WO2010007201A1

WO2010007201A1 - Improved mandibular advancement device

Info

Publication number: WO2010007201A1
Application number: PCT/ES2009/070292
Authority: WO
Inventors: Felix De Carlos Villafranca; Angel Fernandez-peña Artime; Covadonga Alvarez Abad; Libia Lopez Iglesias; Maria Pilar Fernandez Mondragon; Aranzazu Senosiain Oroquieta; Angela Garcia Suarez; Juan M. Cobo Plana; Alberto Alvarez Suarez; Berta Pardo Lopez; Belen Diaz Esnal; Emilio Macias Escalada; Teresa Cobo Diaz; Juan Jose Garcia Fernandez
Original assignee: Felix De Carlos Villafranca; Fernandez-Pena Artime Angel; Covadonga Alvarez Abad; Libia Lopez Iglesias; Fernandez Mondragon Maria Pila; Aranzazu Senosiain Oroquieta; Angela Garcia Suarez; Cobo Plana Juan M; Alberto Alvarez Suarez; Berta Pardo Lopez; Belen Diaz Esnal; Emilio Macias Escalada; Teresa Cobo Diaz; Juan Jose Garcia Fernandez
Priority date: 2008-07-17
Filing date: 2009-07-16
Publication date: 2010-01-21
Also published as: ES1069826Y; KR20110033840A; FR2933861A3; PT10448T; FR2933861B3; CZ201119A3; DE112009001742T5; ES1069826U

Abstract

The invention relates to a mandibular advancement device for use in the intraoral treatment of problems involving obstruction of the upper airway, which device is fitted and adapted to the upper and lower teeth so as to maintain same interlinked with a sufficient advancement and opening to enable breathing and to leave the airway unobstructed. The advancement distance between the lower jaw bone and teeth and the upper jaw bone can be altered progressively, enabling effective but limited mobility through the use of a set of interlinked parts cast in occlusal splints, which can be used to adjust the position between the two opposing jaw bones with the simple incorporation of an interchangeable connecting part having different advancement measurements in the intermediate zone thereof, said part including two upper and lower flanges which are in turn inserted into recesses for stabilisation using set screws.

Description

IMPROVED MANDIBULAR ADVANCE DEVICE

DESCRIPTION

OBJECT OF THE INVENTION

The object of the present invention is an improved mandibular advancement device, adjustable and adaptable to the upper and lower dentures, keeping them connected with a sufficient opening for a smooth and comfortable breathing, forcing the lower jaw to advance with its denture with respect to the upper one, but allowing virtually natural mobility in every way, but limited. The mandibular advancement devices are introduced into the mouth and modify the position of the jaw, tongue, and other support structures of the Upper Airway (VAS) for the treatment of snoring and / or Sleep Apnea-Hypopnea Syndrome (SAHS), are devices used in the dental, stomatological and orthodontic medical field, the main objective being to advance or advance the lower jaw with respect to the upper jaw, in order to keep the airway permeable or released to a sufficient degree, in such a way that it largely avoids its fortuitous or unconscious closure.

The present invention characterizes the special configuration and design of a device that coupled in the dental arches, advances or advances the jaw, separates the jaws from each other, and allows us to perform a series of very wide movements controlled or limited by the device. Incorporating an interchangeable piece that will be replaced periodically by a similar piece of different size, according to the appropriate medical treatment, achieving the necessary progress to achieve the final goal of the treatment.

REPLACEMENT SHEET (Rule 26) Thanks to the use of the device object of the invention it is possible to achieve the displacement of the jaw in a progressive, little traumatic, and comfortable way. Allowing us a good jaw mobility with respect to the devices that are currently known for this same purpose.

Therefore, the present invention is mainly circumscribed, within the medical field of orthodontics.

BACKGROUND OF THE INVENTION

The use of intraoral devices in the treatment of obstructive problems of the "Superior Airway (VAS)" is not a new concept. Already in 1902, Pierre Robin advocated the use of an apparatus of these same characteristics (monobloc) in order to perform a functional mandibular overtaking, leading the latter to a more advanced position. With this, an additional drag of the tongue was achieved and the backward lingual fall (glossoptosis) that appeared during the supine position in children with mandibular hypoplasia was avoided. The first publications of intraoral appliances in relation to "Sleep Apnea-Hypopnea Syndrome (SAHS)" appear in the eighties of last century, as an attempt to seek alternative treatments, both surgical procedures and at continuous positive pressure in the upper airway. Although more than 50 types of effective devices for the treatment of snoring have been described in the market, the mandibular advancement devices in their two versions (fixed advance and adjustable advance) are the really effective ones in the management of obstructive road problems upper aerial

REPLACEMENT SHEET (Rule 26) The mandibular advancement devices perform an anterior and inferior movement of the jaw, generating anatomic variations in the upper airway that increase the pharyngeal sectional area. This movement stabilizes and fixes the jaw and the hyoid bone, which prevents the post-rotation of these structures during the recumbency and prevents the occupation of the airway. It has been proven that in individuals (SAHS) the total percentage of time in which patients sleep with their mouths open more than 5 mm. (posterior rotation and retrusion) is significantly higher (69.3%) than in healthy individuals (11.1%); therefore, the movement of rotation and fixation of the jaw during sleep can be one of the important elements during treatment with the mandibular advancement devices.

Although their greatest effect when using these devices, appears in the velopharyngeal area, they also have repercussions in all pharyngeal segments. Initially there is an increase in stiffness and a widening of the space between the anterior and posterior pillars of the pharynx.

It has been electromyographically verified how the tone of the lingual musculature (especially the genioglossus) is increased after using these devices and how it descends again after removing the device. The tongue moves forward and occupies a superior position, thus hindering its broth back during sleep. These devices perform a function similar to that which occurs during conscious sedation, and cardiopulmonary resuscitation maneuvers in which after ensuring and preserving the permeability of the upper airway, releasing it from any foreign object, an anterior traction maneuver is performed and lower

REPLACEMENT SHEET (Rule 26) mandibular Said mandibular functional advance induces changes in the position of the hyoid bone towards a more advanced position. A new equilibrium situation of the suprahyoid musculature appears now, which favors the increase in volume and the permeability of the upper airway.

Although the response to the use of these mandibular advancement devices is not the same in all patients, many experts admit that there is a dose-dependent effect, since increasing the degree of mandibular advancement improves the patient's clinical situation. Thus, as we increase the protrusion, an improvement appears both in the number and severity of desaturations. In the same way, a better response to the use of these devices has been associated, in patients with low body mass index, reduced neck circumference, young patients, low basal apnea-hypopnea index (AHI) and in apneic episodes associated with the supine position.

Although initially the design of the device used did not seem to be related to its effectiveness, it has recently been described that even the percentage of successes can be improved with the use of devices with adjustable advance, which concludes that the more aggressive the protocols, the greater the success ratio.

These devices are very effective in the treatment of snoring with a 50% elimination of cases, and achieve a significant reduction in 90/100% of patients, as well as an improvement in sleep quality.

The manufacture of the device is only the first link in the treatment. These must be accommodated according to protocols to achieve optimal results, both

REPLACEMENT SHEET (Rule 26) efficiency as comfort for users.

Once the device has been performed and adjusted, the patient is trained for insertion and maintenance care. After getting the patient accustomed to the device, progress is gradually made.

(usually requires weeks or months of adjustment) until a comfortable and adequate position is achieved to relieve snoring and / or sleep apnea.

Treatment with these devices is a reasonable alternative, since they do not involve a permanent change in individuals (as is the case with surgery) and can be dismissed at any time. The appropriate study of the patient in terms of risk / benefit assessment must be presented individually in order to achieve the best therapy in each case.

Therefore, it is the objective of the present invention to improve the existing devices today, performing them in a less sophisticated, more practical and easy to use, more comfortable, and economical way.

DESCRIPTION OF THE INVENTION

The present invention of an improved mandibular advancement device basically consists of a set of pieces that are arranged inside the mouth, adjusted in the corresponding denture, which will allow us to advance the lower jaw with respect to the upper one, but in a progressive way, by being able to replace periodically, according to medical treatment, the main link piece (1) that will modify its progress.

As already explained, the fact of advancing the lower jaw causes the upper airway to be released.

The set of the device that attaches to the denture is constituted by five pieces fundamentally, a top splint of material

REPLACEMENT SHEET (Rule 26) plastic (6) and a lower one, which incorporates frontally inside metal pockets (3), which will be linked by an interchangeable feed piece (1) of different frontal dimensions, and fixed to the pocket (3) by means of captive screws (8), which will allow us to easily and periodically exchange the pieces (1), placing each one with a larger advance in its area (13).

Therefore, with the device object of the present invention it is possible to carry out a simple and correct treatment of progressive mandibular advancement of a patient, achieving a precise advancement of the jaw, which achieves the desired therapeutic objectives.

ADVANTAGES OF THE INVENTION

The main advantages of the present invention are the following:

The present device allows us a very simple and comfortable adaptation to the denture.

The number of pieces used are minimal and easy to manufacture.

Its set is firm and stable, in the same way that will allow us to perform practically all necessary, but limited movements.

The user will quickly get used to using it.

The use of the device during treatment is simple, convenient, and fast. - Its manufacture and assembly is economical and simple.

DESCRIPTION OF THE DRAWINGS

To complement the description that will then be made and in order to help a better understanding of

REPLACEMENT SHEET (Rule 26) Its characteristics are accompanied by the present specification, of a set of drawings in whose figures, in an illustrative and non-limiting manner, the most significant details of the invention are represented.

Figure 1 ^a Shows a partial lateral section made by the center of a person's head; it highlights the airways, from the trachea (17), to the nasal cavity (20) and the mouth (10). It clearly depicts the upper (12) and lower (11) jaws, among which is the tongue (14). We also indicate with "A" the direction of the movement that we intend to make in order to release the area of the larynx "X".

Figure 2 ^a Shows a partial partial section made by the center of a person's head; it highlights the airways actively with arrows that communicate at the height of the pharynx (16), from the trachea (17), to the nasal cavity (20) and the mouth (10). It clearly depicts the upper (12) and lower (11) jaws, among which is the tongue (14). We also note with ^W A "movement direction we have made the lower jaw (11) releasing the area of the ^{larynx> Λ} Z". This movement is what we will be able to perform with the use of the mandibular advancement device that is being described.

This figure indicates a circle of detail that will be expanded in Figure 3 ^a in which we will incorporate the device.

Figure 3 ^a Shows a detailed and enlarged section of the area indicated in Figure 2 ^a , with the mandibular advancement device incorporated into the denture (9) of the patient's mouth (10).

Figure 4 ^a Shows a partial partial section made by the center of the device, clearly representing as

REPLACEMENT SHEET (Rule 26) It is the assembly of it. We have occlusal splints

(6) made in a traditional way, which is incorporated frontally when they are made, facing each other by its opening of the interior (4) some pockets (3) where parts (1) that incorporate an intermediate zone will be inserted (13) that will generate the advance of the device, being able to be interchangeable to place pieces (1) of different sizes, being tied to the pockets (3) by means of captive screws (8), when crossing the windows (2) of the body (one) .

Figure 5 ^a Shows two lower plan views of the two splints (6) that have to face to get the device, before linking with the piece (1). Each of them will adapt perfectly to the upper and lower dentures. These are made by removing a mold from the patient's complete denture in the traditional way, and when melting the piece to make the splint, the pockets (3) are incorporated frontally, being perfectly covered by the plastic material of the splint.

Figure 6 ^a Shows a somewhat schematic front view of the device, indicating how the splint (6) is assembled frontally with the built-in pockets (3), with the pieces (1) in the form of eight centrally located, and with the screws (8) tied in the pockets (3).

Figure 7 ^a Shows two front views of the body (1) interchangeable in the form of eight. This incorporates two windows (2) for its mooring in the pockets (3) by means of the screws (8). It also shows a central area (13) of variable dimension, which can then incorporate a staggering of different measures as you can see in figure 8 ^a to increase the progressive advance of the device.

Figure 8 ^a Shows the profile body (1) in different sizes according to the size or advance of the zone (13), which will be

REPLACEMENT SHEET (Rule 26) exchanging according to the treatment.

Figure 9 ^a Shows a perspective of the body (1) with its windows (2) and advance zone (13).

Figure 10 ^a Shows three views of the pockets that are to be placed in front of the splints (6) and that will be cast together, with its interior (4) for insertion of the piece (1) and with the holes (15) for the placement of the captive screw (8) •

Figure 11 ^a Shows a semi-sectioned view on the lower floor of how the part (1) is inserted inside the pocket (3) a moment before the screw (8) is introduced for fixing.

Figure 12 ^a Shows a semi-sectioned view on the lower floor of how the piece (1) is placed inside (4) of the pocket (3) once the screw (8) has been inserted fixing the device for use.

Figure 13 ^a Shows a schematic front view of the device at rest indicating possible movements that can be performed with the use of this device once incorporated into the patient's denture, vertical movement (BB) and horizontal movement (CC). 14, the 15 and 16 ^to movement once performed is shown.

Figure 14 ^a Shows a front schematic view indicating the vertical movement (BB) in its maximum closing position. We see how the cashier (3) limits the movement internally.

Figure 15 ^a Shows a front schematic view indicating the vertical movement (BB) in its maximum opening position. We see how the screw (8) located in the pocket (3) limits the opening movement.

REPLACEMENT SHEET (Rule 26) Figure 16 shows a schematic front view showing the movement performed horizontally (CC) in place of lateral displacement. We see how the screw (8) located in the pocket (3) allows to act in this movement.

Figure 17 ^a Shows a schematic front view where it can be seen that the device also allows us to perform laterally decompensated balancing movements (DD), thanks to the arrangement between the pockets (3) and the parts (1) controlled by the screws ( 8).

DESCRIPTION OF THE DIFFERENT ELEMENTS REPRESENTED IN THE DRAWINGS OF THE INVENTION

1 - Main body of the device, is the interchangeable piece or (advance piece) that will mark the progress made. This piece can be flat or incorporate a stepping (13) of the precise measurement. In Figure 9 ^a we see a perspective of it, and in Figure 8 ^a several pieces are shown with steps of different measures, which will mark the advance. The body has two windows (2) that will be used for fixing inside (4) of the pockets (3) by means of captive screws (8).

2 - Windows that presents the body (1) and that will be used for fixing inside (4) of the pockets

(3) by means of captive screws (8).

3 - Pockets placed at each end of the body (1), where they will be thanks to the screw (8).

4 - Interior space of the pockets (3) where the ends of the body (1) will be inserted.

5 - Plastic envelope layer of the pocket (3), attached to the

REPLACEMENT SHEET (Rule 26) occlusal splint (6).

6 - Upper and lower occlusal splints of custom plastic material, which adapt to the upper and lower dentures (9). Said splints incorporate the pockets (3) frontally being molten and plastic coated next to them.

7 - Inside the splints (6) where the patient's denture is housed.

8 - Body fixing screws (1) inside the pockets (3).

9 - Patient's denture to be inserted into the splint (6).

10-Patient's mouth where the device is to be inserted.

11 - Lower jaw, which we intend to advance according to (A), with respect to the upper jaw (12).

12 - Upper jaw.

13 - Intermediate area of the body (1) which will create the progressive advance of the device when the pieces are exchanged

(1), using pieces of different sizes, as we see in Figure 8 ^a .

14 - Patient's language.

15 - Threaded holes of the pocket (3) for the insertion and fastening of the captive screw (8).

16 - Pharynx of the patient. Communication point between the nasal and the oral cavity, which we intend to keep released.

17 - Trachea of the patient (airway).

REPLACEMENT SHEET (Rule 26) 18 - Esophagus of the patient (food route).

19 - Epiglottis of the patient. Located on the back of the tongue (14) that acts as a valve or lid of the trachea (17) and can close the airway in the area (X) of the larynx.

20 - The patient's nasal cavity, which communicates with the oral cavity, and the trachea (17).

X - Area of the larynx that is intended to be cleared or released, as we see in Figure I ^a .

Z - Area of the larynx once released or permeable, as we see in Figure 2 ^a

This description does not become more extensive, in the good understanding that any expert in this field would have enough information to understand the scope of the invention and its derived advantages, as well as to proceed to reproduce it.

The invention, within its essentiality, can be put into practice in other embodiments that differ in detail from that indicated by way of example of the description, and to which it will also achieve the protection sought. Likewise, it may be constructed in any shape and size with the most suitable materials, since all of this is included in the spirit of the claims. The terms in which this report has been described must always be taken in a broad and non-limiting sense.

REPLACEMENT SHEET (Rule 26)

Claims

1.- Improved mandibular advancement device, of the type used for intraoral treatment on problems of obstruction of the upper airway characterized by being a set of parts linked together, and can be adapted to the upper and lower dentures, which will allow us to adjust the positioning between the upper and lower jaw with a simple replacement of an interchangeable piece (1) that may have different dimensions in the area (13), a piece consisting of two upper and lower windows (2), which in turn they are inserted into the inside (4) of the pockets (3) for fixing with a captive screw (8), which in turn are molten forming a unit with the occlusal splints (6) that will finally remain for use together with the upper denture and another with the lower one, all this allowing the joint to perform mandibular movements according to (BB) - (CC) - (DD), and others that combine them with each other.

REPLACEMENT SHEET (Rule 26)