in view of the disclosed inventive aspects for securing a strip to achieve mandibular advancement to reduce snoring or OSA. The user's mandible is shown in an open position so that the interior portion of the user's mouth can be seen. The mandible has a lower gingival (also known as gum) portion 10 placed on a bone structure 11 in the mandible. The bone structure extends to the back to become the temporomandibular joint (TMJ) 15, including what is known in the art as the condyle 12, fossa 13 and articular disc 14. The mandibular denture 20 is placed on the lower gum 10 in a reasonably firm but comfortable fit and remains fixed during the user's daily activities such as speaking, chewing, etc. In a standard denture that does not use any implants to secure the denture to the mandible, the shape and fit between the mandible and the mandibular denture serve as retention.

[0055] The user can often choose to increase the level of retention. For example, by inserting or applying a biocompatible, human-safe glue material between the denture 20 and the gums 10 that has several properties: for example, zinc-free, impermeable, provides a soft cushion, seals to prevent the ingress of food particles, exudate control, uses natural ingredients such as gum wax, beneficial herbs and vitamins. There are several glue products available, such as, Denture adhesive paste (Manufacturer: PrestigeConsumer Healthcare, Irvington, NY; Source: ), Ultra-strong and durable denture adhesive ( Cincinnati, Ohio, USA Sensitive adhesive (CuttingEdge International, LLC, Los Angeles, California, USA), Instant Smile TM Secure Fit Adhesive (Billy Bob Products Inc., Hardin, IL, USA), Super Dentures and topical adhesive paste (Glaxo Smith Kline, Philadelphia, Pennsylvania, USA), Denture adhesive paste (Glaxo SmithKline, Bulgaria; Source: ), Y-Kelin denture adhesive paste (Anhui Kelin Health Technology Co., Ltd., Bengbu, Anhui Province, China), Lower denture liner kit (OTC Dental Inc., Vancouver, WA, USA), as well as many other manufacturers or sources.

[0056] According to reported studies, good average retention forces can be obtained using glue between the denture and the gums, for example, ranging from 16.66 ± 7.32 lbs for milled denture bases to 12.19 ± 6.15 lbs for conventional heat-polymerized denture bases (AlHelal, Abdulaziz Abdullah, "Comparison of Retention of Milled Denture Bases and Conventional Denture Bases: A Clinical Study" (2016), Loma Linda University Electronic Theses, Dissertations and Projects, 323). Our experimental tests showed that 3D printed dentures provide better retention, or at least comparable retention to milled denture bases. We found this retention force to be sufficient to withstand mandibular advancement forces reported in the art, which are approximately 1 to 1.2 Newtons per millimeter of mandibular advancement (e.g., 1.18 Newtons per millimeter according to J Cohen-Levy, B Pételle, J Pinguet, E Limerat, B Fleury, Sleep Breathing, May 2013; Vol. 17(No. 2): pp. 781-9, doi: 10.1007 / s11325-012-0765-4. Published online (Epub): Sep 11, 2012).

[0057] The mandibular denture 20 includes an outer wall or flange 21, an outer ridge or border 22, and an inner ridge or border 23. A cavity, referred to in the art as a trough, is formed between the outer wall and the inner wall, which is fitted on the lower gum 10. The tooth group 25 replacing the natural teeth, termed in the art as (starting from the rear or temporomandibular joint side, the tooth group (one on the left and one on the right)) the second molar, the first molar, the second premolar, the first premolar, the canine or cuspid, the lateral incisor, and the central incisor (the frontmost tooth group), are symmetrically embedded in the mandibular denture in a U-shaped configuration. This is in view of the mainstream trend that there is no third molar or wisdom tooth at the rearmost position, like the natural teeth that the dental profession recommends to be extracted, so there are a total of 14 teeth in the mandibular denture.

[0058] Similar to the mandibular denture 20, the maxillary denture 30 includes an outer wall or flange 31, an outer ridge or border 32, and an inner ridge or border 33. A cavity, known in the art as a groove, is formed between the outer wall and the inner wall, which fits on the upper gum 16. Typically, an impression of the upper palate of the user's mouth is obtained to provide a bridge between the left and right side walls of the inner wall in the maxillary denture. This bridging portion, known as the palate 34, is typically in close contact with the user's upper palate, helping to improve the retention of the maxillary denture. The maxillary denture 30 is placed on the upper gum 16 with a relatively firm but comfortable fit and remains fixed during the user's daily activities (such as speaking, chewing, etc.). In a standard denture that does not use any implants to fix the denture to the maxillary bone, the shape and fit between the maxillary bone and the maxillary denture and the palate contact play a role in retention. The user can typically choose to increase the level of retention, for example, by inserting or applying a biocompatible, human-safe glue material between the denture 30 and the gums 16, which has the properties mentioned above in the context of the mandibular denture. The tooth group 35 replacing the natural teeth, termed in the art as (starting from the posterior or temporomandibular joint side, the tooth group (one on the left and one on the right)) the second molars, first molars, second premolars, first premolars, canines or cuspids, lateral incisors and central incisors (the most anterior tooth group), are symmetrically embedded in the maxillary denture in a U-shaped configuration. This is in view of the mainstream trend of not having third molars or wisdom teeth in the rearmost position, like the natural teeth that the dental profession recommends to be extracted, so there are a total of 14 teeth in the maxillary denture.

[0059] The position 51 on the right side wall 31 of the user's maxillary denture 30 and the position 52 on the right side wall 21 of the user's mandibular denture 20 illustrate Figure 1 B and Figure 1 C shows the connection position of the pin 45. Similarly, the position 55 on the left side wall of the user's maxillary denture 30 and the position 56 on the left side wall of the user's mandibular denture 20 illustrate Figure 1 B and Figure 1 The connection position of the pin 45 shown in C. The pin can be integrated with the corresponding denture body while the denture body is manufactured by molding, milling, 3D printing or additive manufacturing or other manufacturing methods. Alternatively, other methods can also be used, such as by gluing, fitting into the receiver hole, or screwing into the receiver threaded hole if there is a matching thread on the pin, or a combination of the above methods to fix the pin to the denture body. Figure 1 B shows a view of the strip 40 assembled with the denture using pins 45, viewed from the front of the wall of the denture.

[0060] Figure 1 C shows Figure 1B is a cross-sectional view of the assembly, wherein a pair of pins 45 having pin heads 46 are used to hold or secure the strip 40 to the upper and lower dentures 30, 20. Figure 1 In the cross section AA shown in C, the pin and the pin head are not cut away. In one embodiment of the present invention, the pin head 46 can be an integral part of the pin 45. In another optional embodiment of the present invention, the pin head 46 can be attached to the pin 45 by, for example, threads, snap fit, or other methods. Figure 1 B and Figure 1 In the embodiment shown in C, the shape of the pin and the shape of the pin head are shown as cylindrical, however, those skilled in the art will appreciate that there may be other conceivable shapes, and all of these shapes are included in the present invention. Figure 2D Effective adoption of some of those shapes is shown and described in the following paragraphs.

[0061] Figure 2A A set of 4 different lengths of straps 40 are shown. The different length sets enable customization of the amount of mandibular advancement that may be most effective for a particular user. Typically, the relative positions of the pins 45 secured to the mandibular denture 20 and the maxillary denture 30 are such that maximum mandibular advancement is obtained with the shortest straps, while minimum mandibular advancement is obtained with the longest straps. Different strap lengths may be tried between these to optimize the amount of mandibular advancement that is most effective for a particular user, taking into account factors such as patency of the airway passage and comfort of use (including reduction or management of side effects such as temporomandibular joint (TMJ) pain). Optionally and preferably, the configuration of the strap 40 shown in the drawings has a relatively thick raised area around the pin hole to provide better strength and therefore tear resistance, since the mandibular advancement force reported in the art is approximately 1 to 1.2 Newtons per millimeter of mandibular advancement (e.g., 1.18 Newtons per millimeter, according to J Cohen-Levy, B Pételle, J Pinguet, E Limerat, B Fleury, Sleep Respiration, May 2013; Vol. 17(No. 2): pp. 781-9, doi: 10.1007 / s11325-012-0765-4. Published online: Sept. 11, 2012, as cited above). It will be appreciated by those skilled in the art that there may be other numbers of straps, 2 to 10 or more or even a single strap, pre-optimized in a set before delivery to the user, and all such possibilities are within the scope and spirit of the present disclosure.

[0062] Figure 2BA set of 4 different lengths of another optional construction of the strip 40 is shown, in which there is a slot. The set of different lengths enables customization of the amount of mandibular advancement that may be most effective for a particular user. Typically, the relative position of the pins 45 fixed to the mandibular denture 20 and the maxillary denture 30 is to obtain the maximum mandibular advancement using the shortest strip, while the minimum mandibular advancement is obtained using the longest strip. Taking into account factors such as the patency of the airway passage and the comfort of use (including reducing or managing side effects such as temporomandibular joint (TMJ) pain), different strip lengths can be tried between these to optimize the amount of mandibular advancement that best suits a particular user. Optionally and preferably, the construction of the strip 40 shown in the present figure has an elongated groove connecting the pin hole to provide sliding between the pin and the elongated groove, thereby providing better flexibility in the movement between the maxilla and mandible in the forward and backward, upward and downward, and lateral (left and right) directions. Those skilled in the art will appreciate that there may be other numbers of strips, 2 to 10 or more or even a single strip, pre-optimized in a set before delivery to the user, and all of these possibilities are within the scope and spirit of the present disclosure.

[0063] Alternatively, and in addition to the constructions described so far, Figure 2C Circular, oval and rectangular portions of the groove or slot portion of increased size at the middle portion of the strip are shown. This larger groove in the slot of the strip is intended to allow the circular, oval or rectangular head 46 of the pin 45 to come out of the strip, thereby facilitating the replacement of the strip. This construction of the present invention is adopted to improve the problem of the pin hole or the slot connecting the pin hole being too large to facilitate the undesirable disengagement between the pin and the strip when replacing the strip. By providing a larger groove only in the middle portion, disengagement when used in the user's mouth is avoided. Since the strip needs to be replaced only outside the user's mouth, the maxillary denture and the mandibular denture can be freely moved to a relative position so that the pin can enter the wider groove in the middle of the strip to facilitate the removal of the strip from the pin. The accompanying drawings show that the outer width of the strip is increased to maintain the strength in the middle of the strip.

[0064] Figure 2D Different shapes of pin heads 46 are shown, namely circular, oval and rectangular cross-sections, as shown in end view-P, while in most cases the pins are generally circular in cross-section.

[0065] An alternative but additional construction of the strips has stronger reinforcing threads embedded within the relatively weaker strip material to address problems encountered in trials, namely strip tearing or breaking. This has particular relevance and advantage to the present invention, wherein the strips are made of a flexible material, such as one of the acceptable biocompatible elastomers (Saliterman, Steven S., "Introduction to Medical Device Prototypes: Medical Device Polymers", Report, Department of Biomedical Engineering, University of Minnesota, USA); and the reinforcing threads may be made of a stronger material, such as ( Headquartered in Wilmington, Delaware, USA, and manufactured by Advanced Fibre Systems in Virginia, USA). Figure 2E (Not to scale, indicative only) shows a cross-sectional view of a typical multi-layer strip construction, with a stronger wire material reinforcement as the core to achieve increased durability and flexibility. The circular cross-section of the reinforcement wire 41 can be seen embedded within the strip cross-section. The combination of strength and flexibility allows relative movement of the mandibular and maxillary portions of the denture in multiple directions in 3D space (i.e., forward and backward, upward and downward, left and right). The multi-layer structure can be achieved by several alternative manufacturing methods, such as molding, 3D printing or other state-of-the-art available methods that are effective for this application.

[0066] Mass production of the strips may be optional to exploit manufacturing economies of scale, but another additional approach is being taken as an alternative to a stronger reinforced strip construction. Figure 3 A perspective view showing the construction of a typical punch set, showing the end profiles of punches 310 and 320, which can be used to perform a stepwise two-step blanking method using different punch and die sets (die not shown in the figure) as an alternative manufacturing method for strips (e.g., Figure 2C The third of the shape options shown in the figure) can be used to achieve economies of scale whereby large quantities of inexpensive spare strips can be provided rather than stronger and more expensive strips. It will be appreciated by those skilled in the art that the punch-die set includes a closely slidable adapting cavity in a die which receives a correspondingly shaped protrusion called a punch, and the relative impact between the die and the punch pierces a portion of the sheet material of interest placed between the punch and the die. In the case shown, the perforated portion produced by the first set of punch-die interactions will produce an intermediate portion as a blank, while the second set of punch-die interactions will produce a useful portion of the intended strip and a waste or discarded portion corresponding to the shape of the slots or grooves in the strip. We have found that biocompatible materials, such as those readily available in sheet form, are ( Headquartered in Wilmington, Delaware, USA), is a suitable raw material for this blanking method.

[0067] Although the drawings and descriptions in this invention have presented complete maxillary and mandibular dentures in detail, we have developed several additional and optional embodiments that are covered by the scope and spirit of the entire invention. For example, an embodiment of the present invention has a typical RPD set, including a maxillary portion, a mandibular portion, a gap clasp, a pair of multiple circular clasps, and a pair of strips connecting the maxillary portion and the mandibular portion to achieve the desired mandibular advancement. A clasp is a device that secures a partial denture with the help of the remaining natural teeth in the jaws of a person. The terminology of different types of clasps is known in the denture related field, but to the best of our knowledge, has not been effectively adopted or used in oral braces for obstructive sleep apnea or anti-snoring devices. We have experienced and discovered the forces that different types of retainer / clasp assemblies of unique designs and arrangements can withstand without glue to have sufficient retention to withstand the mandibular advancement forces that are actually quite small. This has been found to be applicable to several retaining ring designs, for example, circumferential (circular or Akers type) retaining rings, annular retaining rings, gap (double Akers type) retaining rings, "C" type retaining rings (hairpin or reaction force type), etc.

[0068] Another optional variation of the embodiment described above is one in which a temporary clearance collar is employed to enable the wearer's tongue stop to limit the tongue from sliding backwards and causing airway obstruction.

[0069] In another alternative and additional variation of the embodiments discussed thus far, a combination of multiple temporary clasps is employed to facilitate adjustable mandibular advancement with or without the need for straps.

[0070] Furthermore, in another optional variation of the above embodiment, a combination of multiple temporary clasps is employed to facilitate adjustable mandibular advancement without the need for straps, and additionally provide a tongue stop for the wearer to restrict the tongue from sliding backwards and causing airway obstruction.

[0071] Furthermore, another alternative embodiment of the present invention has a typical ISD set including an upper jaw portion, a lower jaw portion, and a pair of straps connecting the upper jaw portion and the lower jaw portion to achieve the desired mandibular advancement. Figure 4Typical locations of implant pins 810 on the lower gum 10 of the mandible and implant pins 820 on the upper gum 16 of the maxilla above the bone structure 11 are shown, which are used to secure the denture to the wearer's jaw, essentially acting to retain the denture without the use of adhesives. The denture has mating holes that slidably and tightly receive the corresponding implant pins to form a good connection and thereby retain the denture on the gums. These dentures have been found to have higher retention force capabilities than adhesive-based retention, and thus can easily overcome mandibular advancement forces. It will be appreciated by those skilled in the art that the number of implants and their locations depend on several factors, such as jaw bone density, jaw bone loss, bone grafting, etc.; therefore, while 2 to 4 implants per jaw are typical, more implants may be required in some cases, for example, in some cases, 12 to 16 dental implants have been found to be necessary. These numbers of implants are sufficient to withstand the mandibular advancement forces of approximately 1 to 1.2 Newtons per millimeter of mandibular advancement, considering that the required advancement is usually within 5 mm. Typically, the number of implants required for the dual purpose of conventional denture retention for chewing and mandibular advancement is the same or close to the number of implants required for the single conventional purpose of denture retention for chewing only.

[0072] Furthermore, in another optional but additional variation of the above embodiment, a temporary clearance snap ring is employed to facilitate the wearer's tongue stop to restrict the tongue from sliding backwards and causing airway obstruction.

[0073] Furthermore, in another optional but additional variation of the above described embodiment, a combination of multiple temporary clasps is employed to facilitate adjustable mandibular advancement with or without the need for straps.

[0074] Furthermore, in another optional but additional variation of the above described embodiment, a combination of multiple temporary clasps is employed to facilitate adjustable mandibular advancement with or without the need for a strap, and further provides a tongue stop for the wearer to restrict the tongue from sliding backwards and causing airway obstruction.

[0075] Additionally, but alternatively, a general version of the present invention utilizing a flexible clasp approach has also been invented that can be worn over dentures or natural teeth to facilitate an anti-snoring measure due to its light weight and easy attach-detach configuration.

[0076] Furthermore, in another optional but additional variation of the above-described embodiment, another general version of the present invention utilizes a flexible clasp method to enable continuous mandibular adjustment, which due to its lightweight and easy attach-detach construction can be worn over dentures or natural teeth to facilitate implementation of anti-snoring measures.

[0077] Furthermore, another optional but additional universal version of the present invention utilizes a flexible clasp approach, which may also be elastic to enable continuous mandibular adjustment and have elastic features, and due to its light weight and easy attach-detach construction, may be worn over dentures or natural teeth to facilitate anti-snoring measures, enhance the wearer's comfort, and allow jaw movement.

[0078] In addition, another optional but additional general version of the present invention utilizes a reactive latch mechanism to achieve mandibular advancement only after the user falls asleep, causing the mandible to over-relax relative to the upper jaw to facilitate anti-snoring measures, enhance the wearer's comfort, and allow a natural or moderately relaxed jaw position at the beginning of sleep.

[0079] Figure 5 A schematic diagram of an optional additional inventive method 1500 is shown, which includes providing economical production of auxiliary units for patients who order primary partial or full mouth, removable or permanent dentures, at a discounted price, which can serve a cosmetic function as well as an anti-snoring function. This also illustrates the effective deployment of business processes to promote primary denture sales and / or generate additional revenue through secondary denture sales. This innovative method obtains intraoral information 1510, which may involve the use of traditional mold materials, such as impression materials and related equipment, to capture the structure of the user's mandibular and maxillary gums, or in the case of removable partial dentures (RPDs) in addition to the gums and the structure of the adjacent teeth. Alternatively, thermal, chemical or catalytic plastic materials can be used to obtain the impression. Optionally, other alternatives can be adopted, such as using an imaging device to scan the user's gums or teeth or scanning the mold. This information 1520 is necessary and sufficient for the manufacture of partial or full mouth, removable or permanent dentures, and can be effectively used or adopted for the manufacture of primary dentures 1540 and / or secondary dentures 1590. Manufacturing methods 1530 may include computer-aided design (CAD) and computer-aided manufacturing (CAM), including different options such as 3D printing, forming, thermoforming (such as injection molding), or milling.

[0080] Upon delivery of the primary denture ordered by the user, or before, during, or after the ordering process, an optional sleep study 1550 may be offered to the user. The sleep study may include any of the different levels of sleep studies (level 1, level 2, level 3, level 4) conducted in a sleep laboratory or at home. With or without this optional sleep study, the user of the denture may be offered a secondary denture at a discounted price. This offering method step 1560 involves advice and counseling 1570 on the advantages of a secondary denture set to be worn during nighttime sleep, which may be an exact replica of the primary denture, or alternatively and preferably, a simpler, lighter version with provisions for increased exposure of the gums to air, as the purpose of such a secondary denture is not to chew food. In addition to serving a cosmetic purpose to avoid the embarrassing situation in which the user may be exposed to familiar or new acquaintances without the denture unprepared, the secondary denture also serves the important role of an anti-snoring device. Even if the user is not aware or has not been formally diagnosed with a sleep disorder, whether knowingly or unknowingly, the important function of the secondary denture is the motto of prevention is better than cure 1580. Once the user is convinced of the benefits of purchasing the secondary denture at a discounted price, the necessary information 1520 available earlier for the primary denture product can be advantageously reused in the manufacturing method 1530 of manufacturing the secondary denture 1590. Although the sleep study 1550 is only optional, if the user wishes to undergo a sleep study, related additional equipment for the sleep study, such as various biosensors 1551, a sleep application 1552, and a kit 1553, the kit 1553 including one or more sleep masks, earplugs, cleaning kits, bite repositioners, jaw position measurement tools, and chewing gum, can also be optionally provided and used. The biosensors 1551 used can be one or more biosensors configured to measure one or more sleep parameters, wherein the one or more sleep parameters are selected from heart rate, respiratory rate, head movement, body movement, bite force, body temperature, blood sugar level, actigraphy, blood oximetry, apnea hypopnea index (AHI), peripheral arterial tone (PAT), cardiac data, chest expansion, respiratory airflow, sleeping position, patient compliance, and snoring.

Claims

1. A system for preventing or helping to reduce snoring or obstructive sleep apnea, comprising: The mandibular portion of the denture set; the maxillary portion of said denture set; A device for retaining the mandibular and maxillary portions of a denture within a person's mouth to enable mandibular advancement.

2. The system of claim 1, wherein at least one pair of two pins and at least one strap are employed to enable the mandibular portion of the denture set to be maintained in an advanced position relative to the maxillary portion of the denture set.

3. A system according to claim 2, wherein a set of strips of different lengths are used to vary the amount of mandibular advancement.

4. The system of claim 2, wherein the strip or strips may have slots or grooves to allow relative movement between the mandibular portion and the maxillary portion of the denture.

5. The system of claim 1, wherein the denture set can be provided as a denture without implants, such as a removable partial denture or a removable complete denture.

6. The system of claim 5, wherein retention of the denture is enhanced by use of glue between the denture and the gums sufficient to withstand mandibular advancement forces.

7. The system of claim 1, wherein the denture set can be provided as any of implant-supported dentures, such as a single-tooth implant, multiple teeth on an implant-supported bridge, or multiple teeth on an implant-retained denture.

8. The system of claim 1, wherein one or more components are made of biocompatible nylon.

9. The system of claim 1, wherein at least one or more components are manufactured by 3D printing or additive manufacturing methods.

10. The system of claim 1, wherein all components are manufactured by 3D printing or additive manufacturing methods.

11. The system of claim 2, wherein the strip or strips are made by a blanking process.

12. The system of claim 2, wherein the strip or strips are made of a multi-layer hybrid structure, wherein for example The stronger material of the thread is the core to provide strength, on which is coated a biocompatible material, such as Nylon-12, to allow for a combination of strength and flexibility.

13. A system according to claim 12, wherein the combination of strength and flexibility facilitates relative movement of the mandibular portion and the maxillary portion of the denture in multiple directions in 3D space, in particular forward and backward, upward and downward, left and right or other possible intermediate directions.

14. A method for increasing the use of the anti-snoring and obstructive sleep apnea reduction device according to claim 1, obtained by providing the following steps: Obtain necessary and sufficient intraoral information for denture fabrication; manufacture and supply primary denture sets; recommends and provides secondary denture sets; Following the user's consent to fabricate the secondary denture set using previously obtained intraoral information; Secondary denture sets are available.

15. The method of claim 14, wherein the secondary denture set is provided at a discounted price for cosmetic or anti-snoring purposes or both.

16. The system of claim 5, wherein retention of the denture sufficient to withstand mandibular advancement forces is enhanced by the use of at least one clip or clasp between the partial denture and one or more natural teeth.

17. The system of claim 1, wherein at least one temporary clasp or optionally a combination of multiple temporary clasps is employed so as to facilitate adjustable mandibular advancement.

18. The system of claim 1, wherein at least one temporary clasp is a flexible or resilient clasp or a gap clasp that additionally or alternatively provides a stop for the wearer's tongue to limit it from sliding backwards.

19. The system of claim 17, wherein the system can be worn over dentures or natural teeth due to its flexibility, light weight, and easy attach-detach configuration.

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