DK177992B1

DK177992B1 - Successive Adjustable Mandibular Advancement Device For Preventing and Treatment of Snoring And Obstructive Sleep Apnea

Info

Publication number: DK177992B1
Application number: DK201400149A
Authority: DK
Inventors: Natashia Ingemarsson Matzen
Original assignee: Natashia Ingemarsson Matzen
Priority date: 2013-06-02
Filing date: 2014-03-17
Publication date: 2015-02-16
Also published as: CA2912311C; CN105246437A; WO2014194910A9; BR112015029484B1; JP6387087B2; EP3003234A4; EP3003234A1; US20140352700A1; RU2657847C2; RU2015148422A; US9545331B2; WO2014194910A1; DK177809B1; JP2016519975A; BR112015029484A2; AU2014277344A1; EP3003234B1; CA2912311A1; DK201400149A1; SG11201509395WA

Description

Fl ELD OF I NVENTI ON

The current invention relates to an adjustable mandibular advancement device which by virtue of a successive (continuous) mechanism advances the mandibular relative to the maxilla in order to prevent or reduce Snoring and/or Obstructive Sleep Apnea Syndrome (OSAS) during sleep. The adjustability is accomplished by the intrinsic embedded mechanism in the two members in conjunction or separately in either of the members relative to the other.

Background of the invention

Snoring and Obstructive Sleep Apnea are generally known today as the same disease on a continuum of the sleep disorder severity scale. Starting at the modest degree of snoring ending in the fulminate obstructive sleep apnea condition, is known as a fact.

As the disease is closely related to a large variety of physical and mental conditions, treatment is of outmost importance as soon as possible.

Whereas the snoring condition is characterized by the sounds developed by vibrating tissues in the most dorsal area of the pharynx, either the nasopharynx, or the oropharynx or the laryngopharynx, the obstructive sleep apnea is characterized by actual respiration arrest caused by occlusion of the pharyngeal airways.

Apnea appears when the upper airway passages are being sucked close to the rear part of the throat when the person is trying to breathe during sleep. The occlusion can be the result of suction or by the lapse of tonus in the oral soft tissues during the relaxed sleep condition.

When the occlusion is there, no air is passing through the pharynx and down to the lungs, and this is the situation called OSAS (Obstructive Sleep Apnea Syndrome).

The obstruction can happen as often as 1000 times during the night time sleep in which the body is depraved from oxygen uptake from the air into the blood stream, which eventually leads to the aggravated symptoms.

The severity of OSAS has been described in the medical literature numerous times giving cause to a number of symptoms and diseases:

General headache High blood pressure Diabetes

Hypoxic pulmonary vasoconstriction Cardiomyopathy

Pulmonary hypertonia with cor pulmonale (increased pressure in the heart-lung circuits)

Heart failure, heart arrhythmia, heart attack Day time melancholy or depression Intelligence alterations

Acid Reflux (GERD - Gastro Esophageal Reflux Disease)

Potency disturbances

Worsening of ADHD (Attention Deficit Hyperactivity Disorder), in addition to a large number of problems of a more social character, like, e.g., divorce, decreased labour activity, difficulties in keeping conversations in the track due to tiredness, etc.

Thus, compared to a normal control group without diseases, patients suffering from snoring and/or OSAS appear to have: three times as many cases of coronary heart diseases, four times as many cerebral illnesses, such as clots, twelve times as many incidents of car accidents and twice as many labour accidents due to day time sleepiness as a result of lack of sleep and/or impaired sleep quality.

Due to these conditions the life time expectancy is severely limited for these patients, and their quality of life is compromised.

The continuum of snoring diseases gives the following frequency figures: ► 40% of adults over 40 snore (approx. 87 million Americans) ► 9% of men and 4% of women suffer from some form of OSAS (approx. 30 million Americans) ► Less than 10% of OSA sufferers have been diagnosed (Approx 3 million Americans) ► Of those, less than 25% have been successfully treated.

For the above reasons, it is important to provide devices to eliminate and prevent apnea and the incipient stages thereof.

In the prior art, a number of surgical techniques for removal of the tissue involved in the obstruction have been developed, but all of these techniques seem to incur a certain invalidation of the patient and, at the same time, do not have a fully predictable effect.

Furthermore, a number of medical treatments have been tried out with predominantly deficient or sometimes even damaging effect.

Finally, the scientific literature and the patent literature disclose numerous devices for alarming the snoring patient during sleep; devices for tongue thrust, devices for forward movement of the soft palate; devices for obstructing the oral cavity (delimited by the lips), thereby engaging the sound from the snoring; furthermore, mandibular advancement splints or appliances, mouth guard-like devices for provocation of either tongue, hyoid bone or jaw position changes, thereby eliminating snoring; - all of these requiring active participation from competent professionals, such as medical doctors, dentists, etc. Among such prior art devices for or attempts to inhibit snoring, the following are of particular interest in the present context: EP 0 794 749 B1 (I ngemarsson-Matzen & Voss) discloses a jaw position-regulating oral device for preventing snoring and obstructive sleep apnea during sleep. The device consist of two members, a first member to engage with the maxillary dentition and a second member to engage with the mandibular dentition, both connected by a resilient hinge. The mechanism is embedded in the mandibular advancement relative to the maxilla. The main difference from the present patent application is the lack of adjustability of the length of the members relative to each other. WO 2013 / 032 884 A1 (Fallon & Jung) discloses a mandibular advancement device with an upper and lower member to engage the maxillary and mandibulary dentition respectively. The lower tray assembly is mated to and slidably adjustable by the patient relative to the upper tray assembly. The main difference from the present patent application is that the device lacks a resilient hinge. WO 2009 / 062 541 A1 (Magning & Magnin) discloses a mandibular advancement orthosis in which the device the comprises a unitary flexible member that can be folded on itself for interaction with the teeth of the upper and lower arches, and an interchangeable flexible strip for surrounding the teeth of the upper arch, having a length that can be modified in order to obtain the desired level of mandibular advancement. The main difference from the present patent application is that the device is regulated by detachable flexible strips and not intrinsic in the device itself. US 2009 / 0014 013 A1 (Magnin) discloses a mandibular advancement splint made of two thermoformable trays designed to envelop the upper and lower arch. The advancement splint includes an articulated frame having rigid and flexible elements immersed in the thermoformable flexible material or molded around it. The main difference from the present patent application is that the device is made by two separate members without any hinge. EP 1 719 481 A1 (Arni) discloses a mandibular advancement device with a lateral link incorporated into a mandibular protrusion device comprising an upper dental tray and a lower dental tray so as to advance or retract the lower dental arch during a vertical movement between the two. The link is adapted to be detachably accommodated in an opening of a ball pivot. The main difference from the present patent application is that the device lacks the intrinsic resilient hinge. EP 2 529 710 A1 (Ash) discloses a device for mandibular advancement in which an upper member and a lower member are interconnected by means of pivotable connection in which at least one is formed as a stud. The main difference from the present patent application is that the device is made of two separate members with detachable attachment cylinders and clamps attached to the outside of the members. CA 223 650 3 A1 (Frantz & Frantz) discloses a mandibular advancement device which uses elastic bands to pull the jaw forward. The upper part having a set of retention hooks and the lower part having a set of interchangeable slide-in posterior occlusal bite planes. The main difference from the present patent application is that the device is the use of detachable elastic bands and no intrinsic resilience in any hinge. WO 2008 / 130 413 A1 (Meade) discloses a mandibular advancement device for pulling the lower jaw forward composed of an upper and a lower member to engage the dentition, where a ball type of hook support is located on both sides of the upper tray at a forward position and a ball type of hook supports are located at a rearward position of both sides of the lower jaw. A tension coil is attached to each of the upper and lower ball type of hook supports. The main difference from the present patent application is that the device uses detachable hooks and spring coils and lack the resilient hinge mechanism. US 2013 / 001 4765 A1 (Meade) discloses a mandibular advancement device for pulling the lower jaw forward composed of an upper and a lower member to engage the dentition, where a ball type of hook support is located on both sides of the upper tray at a forward position and a ball type of hook supports are located at a rearward position of both sides of the lower jaw. A tension coil is attached to each of the upper and lower ball type of hook supports. The main difference from the present patent application is that the device uses detachable hooks and spring coils and lack the resilient hinge mechanism. WO 2011 / 115 962 A1 (Van Dyke & Tucker) discloses a mandibular advancement splint made of two trays designed to envelop the upper and lower arch. The upper appliance has a pair of adjustable wings attached to the body, and the lower has a pair of fixed wings attached to the body. The upper wings are slidable adjustable. The main difference from the present patent application is that the device is made of two separate members without any hinge and that uses detachable pivots in both upper and lower members. US 2010 / 004 380 5 A1 (Kelly) discloses a mandibular advancement device with an upper and lower member to engage with the dentition of the human. The lower dental plate having two pairs of spaced apart pillars and two removable attachable horizontal displacements inserts on the upper part. The main difference from the present patent application is that the device uses detachable vertical displacements inserts and lacks the resilient hinge mechanism. GB 2 264 868 A (Mateljan) discloses an anti-snoring device for oral use, comprising members having upper and lower surfaces which engage the user's maxillary and mandibular dental arches respectively. The upper and lower surfaces are spaced so that the mandible is placed in a forwardly offset position relative to its normal position. The spacing also tensions the masticatory muscles to maintain the device in place. The main difference from the present patent application is that the device has no capability of adjustability in antero-posterior directions, and no hinge in the back part of the device. US 2011 / 001 722 0 A1 (Lindsay et al.) discloses a self- titratable mandibular repositioning device that allows for adjusting the maintained forward position by simply biting-down to preserve the desired degree of mandibular advancement, made of a lower and an upper member to engage the dentition. The main difference from the present patent application is that the device has no resiliency of any hinge. US 2008 / 011 579 1 A1 (Heine) discloses a mandibular advancement device with an intraocclusal removable device in the form of a "U" that is placed covering all of the upper jaw teeth, wherein two steps, one in each extreme of the lower part of the element, which impede the mandible be closed completely on its normal occlusion, forcing it to produce a forward displacement of the lower jaw. The main difference from the present patent application is that the device is that this device is a one member device with no hinge and only minor protrusive force can be applied to the lower jaw and only in occlusion. US 2005 / 023 600 3 A1 (Meader) discloses a mandibular advancement device as a single piece of molded plastic with said unit modeled from four theoretical positions including a shield like anterior portion fitted and anchored between anterior teeth-gums and behind the lips. The main difference from the present patent application is that the device is a mono-block decided for prevention of lip closure. US 2010 / 030 045 8 A1 (Stubbs et al.) discloses a mandibular advancement device with an upper and lower member to engage with the dentition of the human. The members are including a cam associated with one of the jaws and a follower associated with the other jaw. The main difference from the present patent application is that the device is the lack of hinge in the posterior part. US 2008 / 009 902 9 A1 (Lamberg) discloses a mandibular advancement device composed of a maxillary main body for removable attachment to the maxillary teeth with a protrusive element extending from the central portion of the body and a mandibular removable appliance attached to the mandibular anterior teeth. The main difference from the present patent application is that the device is having a forcing mechanism on the lower jaw and lacks the posterior hinge. EP 2 491 901 A1 (Garcia Urbano) discloses regulatable intraoral mandibular advancement device for preventing snoring and sleep apnea in which a screw system is located in the central part of the connection between the upper and lower members for the engagement of the dentition. The main difference from the present patent application is that the device is operated by a non intrinsic screw and screwdriver to maintain the regulated forward position of the mandible relative to the maxilla. AU 1999 476 15 B2 (Palmisano) discloses a mandibular advancement device in which the upper jaw is firmly fitted into an upper plate and the lower jaw is firmly fitted into a lower plate, these two parts are connected by means of opposing flange components located to be lying in an area and close to the posterior teeth. The main difference from the present patent application is that the device is constructed with a pivotal mechanism and not a hinge. US 2013 / 001 476 5 A1 discloses a tongue and mandibular advancement device in which an upper member has hook supports anteriorly and a lower member has a plurality of hook support at the rearward position. The main difference from the present patent application is that the device the two member separated system without any intrinsic hinge. EP 0 337 201 discloses an orthodontic appliance comprising a first member to engage with the mandibular dentition and a second member to engage with the maxillary dentition. The two members are resiliently hinged together to keep the upper and lower jaw in a normal position. The main difference from the present patent application is that the device is the lack of adjustability in the sagital plane, thereby delimitating the usability as a snoring preventing device. WO 92/11827 discloses an anti-snoring device for oral use consisting of a horseshoe-like upper jaw member for engaging the maxillary dentition, with the downward extending flange intended to extend into the lingual vestibule in order to maintain a forward posture of the lower jaw. The main difference from the present patent application is that the device is using a forcing mechanism on the lower jaw. EP O 312 368 discloses an anti-snoring device for oral use which resembles the above-mentioned device, the main difference being the design of the airway passage. The main difference from the present patent application is that the device is using a forcing mechanism on the lower jaw. WO 92/05752 (Wu) discloses an anti-snoring device for oral use consisting of a spatial member congruent with the palate and a lower member adapted to the lingual aspects of the surfaces of the dentition in the lower jaw, hooks being attached to the occlusive plane of the device for fixing the two jaws in a predetermined relation. The main difference from the present patent application is that the device is using detachable elastics and has no resilient hinge. US 5,313,960 (Tomasi) discloses an anti-snoring device for oral use consisting of two horseshoe-like individually shaped mouthpiece portions which are connected and fixed in a predetermined position in which the lower jaw protrudes in relation to the upper jaw. The main difference from the present patent application is that the device is using a predetermined forward position of the lower jaw relative to the upper jaw, and there is no resilient hinge. US 7,910,502 B1 (Nguyen & Nguyen) discloses an anti-snoring device for oral use consisting of two horseshoe-like individually shaped mouthpiece portions which are connected and fixed by an assembly of tubes, hooks and screws to be attached to the two separate members. The main difference from the present patent application is that the device is using detachable screws, spring coils and loops to keep the mandible in a forward position, meaning that there is no intrinsic resilient hinge. Therefore the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow. DE 201 02 432 U1 (Trentepohl et al.) discloses an anti-snoring device for the oral use comprising an upper and lower member to engage with the maxillary and mandibulary dentition interconnected by an adjustable telescopic device which is attached at the outer surface of the members. The main difference from the present patent application is that the device is using detachable telescopic devices attached to the outside of the members to keep the mandible in a forward position. This means that the successive mechanism is not an embedded intrinsic part of the device. Thus the device lacks the embedded intrinsic resilient hinge. Also the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow. WO 21013 049 751 A2 (Rogers) discloses a method for use in connection with sleep-disordered breathing, of forming oral orthotic systems to position and /or stabilize a mandible of a patient includes providing an upper dental member adapted to be placed in connection with upper dentition of the patient, providing a lower dental member adapted to be placed in connection with lower dentition of the patient providing a plurality of posterior mounting structures. Each of the posterior mounting structures is adapted to be attached to one of the upper dental member or the lower dental member at a posterior, buccal position thereon. Each of the posterior mounting structures includes a plurality of positions at which one of the pluralities of connectors is attachable to the extending member. Force may be applied to the mandible of the patient via at least one of a plurality of different mechanisms via attachment of a component of the mechanism to at least one of the posterior mounting structures. The upper dental member and the lower dental member are formed, independently, from at least one polymeric material. The main difference from the present patent application is that the device is using multiple detachable mounting structures to keep the mandible in a forward position. Thus the device lacks the intrinsic resilient hinge. The upper and lower members are constructed after direct impressions of the user's teeth, and then separately in a second laboratory procedure casts the hard polymeric (acrylic) material to form congruent trays for the upper and lower jaws. As this system is using hard acrylic material it substantially differ from the present patent application in function, durability and comfort. This gives a disadvantage in regard to monetary price for the end user. Also the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow. US 2013 009 837 2A1 (Webster et al.) discloses an oral appliance for prevention of sleeping problems, including snoring, sleep apnea and bruxism. Specifically the device alters the position of the mandible and is made of a one piece device molded from a flexible polymer. Both upper and lower dental trays include inner and outer walls which should increase the contact area with the teeth. The hinge mechanism of the device includes a positive positioning system comprised of upper and lower opposed interlocking ridges. The ridges serve to create offset between the position of the upper and lower tray relative to each other, therefore advancing the user's mandible. The main difference from the present patent application is that the device is a one-piece device folded on a fixed point in the back most posterior part of the device to keep the mandible in a forward position. The interlocking ridges keep the lower and upper trays in a fixed forwarded position, thereby merely prohibits the other vice rolling possibility of the device leading into misuse of the intention of the device. Also there is no kind of neither incremental nor successive adjustability. This device is only one position protrusion of the mandible relative to the maxilla. Hence there is no individualization possibility. US 2011 022 626 1A1 (Hernandez) discloses a mouthpiece for reducing snoring. The mouthpiece includes an upper guard configured to fit over the upper teeth of the user, a lower guard configured to fit over the lower teeth of a user, a spacer assembly provided between the upper guard or the lower guard to provide an air passage at the middle section of the mouthpiece, a first adjustable assembly attached to the left side of the upper guard and the left side of the lower guard, and a second adjustable assembly attached to the right side of the upper guard and the right side of the lower guard. The first adjustable assembly and the second adjustable assembly are operable to move the lower guard relative to the upper guard. The main difference from the present patent application is that the device is using detachable blocks and screws devices to keep the mandible in a forward position. Although the device depicts a kind of hinge (flexible coplanar connectors), this hinge, detachable assembly, is merely decided for avoiding sharp edges at the posterior part of the two members and for ease and economy of manufacture , and can not function as an actual durable active hinge due to the fact that the screws in the blocks are rigid. In conclusion, the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow. WO 01 302 60 A1 (Bergersen) discloses a patent application as an intra-oral appliance for repositioning the user's mandible anterior to the user's maxillary teeth, thus opening the user's oral, pharyngeal passageway preventing snoring and sleep apnea. The appliance is two U- shaped plates joined to form a hinge.

The lower plate has lingual tabs which are employed to help position the appliance. The main difference from the present patent application is that the device is completely lacking any kind of successively enlargement or diminution adjustability. Also the WO 01 302 60 A1 is merely a transcription of the original patent ΕΡ0 794 749 B1 (Ingemarsson-Matzen & Voss) except the lingual tabs which in the original version is a solid moldable block. US 7,810,510 B1 (Nguyen & Nguyen) discloses an anti-snoring device for oral use consisting of two horseshoe-like individually shaped mouthpiece portions which are connected and fixed by an assembly of tubes, hooks and screws to be attached to the two separate members. The main difference from the present patent application is that the device is using detachable screws, spring coils and loops to keep the mandible in a forward position, meaning that there is no intrinsic resilient hinge. As the device uses detachable elements and thus do not take advantage of the possible effect of the current applications intrinsic embedded posterior hinge, the patent differs significantly from the present application. Therefore the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow.

Disclosure of the I nventi on

While the above devices represent attempts to solve the snoring and apnea problems, they are all rather complicated in their design and most of these require the interaction of a professional team in their individual design. Furthermore, they are rather discomfortable for the wearer, and they do not appear convincing with respect to their capability of achieving an effective and long-lasting anti-snoring effect.

Thus, there is a demand for a relatively comfortable device which provides a high degree of inhibitory effect on snoring during even long sleeping periods, such as overnight, without adverse effects on the structures involved, and which at the same time is easy and simple to use and wear for normal non-skilled persons.

The present invention provides such a device.

The adjustable anti-snore device according to the invention comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibulary dentition of the human, the upper and lower members being resiliently or mechanically hinged together, wherein the resiliency of the hinging is adapted to allow the physiological movement of the lower jaw in the sagital plane while retaining a forward position of the lower jaw relative to the upper jaw and thereby keeping the airway passage in the nasopharynx, the oropharynx and the hypopharynx substantially free of occlusion, while at the same time embody the adjustability in the form of a successive mechanism.

The device according to the invention combines three essential functions: the forward positioning of the lower jaw relative to the upper jaw, the hinging, and the adjustability of the sagital relation between the two members. As will be explained below, the forward positioning of the lower jaw is essential to prevent occlusion of the airway passage in the pharyngeal space during sleep. The resilient or mechanically hinging makes it possible and realistic to maintain the forward positioning of the lower jaw even during movements in the sagital plane which unavoidably occur during sleep. And the adjustability makes it useful for even the smallest and the largest person wearing the device. This essential combination of features which ensures constant non-constricted airflow and unrestricted movement in the sagital plane and thereby ensures a constant efficient function without risk of the device falling out of the mouth of the user and without any substantial discomfort together with the adjustability which even allows some horizontal movements, distinguishes the device according to the invention from all of the abovementioned prior art devices.

The device according to the invention may be made of any material, such as metal, alloy, wood, plastics, etc. provided that the device made feels soft and comfortable in the mouth without any constriction or damaging of the tissue, such as gums, tongue, teeth, but at the same time is sufficiently capable of retaining its shape and of exerting a sufficient resiliency towards the muscular tension and forces acted upon the jaws so that it will maintain the lower jaw in the anterior position while allowing normal movements during sleep. The material used for the device according to the invention should not contain any allergens or other kind of toxic ingredients.

The device according to the invention is preferably made of a resilient non-toxic plastics material, such as a polyvinyl resin, including a vinyl acetate-ethylene copolymer such as poly (ethyl vinyl acetate), or a polyolefin such as polyethylene or polypropylene.

It is particularly preferred that the resilient non-toxic plastics material is a thermoplastic material, such as a cellulose derivative, a vinyl polymer, a polystyrene, a polyamide, an acrylic resin, etc., which can be shaped to adapt to an individual dentition by moderate heating, such as heating to a temperature above normal human body temperature, that is, a temperature of at least 40°C and at the most 80°C, e.g. about 70°C. The material presently most preferred by the inventor is ethylene vinyl acetate copolymer.

The device according to the present invention may be manufactured by plastics molding, such as cold molding, compression molding, injection molding, etc. The manufacturing method presently most preferred by the inventor is injection molding.

The upper and lower members are preferably integrated with each other through resilient hinges made of the same material as the upper and lower members. However, the hinges may be reinforced and their resiliency enhanced by insertion, such as cast in, etc., into the hinges of a resilient member, such as a resilient plastics member, a metallic resilient member, such as a flat spring, a laminated spring etc. etc., or simply by a mechanical connection.

The adjustability according to this invention, being embedded or glued, gilded or otherwise attached to the membering parts for the engagement of the dentition, in the upper maxillary member, the lower mandibulary member or both members at the same time, being either incremental or successive is a major novelty and is unique for this device.

As it will be understood the adjustability is embedded in the anterior parts of the upper and / or lower members of the device thus keeping the posterior resilient or mechanic hinge intact.

The adjustability of the protrusion of the mandible relative to the maxilla is made adjustable by the means of embedding a positive structure in either the forward moving part or the device and a negative structure in the stable part of the device or vice versa. The positive part may be constructed as a rod or alike, whereas the corresponding negative structures would be cylinders and alike in this aspect. Other configurations may apply. Thus the adjustability will express itself as a successive (stepless) adjustability.

When the successive design is used, a special rod can be supported for the consumer that allows fixation of the desired position of the forwarded device. Said special rod and alike may be made of a heat conducting metal insulated with a non-heat conducting hand piece, so as not to damage the fingertips of the user when heating the rod and penetrating the material of the invention at the desired position. A particularly preferred way of shipping the device according to the invention to the end consumer is as a kit comprising the device and a temperature indicator adapted to indicate a temperature change to an elevated temperature at which the material of the device can be shaped. This makes it simple and safe for the end user to mold the device to conform to his or hers specific dentition simply by heating the relevant domain of the device in water at the temperature of which is kept in the correct temperature range for the material in question by using the indication of the temperature indicator.

It should be understood that the use of the anti-snore device according to the invention is not limited to prevention or reduction of snoring or OSAS but the device is applicable in any situation where it is desirable to secure free airway passage in human beings, such as during recovery from anesthesia, during unconsciousness, etc.

The unique combination of posterior resilient / mechanic hinging, dentition engagement and adjustability discussed above can also, according to another aspect of the invention, be utilized in a device for relieving guided transpositions of the jaws.

In this latter aspect, the invention relates to an orthognatic function device comprising an upper member adapted to engage with the maxillary dentition of a human and a lower member adapted to engage with the mandibulary dentition of the human, the upper and lower members having bases which prevent direct contact between opposing teeth, thereby eliminating guided transposition of the jaw relation and the upper and lower members being resiliently hinged together in such a manner together with the adjustability that the lower jaw of the human is kept positioned in a normal position relative to the upper jaw, allowing vertical movement and, in the occluded intercuspidal position, allowing horizontal movement so that the temporo mandibular joint is kept substantially in its resting position, both when the lower jaw is at rest and when it is working.

It will be understood that also in this aspect, the resiliency of the hinging should be adapted to allow the physiological movement of the lower jaw in the sagital plane, and that the above comments concerning selection of suitable materials, manufacturing method, and adaptation to the individual dentition by shaping the material in a softened, e.g. heat-softened, condition apply also to this aspect of the invention.

Thus, the orthognatic aspect of the invention provides a completely new philosophy in relieving temporo mandibular joint disorders caused by irregular dentition: In contrast to known orthognatic devices, the orthognatic device according to the invention is hinged in such a way that no interference between the upper and lower members can occur, thereby alleviating symptoms caused by abnormal interference from irregular dentition. Furthermore, tensions caused by tooth grinding and clenching are alleviated. At the same time, this orthognatic device is much simpler to adapt to the individual needs of the person in question than conventional orthognatic devices, and it can even be used by the individual consumer without assistance by any professional.

In the following, the successive mandibular advancement anti-snoring device aspect of the invention will be explained in further detail with reference to the accompanying drawings.

DESCRI PTI ON OF FI GURES

In the figures and drawings in which,

Fig. 1 Shows the Successive version of the mandibular advancement device in which a sliding system is indicated (the sliding system here is in the form of a "dovetail guide structure"). The device is seen from an oblique perspective from the bottom part

Fig. 2 Shows the Successive version of the mandibular advancement device in an oblique perspective from the top part, in which a sliding system is indicated

Fig. 3 Shows the Successive version of the mandibular advancement device in a perpendicular perspective, in which a sliding system is indicated with its maximum elongation

Fig. 4 Shows the sectional drawing of the device at line A in fig. 3 at its maximum elongation at the midline of the device

Fig. 5 Shows the sectional drawing of the device at line B in fig. 3 at its maximum elongation at the junction of the device members

Fig. 6 Shows the sectional drawing at line C in fig. 3 in which the engaging mechanism can be seen, further in detailed insert

Fig. 7 Shows the Successive version of the mandibular advancement device in which a sliding system is indicated (the sliding system here is in the form of a "dovetail guide structure"). The device is seen from an oblique perspective from the top in its detached situation

Fig. 8 Shows the Successive version of the mandibular advancement device in which a sliding system is indicated (the sliding system here is in the form of a "dovetail guide structure"). The device is seen from an oblique perspective from the top in its detached situation

Fig. 9 Shows a detailed enlargement of the negative structure of the

Successive adjustable sliding mechanism depicted as a "dovetail guide"

Fig. 10 Shows a detailed enlargement of the positive structure of the Successive adjustable sliding mechanism depicted as a positive structure

Fig. 11 Shows the Successive version of the Adjustable Mandibular

Advancement Device top view in a oblique perspective in its Maximum elongated position with visible platforms for the engagement of one part of the Velcro system. Note that the platform can also be used as one part of a gluing surface

Fig. 12 Shows the Successive version of the Adjustable Mandibular

Advancement Device bottom view in its Maximum elongated position. Note that the platform connecting the two members can also be one part of a gluing surface

Fig. 13 Shows the Successive version of the Adjustable Mandibular

Advancement Device top view in a oblique perspective in its detached position with visible platforms for the engagement of one part of the Velcro system or a glue

Fig. 14 Shows the Successive version of the Adjustable Mandibular

Advancement Device bottom view in a oblique perspective in its detached position with visible platforms for the engagement of one part of the Velcro system or a glue

Fig. 15 Shows enlarged detail of one part of the connecting platforms on either upper mandibular or lower mandibular to engage with its corresponding counterpart by Velcro system or a glue

Fig. 16 Shows enlarged illustration of the other part of the connecting platforms on either upper mandibular or lower mandibular to engage with its corresponding counterpart by Velcro system or a glue

Fig. 17a Shows the heat applicable rod tool with its discoid handle and its pin in an oblique projection from above

Fig. 17 b Shows the two parts of the heat applicable rod tool separated

Fig. 17c Shows the heat applicable rod tool with its handle and its pin from above, the A-A section describes in fig. 17 d

Fig. 17 d Shows the heat applicable in cross section from fig. 17 c in which the embedded rod is enclosed by the handle material

Fig. 18 Shows a diagrammatic representation of the limitations of the movements of the lower jaw in any direction in the sagital plane where PCP stands for the most protruded contact point of the teeth, IC stands for intercuspidal position (the maximal closing point), RCP stands for the most retracted contact position for the teeth, and MOP stands for the maximal opening point.

Fig. 19 Shows the Tubular Successive version of the Adjustable Mandibular Advancement Device shown in an activated and elongated detached view seen from a frontal oblique perspective shown in figs. 1 through 8.

Fig. 20 Shows the Tubular Successive version of the Adjustable Mandibular Advancement Device shown in an activated and elongated detached view seen from a bottom dorsal oblique perspective shown in figs. 1 through 8.

Fig. 21 Shows the Successive version of the Adjustable Mandibular

Advancement Device shown in an activated and elongated detached view seen from a frontal oblique perspective shown in figs. 1 through 11.

Fig. 22 Shows the Successive version of the Adjustable Mandibular

Advancement Device shown in an activated and elongated detached view seen from a bottom dorsal oblique perspective shown in figs. 1 through 11.

Detai led descripti on of the nomenclature used in thedescripti on of the FIGURES.

In Figs. 1-22, in which like numerals indicate like parts, the device 1 according to the invention consists of two horseshoe-like members 2 and 3 of a soft, resilient plastics material, preferably a thermoplastic material, such as an ethylene vinyl acetate copolymer, or any suitable material, hinged together by means of integrated resilient or mechanical hinges 4 and 4'. Surfaces 5 and 6 represent the lower surface of the upper member and the upper surface of the lower member, respectively. 7 indicates the lingual flange of the lower member adapted to the lingual surfaces of the lower incisors, canines and premolars, this flange 7 being the part of the device which actually forces the lower jaw forward. 8 is the facial surface of the lower member, 9 is the facial surface of the upper member, and 10 is the lingual surface of the upper member. The conjoining effect of forces exerted by the facial surface 9 of the upper member and the lingual surface 7 of the lower member keep the lower jaw in a forward position relative to the upper jaw. As the facial surface 8 and the lingual surface 10 do not exert any forces, their dimensions are rather uncritical and some embodiments of the invention may even be provided without these surfaces. No. 11 indicates the tunnel shaped space of the upper member 2 to engage with the upper dentition and 12 indicates the tunnel-shaped space of the lower member 3 adapted to engage the lower dentition. When the device is compressed to an active position, convexity 13 appears at the posterior end part of the device and a concavity 14 at the anterior part of the hinging. The occusal knots 15 are designed to prevent complete occlusion and lack of airspace between the members 1 and 2. No. 17 is the Lateral facial portion of the mandibular member at the molar and premolar area, 18 is the medial palatine portion of the maxillary member at the molar and premolar area, 19 shows the Lingual wall of mandibular member closest to the tongue, 24 is the lateral facial portion of the maxillary member at the molar and premolar area, 25 the Lingual wall of mandibular member closest to the teeth, 26 the Mandibular member part of the invention with its positive structures of the successive mechanism, 27 the Hinge member part of the invention with its positive structure of the successive mechanism, 28 is the Hinge member part of the invention with its negative structures of the successive mechanism. 29 Upper or lower member with their positive structure of the successive part, 30 shows the Successive mechanism, 31 is the Positive structure of the successive mechanism, 32 the Negative structure of the successive mechanism. No. 33 is the Successive non specified 1. member of successive mechanism, 34 is the Successive non specified 2nd member of successive mechanism. In the figs. no. 35 indicates the Platform of the fingertip handle for the heating device, and 36 is the Edge of the fingertip handle for the heating device, where 37 is the Invagination part of the handpiece for holding the metal rod, 38 is the actual Metal rod. No. 39 is the intercuspidal position (IP) in which the dentition of the mandible makes the maximal interference with the dentition of the maxilla; 40 is the protruded contact position (PCP) in which the mandible has made the maximal protruded movement from the IP position, still keeping some contact with the dentition of the maxilla; 41 is the retracted contact position (RCP) in which the mandible have made the maximal retraction from the IP position, still keeping some contact with the dentition of the maxilla, and 42 is the maximal opening point (MOP) in which the mandible has made the maximal opening movement from the IP position, all of which only being restricted by the muscles, the teeth, the ligaments and the discus involved in the temporomandibular joint system. 42 indicates the border describing the curve in which the mandible can slide open from the RCP, 43 is the border describing the curve in which the mandible can slide open from the PCP.

Claims

1. En trinløs anti-snorke og søvnapnø forhindrende mandibei fremførende anordning (1) der består af en øvre del, beregnet tii omfavnelse af det humane maksiiære tandsæt, og en nedre dei, beregnet tii omfavnelse af det humane mandibuiære tandsæt, karakteriseret ved at den øvre og den nedre dei er resiiient eller mekanisk hængslet i forhold til hinanden i den mest posteriore del af anordningen,og hvor de enkelte dele (maksiiære og mandibuiære) er trinløst forskydelige i forhold til hinanden ved hjælp af trinløse mekanismer indiejret som integrerede dele af de maksiiære og mandibuiære dele, og hvor det posteriore hængselied er adapteret ti! at følge de fysiologiske bevægelser af underkæben (mandibula) i det sagitale plan, samtidigt med at hoide en fremskudt position af underkæben i forhold til overkæben (maksilia), og derved i store træk holde fri Iuftvejspassage gennem nasopharynx, oropharynx og hypopharynx, med fravær af okklusion af disse.

2. En trinløs anti-snorke og søvnapnø forhindrende mandibei fremførende anordning (2) der består af en øvre del, beregnet bl omfavnelse af det humane maksiliære tandsæt, og en nedre dei, beregnet tii omfavnelse af det humane mandibuiære tandsæt, karakteriseret ved at den øvre og den nedre del er resilient eller mekanisk hængslet i forhold til hinanden i den mest posteriore del af anordningen, og hvor de enkelte dele (maksiiære og mandibuiære) er trinløst forskydelige i forhold tii hinanden ved hjæip af trinløse mekanismer indiejret søm integrerede dele af den ene part(mandibular-delen), og hvor det posteriore hængselied er adapteret hf at følge de fysiologiske bevægelser af underkæben (mandibula) I det sagittate plan, samtidig med at holde en fremskudt position af underkæben i forhold til overkæben (maksilia), og derved i store træk holde fri iuftvejspassage gennem nasopharynx, oropharynx og hypopharynx, med fravær af okklusion af disse.

3. En trinløs anti-snorke og søvnapnø forhindrende mandibei fremførende anordning (3) der består af en øvre dei, beregnet til omfavnelse af det humane maksiliære tandsæt, og en nedre del, beregnet hl omfavnelse af det humane mandibuiære tandsæt, karakteriseret ved at den øvre og den nedre del er resilient eller mekanisk hængslet I forhold til hinanden i den mest posteriore de! af anordningen, og hvor de enkelte dele (maksiiære og mandibuiære) er trinløst forskydelige i forhold til hinanden ved hjæip af trinløse mekanismer indiejret som integrerede dele af den ene dei (maxiliar-deien), og hvor det posteriore hængselied er adapteret hl at følge de fysiologiske bevægelser af underkæben (mandibula) i det sagitaie pian, samtidigt med at holde en fremskudt position af underkæben i [^0)(^992 overkæben (maksiiia), og derved i store træk hoide fri luftvejspassage gennem nasopharynx, oropharynx og hypopharynx, med fravær af okkiusion af disse.

4. En anordning i henhold til ethvert af foranstående krav 1-3, hvor den trinløse mekanisme udgøres øf sammensatte strukturer som kroge og løkker, som i Velcro, hvor den ene part, for eksempel den mandibulære part består af kroge og den modstående part, for eksempel den maksiiære part består af løkker, og visa versa.

5. En anordning i henhold til krav 4 hvor krogene og løkkerne er mikroskopiske, mesoskopiske eller makroskopiske i størrelse.

6. En anordning i henhoid til krav 4 og 5, hvor krogene og løkkerne er lavet af et andet ikke toksisk materaie, der er forskelligt fra det materiale de maksiiære og mandibulære parter, til omfavnelse af det humane tandsæt, er Savet af.

7. En anordning i henhold til ethvert af de foranstående krav 1-6 hvor den trinløse mekanisme kan fjernes fra basis af de enkelte parter (maksiiære, mandibulære og hængslet), fornyes, repareres og remonteres til de enkelte parter igen.

8. En anordning i henhold til kravene 1-3 hvor den trinløse mekanisme består af et teleskopisk system, hvor den ene part er udformet som en cylinder og den anden part er udformet som et stempel.

9. En anordning i henhoid til ethvert af kravene 1-3 og 8, hvor udformningen af den trinløse teleskopiske mekanisme adskiller sig fra den cirkulære form, for eksempel, rektangulær, svalehale osv.

10. En anordning i henhold ti! krav 8 hvor cylinderen og stemplet er udformet i et andet ikke toksisk materiale, der adskiller sig fra det materiale den maksiiære og den mandibulære part til omfavnelse af det humane tandsæt, er fremstillet af. IL En anordning i henhold ti! ethvert af foranstående krav 1-10 hvor den øvre part har en anterior væg til adaptation af de faciale flader af fortænder, hjørnetænder og præmolarer i overkæben, samtidigt med fravær af en paiatinal væg til adaptation for de palatinale flader af samme tænder, og den nedre part har en posterior væg dl adaptation med de llnguale flader af fortænder, hjørnetænder og præmolarer i underkæben, med samtidigt fravær af en facial flade ti! adaptation for de fasiale flader af underkæbe tænderne.

12. En anordning I henhoid til ethvert af de foranstående krav hvor den øvre og den nedre part er fremstillet i et thermoplastisk materiale, der foretrækkes

13. En anordning i henhold til ethvert af kravene 1-6 hvor den øvre og den nedre part er integreret gennem et resilient hængselied fremstjjj^a^j samme materiale som den øvre og nedre part.

14. En anordning i henhold til ethvert af kravene 1-6 hvor hængselledet er lokaliseret i den mest dorsale del af anordningen integreret i eller resilient på grund af materialet i sig selv.

15. En anordning i henhold til kravene 13 og 14 hvor den mest dorsale part al ledet er konveks i den mest posteriore del og konkav i den mest anteriore del af ledet, når anordningen er placeret i patients mund.

16. Et sæt bestående af anordningen I henhold ti! ethvert af foranstående krav, sammen med en temperaturindikator, konstrueret til at vise temperaturforandringen ved den temperatur materialet kan tilpasses den enkelte patients individuelle tandsæt.

17. Et sæt i henhold til krav 16 med en opvarmelig metatplnd med isoleret håndtag til brug for fiksering af den glidende trinløse proces, ved at penetrere begge parter på det ønskede niveau af fremføring af underkæben i forhold tii overkæben.

18. En metode tii fremstilling af trinløse mandibeifremførende anordninger i henhold tt ethvert af kravene 1-15,