ES2389407A1 - Adjustable mandibular advance device (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Adjustable mandibular advancement device, for intraoral treatment of obstruction of the upper airway, adaptable to the denture, with sufficient opening, keeping the airway released, being able to progressively alter the advance distance of the lower jaw with respect to the upper one, allowing mobility effective but limited thanks to a set of pieces linked together, cast in occlusal splints, which will allow us to adjust the positioning between the two jaws with the simple incorporation of adjustable connection pieces with a simple twist of a screw that joins two bodies similar faced and linked to create the advance in its intermediate area and incorporating two upper and lower windows, which in turn are inserted into pockets for its stabilization using a set screws, allowing the device as a whole to perform combined jaw movements variables (Machine-translation by Google Translate, not legally binding)

Description

OBJECT OF THE INVENTION

The object of the present invention is an adjustable mandibular advancement device, adjustable and adaptable to the upper and lower teeth, keeping them linked with an opening sufficient for fluid and comfortable breathing, forcing the lower jaw to advance with its teeth with respect to the upper one, but allowing practically natural mobility in every way, but limited.

Mandibular advancement devices are inserted into the mouth and modify the position of the mandible, tongue, and other supporting structures of the Upper Airway

(VAS) for the treatment of snoring and / or Sleep Apnea-Hypopnea Syndrome (SAHS), are devices used in the medical, dental, stomatological and orthodontic fields, the main objective being to advance or advance the lower jaw with respect to upper jaw, in order to keep the airway permeable or freed to a sufficient degree, in such a way that it largely avoids its accidental or unconscious closure.

The present invention is characterized by the special configuration and design of a device that, coupled in the dental arches, advances or advances the mandible, separates the jaws from each other, and allows us to carry out a series of very wide movements controlled or limited by the device. This is achieved by incorporating an interchangeable and adjustable part with a simple screw, using the appropriate size according to medical treatment.

timely, achieving the necessary progress to achieve

the ultimate goal of treatment.

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 mandibular 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 mandibular functional advance, taking the latter to a more advanced position. With this, an additional drag of the tongue was achieved and the lingual fall backwards (glosoptosis) 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 the last century, as an attempt to search for alternative treatments, both to 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 both versions (advancement

permanent

and Advance adjustable) are the Really effective in the

driving

of the problems obstructive of the tracks aerial

superior.

Mandibular advancement devices perform an anterior and inferior movement of the mandible, generating anatomical 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 lying down and avoids the occupation of the respiratory tract.

It has been verified 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 mandibular advancement devices.

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

It has been verified electromyographically how the tone of the lingual muscles (especially the genioglossus) increases after using these devices and how it decreases again after removing the device. The tongue moves forward and occupies a superior position, making it difficult to fall backwards during sleep.

These devices perform a function similar to that

This occurs during conscious sedation and cardiopulmonary resuscitation maneuvers in which, after ensuring and preserving the patency of the upper airway, freeing it from any foreign object, a mandibular anterior and inferior traction maneuver is performed. Said mandibular functional advance induces changes in the position of the hyoid bone towards a more advanced position. Now a new situation of suprahyoid musculature appears that would favor 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.

So,

according we increase the protrusion appears a

improvement

so much in the number how in the gravity of the

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 baseline apnea-hypopnea index (AHI) and in apneic episodes associated with supine position.

Although at first the design of the device used did not seem to be related to its effectiveness, recently it has been described that the success rate can even 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 an elimination in 50% of cases, and achieve a significant reduction in snoring in 90/100% of patients, as well as an improvement in the quality of sleep.

The manufacture of the device is only the first link in the treatment. These must be arranged according to protocols to achieve optimal results, both in terms of efficiency and comfort for users.

Once the device has been made and adjusted, the patient is trained for insertion and maintenance care. After getting the patient accustomed to the device, the advance begins to be carried out gradually

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

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

A mandibular advancement device is known in the state of the art, such as that described in the Spanish Utility Model, publication number ES 1069826U, which seeks to advance or advance the lower jaw with respect to the upper jaw, in order to keep the airway permeable or freed to a sufficient degree, in such a way

It largely avoids accidental or unconscious closure.

Although the objective that is sought is achieved, nevertheless the device described in ES 1069826U is capable of being improved. A drawback of the device is that the degree of mandibular advancement is fixed, and cannot be selected or regulated, which is a clear drawback in the application to patients, since not all require or can perform the same degree of mandibular advancement.

Therefore, it is an objective of the present invention to improve the currently existing devices, so that the new device allows a selection and regulation of one maxilla with respect to another, that is, that the device is not limited to a degree mandibular advancement device, developing for this purpose a mandibular advancement device such as the one described below and which is reflected in its essentiality in the first claim of the application.

DESCRIPTION OF THE INVENTION

The present invention of an adjustable mandibular advancement device, basically consists of a set of parts that arranged inside the mouth, adjusted in the corresponding denture will allow us to advance the lower jaw with respect to the upper one, but in a progressive way, by being able to incorporate , according to medical treatment, a piece of transmission of the mandibular distance that will gradually modify its advance thanks to a means of regulation of the distance that separates each of the pieces of transmission of the mandibular distance associated with each jaw.

As it has already been explained, the fact of advancing the lower jaw frees the upper airway.

The whole of the device that is attached to the denture is made up of the following parts:

a plastic upper splint and

another lower splint, where each one of them

incorporates frontally

a metal pocket, which defines a space

hollow interior in which it is housed and retained,

a transmission part of the distance or

mandibular separation, leaving the pieces of

mandibular distancing transmission

housed and retained in the cashiers linked by

guide means and coupling of some

mandibular distance regulation means.

The means of retention of the pieces of transmission of the mandibular distance in the pockets, can be any of those that a technician could think of, being one of the possible ones by means of captive screws that going from one face of the pocket to the opposite They pass through the transmission part of the mandibular distance, retaining these parts in the pockets, but not immovably, but with a certain degree of freedom.

The transmission parts of the mandibular distance have an upper housing part in the interior space of the pockets that are attached frontally to each ferrule. In addition, these pieces of transmission of the mandibular distance have a lower part, which serves for the coupling and

transmission of the guiding and distancing means

mandibular.

The upper part of the mandibular distance transmission parts have an opening through which retention means are passed so that the mandibular distance transmission parts are retained in the interior space of the pockets to a certain degree of freedom, not fixed in an immovable way.

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 mandible, which achieves the desired therapeutic objectives.

The main advantages of the present invention are the following: The present device allows us to adapt

very simple and comfortable to the teeth.

The number of pieces used are minimal and easy

manufacturing.

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

that the

The user will get used to using it.

quickly to the

Using the device during treatment it is simple, comfortable, and fast. Its manufacture and assembly is economical and simple.

DESCRIPTION OF THE DRAWINGS

To complement the description that will be made below and in order to help a better understanding of its characteristics, this descriptive report is accompanied by a set of plans in which figures, in an illustrative and non-limiting way, represent the most significant details of the invention.

Figure shows a partial side section made through the center of a person's head; it highlights the airways.

Figure 2a shows a partial lateral section made through the center of a person's head; in it I know

stand out

the tracks respiratory of shape active a time

installed

the device of Advance mandibular dimmable

object

of the invention, even if not I know he has represented, with

In order to be able to appreciate by comparison with the previous figure the modification of the airways.

Figure 3a Shows a detailed and enlarged section of the area indicated in Figure 2a, with the mandibular advancement device incorporated into the teeth of the patient's mouth.

Figure 4a shows a partial side section made through the center of the device, clearly representing how it is mounted.

Figure 5a shows two lower plan views of the two splints that must be faced to achieve the device, before linking with the transmission parts of the mandibular distance.

Figure 6a shows a schematic front view of the mandibular advancement device,

Figure 7a Shows in perspective the two transmission parts of the mandibular distance

Figure ga Shows in perspective the two pieces of transmission of the mandibular distancing linked with guides and means for regulating the mandibular distancing or separation (closed position).

Figure Shows in perspective the two transmission parts of the mandibular distancing linked by guides with a distance regulating means

(maximum open position)

Figure lOa Shows a profile view of the set of transmission parts of the mandibular distance

Figure ll Shows three views, elevation, plan and side view of a cashier to be placed in front of the corresponding splint.

Figure 12a shows a semi-sectioned view on the bottom plan of how the transmission part of the mandibular distance is inserted inside the pocket

Figure 13a shows a semi-sectioned view on the lower plan of how the transmission part of the mandibular distance is placed inside the pocket once a retaining screw has been inserted.

Figure 14a Shows a perspective of an upper splint, showing a mandibular spacing transmission piece inserted in the pocket

corresponding and stabilized with a captive screw

Figure 15a shows a side view of the entire device, prepared to be incorporated into a patient's mouth.

Figure 16a Shows a schematic front view of the device at rest indicating possible movements that can be made using this device.

device once incorporated into the patient's teeth, vertical movement (B-B) and horizontal movement

(C-C).

Figure 17a Shows a schematic front view indicating the vertical movement performed (B-B) in its maximum closed position.

Figure 18a Shows a front schematic view indicating the movement carried out vertically (B-B) in its maximum open position.

Figure 19a Shows a schematic front view indicating the movement carried out horizontally (C-C) in its

lateral displacement position. We see how the screw

(8) located in the pocket (3) allows this movement to act.

Figure 20a Shows a schematic front view where it can be seen that the device also allows us to perform laterally offset balancing movements (D-D

PREFERRED EMBODIMENT OF THE INVENTION

In view of the figures, a preferred embodiment of the proposed invention is described below.

In the figure the airways can be seen in the partial lateral section made through the center of a person's head; where they stand out from the trachea (17), the esophagus (18), the epiglottis (19), to the nasal cavity (20) and the mouth (10). They represent

clearly

the maxillary higher (12) and lower (eleven),

between

the which I know find the language (14). Too,

we point

with "TO" the direction of the movement than

we pretend

perform with the end of break free the zone of the

larynx "X".

In figure 2a, the airways can be observed actively, as a consequence of the provision of an adjustable mandibular advancement device, which has not been represented in this figure, indicating with arrows the communication at the level of the pharynx (16 ), from the trachea (17), to the nasal cavity (20) and the mouth

(10). It clearly represents the upper (12) and lower (11) jaws, between which is the tongue (14). Also, the direction of the movement we have made of the lower jaw (11) is indicated with "A", releasing the larynx area "Z". This movement is the one that we will be able to carry out 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 3a in which we will incorporate the device.

In

the figure 3rd I know shows a section detailed and

expanded

of the zone marked in the figure with the

device

of Advance mandibular incorp prayed to the teeth

(9)

of mouth (10) of the patient.

Figure 4a shows a partial lateral section made by the center of the adjustable mandibular advancement device, clearly representing how it is assembled.

It starts from occlusal splints (6) made in a traditional way, to which plastic cavities are incorporated frontally when they are made.

(

5), in which pockets are housed (3) that define an interior space in which pieces are housed and retained

(one)

transmission of mandibular distancing or separation.

Figure 5a shows two lower plan views of the two ferrules (6) that have to face each other to get the device, before linking with the parts (1). Each of them will adapt perfectly to the upper and lower teeth. These are performed by removing a mold from the patient's complete dentures in the traditional way, and when melting the piece to make the splint, plastic covers (5) are incorporated into which the pockets (3) are housed frontally, leaving perfectly covered by the plastic material of the splint (6).

Figure 6a shows a somewhat schematic front view of the device, indicating how to assemble the ferrule (6) frontally with the pockets (3) incorporated, with the pieces (1) in the form of eight centrally located, and with screws (8) fixed in the pockets

(3) •

In figure 7 a Shows in perspective the two pieces

(1) transmission of the mandibular distance, which as can be seen has a part, which we could call superior (24) in reference to the piece (1) placed on the splint of the upper jaw, and a lower part (25).

The upper part of each piece (1) of transmission of the mandibular distance has a window (2), through which the means for retaining the pieces (1) are passed into the interior space (4) of the pockets ( 3). In a possible embodiment, the retention means could be captive screws (8) that piercing the

window

(2) screw on the holes threaded (fifteen)

ready

of way faced on the walls of the

cashiers

(3).

The piece (1) of transmission of the mandibular distance, has a part that we could call

lower in relation to the piece (1) housed in the

splint

of the mandible higher. Bliss part lower (25)

count

with some media of guided and coupling of some

media

of regulation of mandibular distancing.

Said means for guiding the lower part (25) could consist of perforations or holes (21) through which guides (23) are passed, which ensure the aligned advance, without deviations of the advance transmission parts. mandibular.

The coupling means of the regulation means, in a possible embodiment, could consist of threaded perforations (22) arranged between the holes (21).

The mandibular distance regulation means, in a possible embodiment, could consist of screws (13) that thread on the coupling means, in this case, on the threaded holes (22) made in the lower part (25) of the transmission parts (1) of the mandibular distance.

Each of the screws, as shown in Figures 8 and 9, is a 50% double-threaded screw, on one left-hand threaded end, and on the other right-hand threaded end. This will be manipulated from one of its ends where it incorporates a hole to use a wrench or screwdriver adapted to the hole in question. This screw (13) together with the guides (23) will join the pieces (1) creating a step and a progressive advance of the device as we see in figures ga, 10a and 15a clearly. By turning the screw, the two pieces (1) move away or approach simultaneously, dragging the pieces (6), and the jaw (11).

In figure ga the two pieces are shown in perspective

(one)

linked already by the guides (2. 3) and the screw (13). The

two

pieces (one) I know find together assuming a

minimum distance

mandibular.

Figure ga Shows in perspective the two pieces (1) already linked by the guides (23) and the screw (13). In the figure shown, the mandibular distance is maximum.

Figure 1 O a shows a profile view of the set of parts (1), (23) and (13) joined. This set of parts will be in charge of making the appropriate and regulated advance of the device assembly by means of the screw

(13) through his head.

In figure 11a we can see in the views represented the constructive characteristics of the pockets (3), which have an open prismatic configuration on one of their faces so that access to the interior space (4) defined in the pockets is possible. Additionally, it has two threaded perforations (15) arranged facing each other and close to the opening of the pockets (13), through which the screw (8) for retaining the distance transmission parts (1) is passed mandible, particularly the upper part (24) by passing said captive screw (8) through the window (2) defined in the upper part of the pieces (1) of transmission of the mandibular distance.

Figure 12a shows how the part (1) is inserted into the interior space (4) of the pocket (3) a moment before the screw (8) is inserted to fix it.

Figure 13a shows how the part is placed

(1) inside (4) of the pocket (3) once the screw (8) has been inserted, fixing the device for its use.

Figure 14 a shows a part (1) inserted in the corresponding ferrule pocket (6) and stabilized with

the prisoner (8), being able to appreciate the interior (7) of the

splint (6) where the patient's teeth are housed.

In

the figure 15a I know shows a view side of the

set

of the device, prepared for power to be

Incorporated

in the mouth of a patient. Can understand

clearly

how acting on the screw (13) I know modify

the mandibular separation through the transmission parts (1) of the mandibular distance.

Possible movements that can be performed with the use of this device once incorporated into the patient's teeth, vertical movement (BB) and horizontal movement (CC) are indicated in figure 16a. In figure 17a, 18a and 19a The movement is shown once done.

Figure 17a indicates the vertical movement (B-B) in its maximum closed position. We see how the pocket (3) limits the movement internally. In other words, the depth of the interior space (4) defined inside each pocket (3) limits the penetration of the upper part

(24) of each piece (1) of transmission of the mandibular distance.

In figure 18a, the vertical movement (B-B) in its maximum open position is indicated. We see how the screw (8) located in the pocket (3) limits the opening movement.

Figure 19a shows the horizontal movement (C-C) in its lateral displacement position. We see how the screw (8) located in the pocket (3) allows this movement to act.

In figure 2 O a you can see how the device also allows us to perform laterally offset movements (D-D), thanks to the arrangement

existing between the pockets (3) and the pieces (1) controlled by the screws (8), and the dimensions of the windows (2).

This description is not extended, in the good

10 understand 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 practiced in other embodiments that differ in detail from that indicated by way of example of the description, and which will also achieve the protection that is sought. Likewise, it can be built in any

20 shape and size with the most suitable materials, as all of this falls within 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.

Claims (7)

1.-Adjustable mandibular advancement device, of the type used for intraoral treatment of upper airway obstruction problems, characterized by being made up of: an upper splint (6) of plastic material and another lower splint (6), where each one incorporates frontally a plastic cavity (5) in which a metallic pocket (3) is housed, which defines an interior space (4 ) hollow in which a distance transmission part (1) is housed and retained or mandibular separation, the transmission parts of the mandibular distancing being housed and retained in the pockets joined by means of guiding and coupling of mandibular distance regulation means. 2.- Adjustable mandibular advancement device according to claim 1, characterized in that the two pieces (1) of transmission of the mandibular distance, consist of an upper part (24) and a lower part (25), where the upper part of each piece (1) of transmission of the mandibular distance has a window (2), through which the means for retaining the pieces (1) are passed into the interior space (4) of the pockets (3) while the lower part (25) has guide means for guiding and coupling means for adjusting the mandibular distance. 3.-Adjustable mandibular advancement device according to the Claim 1, characterized in that the means for retaining the pieces (1) in the interior space (4) of the pockets (3) are captive screws (8) that through the window (2) thread over the threaded holes (15) arranged facing each other on the walls of the pockets (3). 4.- Adjustable mandibular advancement device according to claim 1, characterized in that the guiding means of the lower part (25) are perforations or holes (21) through which guides (23) are passed, which ensure the aligned advance, without deviations of the parts (1) of transmission of the mandibular advance. 5.- Adjustable mandibular advancement device according to claim 1, characterized in that the coupling means of the regulation means, in a possible embodiment, are threaded perforations (22) arranged between the holes (21). 6.- Adjustable mandibular advancement device according to claim 5, characterized in that the mandibular distance regulation means are screws (13) that thread the threaded perforations (22) made in the lower part (25) of the parts (1) of transmission of the mandibular distance. 7.- Adjustable mandibular advancement device according to claim 6, characterized in that it is a 50% double-threaded screw, on one left-hand threaded end, and on the other right-hand threaded end, having at one of its ends a hole for use a wrench or screwdriver adapted to the hole in question.