DE102009048376B3 - Two-parted and bimaxillary snoring and apnea orthesis i.e. intraoral protrusion orthesis, for treating snoring and obstructive sleep apnea, has upper jaw rail connected together with lower jaw rail by connection rods or joint rods - Google Patents

Abstract

The orthesis has an upper jaw rail (1) running in an occlusal region, a lingual region and/or palatinal region, a buccal region and front tooth region of a front tooth. The upper jaw rail is connected together with a lower jaw rail (2) by connection rods or joint rods (3) e.g. metal rods, which are fixed at a metal frame by screws on threaded sleeves (4, 5). The connection rods consist of stainless steel alloys and comprise length between 18 mm and 28 mm. The lower jaw rail consists of soft plastic and/or hard plastic, e.g. polymer and monomer.

Description

Technical area

The The present invention relates to a two-part and bimaxillary snoring device. and apnea splint (hereinafter also referred to as intraoral splint splint) for the treatment of snoring and / or obstructive sleep apnea (nocturnal respiratory arrest).

State of the art

The Obstructive Sleep Apnea Syndrome (OSAS) is regularly followed by Snoring and respiratory arrest (Apnoes) during of sleep and clinically primarily due to a pronounced daytime fatigue to the point of falling asleep (microsleep) and a number of others Symptoms and sequelae (eg hypertension) are indicated. In the apnea there is generally a blockage (obstruction) of the upper one Respiratory system before, usually oscillates in addition the soft tissue (soft palate, etc.) due to the muscular relaxation of the body in the sleep flapping in the suction of the breath, what to the snoring as known noises to lead can.

Snore and Apnoeschienen are known in the prior art already in different embodiments. These are removable dental splints made of plastic, which resemble orthodontic appliances or so-called crunchy bars. They are more correctly referred to as intraoral protrusion splints or mandibular protrusion splints, which are only worn during sleep in the mouth and affect the mandibular position, the tongue position and other soft parts and hold them in a forward position (= protrusion) US5462066A and EP1203570B1 ). As a result, a falling back of the lower jaw and the attached soft parts is prevented in particular when the patient is supine. This results in an enlargement of the pharynx with a free airway during sleep and a healthy nocturnal breathing without respiratory failure and without snoring.

Current The following mandibular protrusion splints are used for dental care Treatment of snoring and sleep apnea classified: By number the components: one-piece or two-piece rails. After Type of attachment to the jaw: unimaxillary (fixation only in the lower jaw) or bimaxillary (Attachment in the lower jaw and upper jaw). Thus, there are z. B. the constellation of a one-piece and unimaxillary or that of a two-piece and bimaxillary protrusion splint.

From the pamphlets DE 102 162 42 C1 and DE 20 2008 016 373 U1 are two-part, bimaxillary snoring and apnea, especially for the treatment of snoring and / or obstructive sleep apnea known by advancement of the lower jaw. These have a maxillary splint and a lower jaw splint, which are connected on both sides via hingedly arranged on the rails secondary extending ironing / Vorschubstäbe (outside of the rows of teeth), wherein in DE 20 2008 016 373 U1 each feed rod is hinged at one end to the upper jaw splint and at the other end to the lower jaw splint, so that when the splint is in a mouth, the lower jaw of a user is pushed forward relative to the upper jaw.

The Raw devices come from the year 1982 (Esmarch orthosis after Meier-Ewert), the at that time a one-piece monoblock, both jaws fixed encompassed and fixed, leaving no free mandibular mobility was given. Newer rails and currently dominating are two-piece and bimaxillary Mandibular advancement. Latest developments are moving towards one-piece and unimaxillary splint (SchäfLa) the better in normal and head bite are suitable because the vertical bite blocking in these cases lower is as in bipartite and bimaxillary protrusion splints. Under the two-part and bimaxillary So far, there is only one type of rail, the H-UPS, which is through a frontal open design of the rail body a maximum reduced vertical bite opening enable tooth contact in the front with cutting edge. The anterior regions are in the sense of being "open".

The Connection is z. For example, in the already patented H-UPS with two Metal connectors accomplished. In contrast, all other two-piece rails the fundamental Characteristic that the plastic body is continuous on the respective pines rests and "frontal closed "are. The decisive advantage of the frontal open, two-piece protrusion splints is that in the so-called deep bite through the avoidance of this frontal plastic portion the so-called. Vertical Bisssperrung can be massively reduced, what the so-called compliance (= Acceptance of the splint by the patient) is significantly improved.

All Two-piece rails are characterized by very diverse technical Additional elements (detachable) connected together and secure in this way the lower jaw performance. The main advantage of these protrusive holding elements on snoring and apnea two-piece protrusion splints is that a direct change the protrusive position of the lower jaw or a stepwise gradual Forward displacement of the lower jaw (= titration) is possible.

at one-piece rails, such. B. the SchäfLa rail, is by a on the rail body integrated holding plate, which is fixed on the lower jaw, which rests on the upper jaw, prevents the lower jaw from sleeping and especially in supine position fall behind the patient can.

in the Difference to one-piece rails have all two-piece and bimaxillary Protrusion rails have the disadvantage that with the requirement of this special technical Protrusionshalteelemente the cost is larger. Furthermore is naturally the attachment (= Retention) in both jaws required; the so-called retention requirement So it's bigger.

Of the most serious difference between "frontal open" and "frontal closed two-part and bimaxillary rails is that with "frontal open "rails a small so-called vertical bite blocking can be reached between upper and lower jaw. This is for the track selection also for compliance in individual cases is crucial. The vertical bite blocking in the distal, ie posterior posterior region at "frontal closed "rails can 8-9 mm and more. At "frontal open "design This bite block can be limited to about 4 mm, as a result the lack of frontal plastic share a direct incisor contact is reachable. This is especially the so-called. Deep bite regularly the Case.

Frontal closed two-piece protrusion splints generally have one too big vertical bite blockage, partly also technically, d. h., due to the track is. This has significant negative consequences for the burden of the chewing organ in continuous use, causes more unwanted side effects and is with a reduced compliance (acceptance by the patient) connected.

With The H-UPS was trying to frontal this cardinal disadvantage avoid open rail design. But since it only has an outer metal connector is provided between the respective rail halves goes at the expense of stability The rail itself is also involved in H-UPS cases an unfavorable one Tooth form thereby insufficient, because the rail support alone by the posterior teeth must be provided alone for the rail friction available stand.

Presentation of the invention

Of the The object of the present invention is to provide a snore and Apnoeschiene to create the protrusive position assurance of the mandible during sleep and especially in supine position of the patient the treatment of obstructive sleep apnea syndrome (OSAS), a widespread disease with a frequency from 2-4% the population. This is to avoid blockages (obstructions) in the middle pharynx or repealed that for respiratory air volume increased / normalized and respiratory Values of the sleep apnea in principle and be permanently improved.

According to the invention solved above object with the features of claim 1. advantageous Embodiments of the snore and Apnoeschiene invention are in dependent claims specified.

The present invention is a novel bipartite, bimaxillary, and frontal open protrusion splint, hereinafter referred to as "BußLa". The BußLa is only comparable with a single, already known and patented protrusion splint, with the H-UPS. Both, H-UPS and BußLa, are two-part, bimaxillary, frontal open and the plastic rail body of both rails ( 1 . 2 ) detects on its underside the teeth (periodontia = periodontium) of both jaws.

The teeth of both jaws are at the BußLa by the removable rail body ( 1 . 2 ) in the posterior region. The lower jaw is placed in a protrusion. Metallic connecting bridges ( 3 ) provide for the coupling of both rails and ensure this protrusive position of the lower jaw. The lower jaw still remains largely free to move.

in the Unlike the H-UPS, the BußLa is a construction has the following novelties and developments.

• 1: die Kraftverteilung auch tatsächlich auf allen Parodontien gleichmäßig verteilt wird und die Überlastung einzelner Zähne dadurch ausgeschlossen wird,
• 2: der wichtigste Nebenwirkung von Protrusionsschienen (Zahnbewegungen und Zahnstellungsänderungen infolge der Kraftübertragung) auf diese Weise entscheidend entgegen gewirkt wird,
• 3: die Akzeptanz der Schienen insgesamt auch durch die unauffällige, innenseitige Anbringung der Verbinder und speziell durch die deutlich reduzierte vertikale Bißsperrung entscheidend verbessert wird,
• 4: die Akzeptanz der Schiene durch den Patienten durch die vergleichsweise zu anderen zweiteiligen Schienen sehr grazile Bauweise deutlich besser wird.

The connection of the respective rail halves is made by an extremely stable metal framework in the upper jaw ( 8th ) and in the lower jaw ( 9 ). Frontal these metal connectors are not - as with the H-UPS - mounted on the tooth outside, but on the inside of the tooth. This increase in stability ensures that:

• 1: the force distribution is actually distributed evenly on all periodontal areas and the overload of individual teeth is thereby excluded
• 2: the most important side effect of protrusion splints (tooth movements and tooth position changes due to the transmission of force) is decisively counteracted in this way,
• 3: the acceptance of the rails is also significantly improved by the inconspicuous, inside attachment of the connectors and especially by the significantly reduced vertical bite blocking,
• 4: the acceptance of the splint by the patient by the comparatively to other two-piece rails very graceful construction is significantly better.

Advantages of the invention

• – geringste praktisch mögliche vertikale Bißsperrung mit 0 mm in der Frontzahnregion (direkter Schneidzahnkontakt),
• – höchste mechanische Stabilität durch integrierte Metallgerüste (8, 9),
• – beste Compliance (Akzeptanz) und Langzeitnutzbarkeit durch insgesamt grazile Gestaltung und infolge dieser geringen vertikalen Bißsperrung,
• – geringste Nebenwirkungsrate insbesondere durch die direkte Anlage der Metallgerüste 8, 9 an der Innenflächen der Zähne und durch die Verblockung der beiden Kiefer-/Schienenhälften bzw. der Zähne. Insbesondere den ungewollten Zahnbewegungen durch die Krafteinleitung wird erfolgreich entgegen gewirkt.

The BußLa has the following advantages for all two-part and bimaxillary protrusion splints in general and for H-UPS in particular:

• - lowest possible vertical bite blockage with 0 mm in the anterior region (direct cutting tooth contact),
• - highest mechanical stability thanks to integrated metal frameworks ( 8th . 9 )
• - Best compliance (acceptance) and long-term usability due to overall graceful design and as a result of this low vertical bite blocking,
• - lowest rate of side effects, in particular by the direct installation of the metal frameworks 8th . 9 on the inner surfaces of the teeth and by the blocking of the two jaw / rail halves or the teeth. In particular, the unwanted tooth movements caused by the introduction of force is successfully counteracted.

Description of the production

High precision superharpple models (upper jaw 6 , Lower jaw 7 ) are made individually by the dentist after the dentist's silicone teeth have been molded. The ground plaster models are brought into the required position and fixed to one another after a protrusion bite taken by the dentist in a joint simulator (= articulator). The rows of teeth and teeth are measured in a so-called. Parallelometer and so set the so-called. Zahnäquator and marked. Beneath this equator undercutting areas are blocked with wax. The areas that later connect the plastic to the metal retainers are also blocked out. The plaster models 6 . 7 are doubled in a silicone mold and poured out in a refractory mass (so-called investment material). From these models 6 . 7 waxes the shape of the later metal frameworks 8th . 9 modeled. An embedding is also made of refractory mass on this model. By a customary in dental technology casting process, the metal frameworks 8th . 9 transferred to a steel alloy. In the areas Oberkiefereckzähne and lower molars are the threaded sleeves (maxillary threaded sleeve 4 , Lower jaw threaded sleeve 5 ) soldered, with which later the connecting rods 3 - also individually cast from a steel alloy - are fastened by means of screws. The retention part of the teeth encloses the metal construction from the lateral incisor to the last molars in a plastic transparent or colored by means of polymerization in a pressure pot. A high-gloss polish of all materials and a smooth adaptation of all chewing surfaces to each other ensures a perfect function of the intraoral protrusion splint.

Brief description of the drawings

Further Goals, benefits and applications the snore and Apnoeschiene arise from the following description of a embodiment based on the drawing.

1 the penitentiary opened in the top view;

2 the Bussla opened in the side view on the left;

3 the Bussla opened in the side view on the right;

4 various views of the connecting bridge.

Embodiment of the invention

• – einem Metallgrundgerüst 8, 9: frontal freiliegender Teil des Metallgrundgerüstes) und (seitlich jeweils im Kunststoff eingebetteter Teil des Metallgrundgerüstes),
• – einem ummantelnden Schienenkorpus im Oberkiefer 1 und dem Unterkiefer 2 beidseits angebrachten Gewindehülsen 4, 5 für die Verbindungsstege 3.

1 shows the Schnarch- and Apnoeschiene invention, the BußLa opened in plan view, consisting of

• - a metal framework 8th . 9 : frontally exposed part of the metal skeleton) and (part of the metal skeleton embedded in the plastic at the side),
• - A sheathing rail body in the upper jaw 1 and the lower jaw 2 both sides attached threaded sleeves 4 . 5 for the connecting bridges 3 ,

2 shows next to the sheathing rail bodies (upper jaw rail body 1 Maxillary rail body 2 ) and on the means of screws 10 . 11 on the sleeves 4 . 5 Left-sided connecting bridge 3 , On models in the upper jaw 6 and lower jaw 7 became the rail body 1 . 2 placed.

3 shows the snore and Apnoeschiene invention analog 2 only on the right and in the same numeric inscription.

4 shows different perspectives of the connecting bridge, since this is angled, ie twisted, is. The bridges 3 be with screws 10 . 11 on the threaded sleeves 4 . 5 screwed and fixed.

The BußLa is a construction, the following technical and construction-related innovations and developments having.

• 1: die Kraftverteilung auf tatsächlich auf allen Parodontien gleichmäßig verteilt wird, da der Seitenzahnbereich vom jeweiligen Schienenkorpus 1, 2 aus Kunststoff und die Frontzahnbereiche direkt durch das die auf der Innenseite der Zähne anliegende Metallgerüste 8, 9 erfasst und verblockt werden. Diese Verbindung zwischen beiden Schienenkörpern 1, 2 im Oberkiefer 6 und Unterkiefer 7 liegt im Gegensatz zur H-UPS also direkt und körperlich auf den Innenseiten der Frontzähne an und dient nicht allein der Verbindung der jeweiligen Schienenhälften sondern auch der optimalen Kraftverteilung und – übertragung auf möglichst alle vorhandenen Zähnen und der Stabilisierung der Protrusionsschiene in seiner funktionellen Einheit.
• 2: der wichtigste Nebenwirkung von Protrusionsschienen (Zahnbewegungen und Zahnstellungsänderungen infolge der Kraftübertragung) auf diese Weise entscheidend entgegen gewirkt wird, da das interne Oberkiefer-Metallgrundgerüst 8 und Unterkiefer-Metallgrundgerüst 9 und der ummantelnde Kunststoff 1, 2 alle Zähne beider Kiefer umfassen und miteinander verbinden bzw. verblocken.
• 3: die Reparaturanfälligkeit infolge der Metallgrundgerüste (8, 9) durch Reduktion der Bruchgefahr massiv sinkt,
• 4: die Compliance durch die vergleichsweise zu anderen zweiteiligen Schienen sehr grazile Bauweise deutlich besser wird. Das hat seine Ursachen darin, daß die BußLa alle für eine gute Complian ce erforderlichen Charakteristik auf: für den Unterkiefer gewährleistet ist eine freie Mundöffnung und Seitwärtsbewegung, eine geringe Mundraumeinengung durch die Schiene selbst und damit durch einen hohen Tragekomfort insgesamt. Nebenwirkungen auch im Kiefergelenkbereich sind somit sehr selten, jedenfalls geringer als bei allen anderen zweiteiligen und frontal geschlossenen Protrusionsschienen mit deutlich größerer vertikaler Bisssperrung.
• 5: individuell gegossenen Verbindungsstege 3 über Schrauben 10, 11 auf den dafür vorgesehenen Gewindehülsen 4, 5 mit den Metallgrundgerüsten 8, 9 stabil verbunden werden.

The connection of the respective rail halves is made by an extremely stable metal framework 8th . 9 , Frontal this metal framework runs in physical contact with the inside of the teeth on the maxillary and mandibular teeth and is not - as with the H-UPS - on the tooth outside. This increase in stability ensures that:

• 1: the force distribution is actually distributed evenly on all periodontal, as the posterior region of the respective rail body 1 . 2 made of plastic and the anterior regions directly through the metal scaffolding resting on the inside of the teeth 8th . 9 be detected and blocked. This connection between two rail bodies 1 . 2 in the upper jaw 6 and lower jaw 7 In contrast to the H-UPS, it is directly and physically on the insides of the front teeth and serves not only the connection of the respective halves of the rail but also the optimal power distribution and - transmission to as many teeth as possible and the stabilization of the protrusion rail in its functional unit.
• 2: the most important side effect of protrusion splints (tooth movements and tooth position changes due to the force transmission) is counteracted in this way decisively, since the internal upper-metal framework 8th and mandibular metal framework 9 and the encasing plastic 1 . 2 cover all teeth of both jaws and connect or interlock.
• 3: the repair susceptibility due to the metal frameworks ( 8th . 9 ) decreases massively by reducing the risk of breakage,
• 4: the compliance is significantly better by the relatively delicate compared to other two-piece rails very graceful construction. This is due to the fact that the penalty for all required for a good Complian ce characteristics: for the lower jaw is guaranteed a free mouth opening and sideways movement, a small oral cavity narrowing by the rail itself and thus by a high level of comfort overall. Side effects also in the temporomandibular area are thus very rare, at least less than in all other two-part and frontally closed protrusion splints with significantly greater vertical Bisssperrung.
• 5: individually cast connecting bridges 3 about screws 10 . 11 on the provided threaded sleeves 4 . 5 with the metal frameworks 8th . 9 stable connected.

• 6: die unerwünschte und dem Therapieziel zuwider laufende Verengung im Rachenbereich durch Zurückfallen des Unterkiefers und bei Mundöffnung wird vor allem durch die grundsätzlich geänderte Anordnung der Stege 3 gewährleistet: die Stegbefestigung erfolgt im Oberkiefer mittels Schrauben 10, 11 im vorderen Zahnbereich des Oberkiefers 6 (zumeist im Eckzahnbereich) und im Unterkiefer 7 im hinteren Bereich (an den Backenzähnen). Damit wird auch in Rückenlage verhindert, daß bei Mundöffnung der Unterkieferwinkel zu einer Obstruktion führt, da konstruktionsbedingt der Unterkiefer durch die beidseits lateral angebrachten Stege 3 in diesem Fall nach vorne zieht.

A special feature in this case allows the good lateral mobility of the lower jaw in particular: the holes at the ends of the molded connecting web 3 can be designed round, but also oval. Thus, according to the individually present contact relations between the two jaws or their teeth with respect to each other, this freedom of movement can be adapted (individually) (modeled and cast). The connecting bridges 3 allow movements in all dimensions, with the exception of one exception: the Retralverlagerung the lower jaw (with narrowing of the upper respiratory tract) is invariably and reliably prevented.

• 6: the undesirable narrowing of the throat, which is contrary to the therapy goal, due to falling back of the mandible and mouth opening, is mainly due to the fundamentally changed arrangement of the bars 3 Guaranteed: the bridge attachment takes place in the upper jaw by means of screws 10 . 11 in the anterior tooth area of the upper jaw 6 (mostly in the canine area) and in the lower jaw 7 in the back area (on the molars). This prevents even in the supine position that the mandibular angle leads to obstruction in mouth opening, because of the design of the lower jaw by the laterally mounted on both sides webs 3 pulls forward in this case.

1

rail body upper jaw

2

rail body lower jaw

3

connecting web between upper jaw and lower jaw

4

Threaded sleeve upper jaw on the metal framework

5

Threaded sleeve lower jaw on the metal framework

6

Maxillary plaster model (analogous to an upper jaw)

7

Mandibular plaster model (analogous to a lower jaw)

8th

Metal framework upper jaw

9

Metal framework lower jaw

10

screw on sleeve of the metal framework in the Metal skeleton of the upper jaw

11

screw on sleeve of the metal framework in the Metal skeleton of the lower jaw

Claims (4)

Two-part and bimaxillary snoring and apnea rail for the treatment of snoring and / or obstructive sleep apnea by advancement of the lower jaw, consisting of an upper jaw splint ( 1 ) and a lower jaw splint ( 2 ), each consisting of a metal framework ( 8th . 9 ), which, when in use in the area of the molars of a user, are embedded in each case in a plastic body adapted and fixed to the molars of the user, occlusally, lingually / pa the anterior and lingual / palatal teeth of the anterior teeth, where the maxillary splint ( 1 ) with the lower jaw splint ( 2 ) via in each case at the respective metal framework ( 8th . 9 ) by means of screws ( 10 . 11 ) on designated threaded sleeves ( 4 . 5 ) fixed connecting webs or connecting rods ( 3 ) are movably connected to each other. Snore and apnea rail according to claim 1, characterized by the following features, - the webs ( 3 ) are cast metal bars; - The web joints consist of individually manufactured stainless steel alloys and have a length between 18 and 28 mm; - The holes are round or oval and are pushed over metal sleeves, locked and screwed. Snore and apnea rail after one of the previous ones Claims, characterized in that on one side angled against the dental arch Angled holes are provided. Snore and apnea rail according to one of the preceding claims, characterized in that the plastic carcasses of the upper jaw splint ( 1 ) and the lower jaw splint ( 2 ) consist of soft and / or hard plastics, which consist of polymer and monomer and are polymerized in the pressure pot and highly compressed.