WO2020128408A1

WO2020128408A1 - Mandibular advancement device

Info

Publication number: WO2020128408A1
Application number: PCT/GB2018/053715
Authority: WO
Inventors: Philip Chapman
Original assignee: Philip Chapman
Priority date: 2018-12-20
Filing date: 2018-12-20
Publication date: 2020-06-25

Abstract

A mandibular advancement device (500), kit, and method of manufacture is described comprising a base plate (100), at least two substantially parallel rails (400) and running from a first base plate end (104) to a second base plate end (200), and a coupler (300) suitable for coupling to a jaw splint of the mandibular advancement device (500). The coupler (300) is adjustably affixed to the at least two substantially parallel rails (400). Adjustment means (450) connected to the coupler (300) and the base plate (100) are further provided. In use the adjustment means (450) alters and temporarily fixes the position of the coupler (300) relative to the base plate (300) in a position along a length of travel determined by a length of at least two substantially parallel rails (400).

Description

Mandibular Advancement Device

Field of the Invention

The present invention relates to a mandibular advancement device, kit, and a method of manufacturing thereof.

Background of the Invention

Snoring occurs during sleep as the mouth falls open and the lower jaw adopts a gaping position. This changes the shape of the airway and soft tissues in the throat become slack. As breath is drawn in and flows past these tissues they reverberate, causing a snore. If the tissues are particularly slack heavy snoring results.

One solution to the problem of snoring is the use of a mandibular advancement splint. This device fits to the teeth of a snorer and hold the upper and lower jaws in place relative to one another. Typically, the lower mandible is held forward of the upper mandible. This preserves the tension in the soft throat tissues, preventing reverberation and alleviates the symptoms of snoring. These devices are typically formed from two splints (the splints attaching to a snorer’ s teeth) and a coupling mechanism which holds the two splints together and in a special relationship as determined and pre-set by the snorer. The snorer adjusts the coupling mechanism iteratively in order to determine the optimal mandible displacement required to minimise or preferably cure the symptoms of snoring.

In many devices the coupling mechanism is enclosed and not visible during adjustment. This is because such devices are typically pressed out of metal plates for easy and cost-effective manufacture. This can lead to a snorer attempting to adjust the device outside its designed specification and causes accidental breakage.

Furthermore, as the coupling devices are enclosed it is difficult, if not impossible, to satisfactorily clean the device to preserve a high level of hygiene.

Summary of the Invention

According to a first aspect there of the present invention, there is provided a mandibular advancement device comprising a base plate, at least two substantially parallel rails running from a first base plate end to a second base plate end, a coupler suitable for coupling to a jaw splint of the mandibular advancement device, wherein, the coupler is adjustably affixed to the at least two substantially parallel rails, and adjustment means connected to the coupler and the base plate wherein in use the adjustment means alters and temporarily fixes the position of the coupler relative to the base plate in a position along a length of travel determined by a length of the at least two substantially parallel rails.

The substantially parallel rails ensure that the coupler runs true and is held firmly, this allows the coupler to connect to a coupler receiver strongly and reduces the risk of upper and lower jaw splints, connected by the coupler from becoming dislodged in use.

The at least two substantially parallel rails are preferably joined to the base plate using a single fixing point. The use of a single fixing point allows for easy construction and also reduces the risk of the device disassembling as there is only one way for the device to be disassembled.

The single fixing point is optionally at least partially embedded in a matrix of a jaw splint. At least partially embedding the single fixing point ensures that the device cannot inadvertently disassemble in use as the matrix prevents operation of the single fixing point. If the single fixing point is completely embedded in the matrix, the single fixing point permanently joins the at least two substantially parallel rails to the base plate.

The matrix is selected from the group, polymers, biodegradable polymers, acrylic. Such materials are typically used to form jaw splints, therefore the device does not require any special materials to permanently secure the single fixing point.

The adjustment means suitably comprises a threaded shaft. The use of a threaded shaft (or grub screw) allows the user to readily adjust the position of the coupler relative to the base plate in small and predictable increments.

The at least two substantially parallel rails advantageously locate into respective first and second base plate end recesses. The recesses cup and hold the ends of each rail in place preventing displacement of the rails and ensuring the rails remain parallel with respect to one another.

In an additional embodiment of the invention there is a lower jaw splint with a receiver for the coupler and an upper jaw splint, wherein the upper jaw splint comprises the base plate. Here the mandibular advancement device is embedded in the upper jaw splint. The upper jaw splint is advantageously made of the matrix the single fixing point is at least partially embedded in.

Alternatively, the present invention may be provided as a kit of parts suitable for constructing the mandibular advancement device comprising a base plate, at least two rails, a coupler, an adjustment means, and a coupler receiver.

The mandibular advancement device may be made using a method of manufacturing comprising the steps of attaching a coupler to at least two rails locating the least two rails in respective base plate recesses in the base plate such that the at least two rails are substantially parallel with respect to one another, locating an adjustment means to adjustably position the coupler relative to the base plate, and fixing the aforesaid together using a single fixing point.

The method of manufacturing may additionally comprise the further step of at least partially embedding the single fixing point in a matrix of a jaw splint. The matrix may be selected from the group, polymers, biodegradable polymers, acrylic.

Other aspects are as set out in the claims herein.

Brief Description of the Drawings

For a better understanding of the invention and to show how the same may be carried into effect, there will now be described by way of example only, specific embodiments, methods and processes according to the present invention with reference to the accompanying drawings in which:

Figure 1 shows elevation views of a base plate;

Figure 2 shows elevation views of an end wall;

Figure 3 shows elevation views of a coupler;

Figure 4 shows side and front views of a rail and adjustment means;

Figure 5 shows an exploded view of the mandibular advancement splint;

Figure 6 shows a perspective view of the mandibular advancement splint; and

Figure 7 shows the mandibular advancement splint embedded in an upper jaw splint with corresponding lower jaw splint and adjustment key.

Details Description of the Embodiments

There will now be described by way of example a specific mode contemplated by the inventors. In the following description numerous specific details are set forth in order to provide a thorough understanding. It will be apparent however, to one skilled in the art, that the present invention may be practiced without limitation to these specific details. In other instances, well known methods and structures have not been described in detail so as not to unnecessarily obscure the description.

With reference to figure 1, there is provided a base plate 100. The base plate 100 is preferably constructed from medical grade stainless steel or other suitable bio-inert (i.e. non-toxic, and stable when situated in vivo) material. The base plate 100 is substantially square and planar in shape. The base plate 100 may have rounded corners and a number of recesses 101 cut into two opposing sides of the square planar base plate. These provide substantially tabular sections 102 which ensure the base plate lOOcan key into the matrix forming an upper splint when the base plate 100 is secured in place. The tabs 102 created by the recesses 101 in the base plate 100 provide a greater fixing area than straight sides would and ensure that the base plate 100 will embed securely in the matrix.

On an end 103 of the base plate 100 not comprising the tabs 102, there is a projection 104 which is perpendicular to the largest area of the base plate. The projection 104 forms an end wall which forms the first base plate end. The end wall comprises recesses 105 suitable for receiving and holding a rail. The recesses 105 are in the form of a blind tunnel with their opening facing towards the centre of the base platelOO.

The first base plate end wall 104 comprises a stepped aperture 106 such that a first diameter

107 of the aperture facing the centre of the base plate 100 is greater than the second diameter

108 of the aperture facing away from the centre of the base plate. Preferable there a single step is used to make the transition between the greater and lesser diameters. This allows the recess to hold the adjustment means 450, which by way of example may be a grub screw or other suitable threaded bar or shaft, the adjustment means 450 having a head 451 with a hexagonal socket 452 to receive an Allen key 705. The head 451 of the adjustment means 450 may still be accessed through the side of the aperture with the second diameter 108 without the adjustment means 450 being able to pass through the aperture 106 due to the interference fit with the step. This allows a user to adjust the adjustment means 450 while ensuring the adjustment means450 remains securely installed on the base plate first end wall 104.

The first base plate end wall 104 is integral with the base plate 100 and 35 may not be separated from it. As such it can be considered to be a subsidiary feature of the base plate 100 and is not an element in its own right. The base plate 100 may be designed as such that a projection forming a first base plate wall 104 is not required.

The base plate 100 further comprises a single fixing point 111 arranged at the second base plate end. The second base plate end is arranged on an opposite side of the base plate 100 to the first base plate end, and end wall 104. The single fixing point may comprise a pair of through-going circular apertures 110 to receive a bolt. One end of the apertures 110 may be flared such that a head of the bolt is countersunk into the base plate 100 to ensure it will not loosen with use lOand does not protrude from the surface of the base plate 100.

The flared end of the apertures is located on opposite side of the base plate 100 to the projection forming the first base plate end wall 104.

With reference to figure 2, there is provided a second base plate end wall 200. The second base plate end wall 200 comprises recesses 201 suitable for receiving and holding a rail that are complimentary to the recesses 105 of the first base plate end wall 104, such that a pair of rails in situ may run in parallel between the first and second base plate end walls 104, 200. The recesses 201 are in the form of a blind tunnel with their opening facing towards the centre of the base plate 100 when the second base plate end wall 200 is correctly in position upon the base plate 100.

The second base plate wall 200 comprises a recess 202 in the form of a blind tunnel complementary to the stepped aperture 106 of the first base plate wall 104 such that an adjustment means 450, when correctly positioned in the mandibular advancement device, is held in the respective stepped aperture 106 and recess 202 between the first and second base plate walls 104, 200. When in position the adjustment means 450 may freely rotate about a long axis but may not be removed from the mandibular advancement device.

The second base plate end wall 200 further comprises a single fixing point 203

complimentary to that of the base plate 100 such that the second base plate end wall 200 and the base plate 100 may be connected together through the single fixing point 203.

The second base plate end wall’s single fixing point 203 may comprise a pair of blind tunnels 204 with an internal thread to receive a bolt. The threaded blind tunnels 204 are arranged to line up with the base plate single fixing point apertures 110.

With reference to figure 3 there is provided a coupler 300 of the mandibular advancement device. The coupler 300 comprises a body 301 having apertures 302 to receive substantially parallel rails 400, such that the coupler 300 can ride along the length of the rails 400, but not be removed from the mandibular advancement device, nor derailed.

A further threaded aperture 303 is provided with thread complimentary to the adjustment means, such that as the adjustment means is rotated the body 301 of the coupler is advanced along the length of the substantially parallel rails 400.

Attached to the body 301 is a hook shaped member (or hook) 304, which stands proud of the surface of the mandibular advancement device such that it may couple to a coupler receiver located on a separate splint of the mandibular advancement device.

The coupler 300 comprises a rounded profile 305 to facilitate easy decoupling from the lower jaw splint. The fit of the coupler 300 and the coupler receiver should be such that a user may not unwittingly decouple the upper and lower jaw splints of the mandibular advancement device while asleep. Preferably the coupler 300 and coupler receiver should only disengage on the snorer removing the mandibular advancement splint and consciously attempting to decouple the upper and lower jaw splints.

In order to achieve a secure coupling, located beneath a point of the hook 304 is a lip 306 arranged such that a tip 307 of the lip 306 is aligned with the point 308 of the hook. This ensures a secure fit about the coupler receiver and ensures the hook 304 cannot be unconsciously disengaged by a slumbering user.

With reference to figure 4 there is shown one of the at least two substantially parallel rails 400 and an adjustment means 450. Referring to the rail 400, there is provided a dowel pin with rounded edges 401. The rounded edges 401 facilitate 35 location of the dowel pin in the recesses of the first and second base plate end walls 104, 200 and allow the dowel pin to rotate, but not be removed from, the base plate end walls 104, 200 when the dowel pin is correctly positioned.

The rail 400 is substantially cylindrical to provide a smooth-running surface for the body of the coupler 301 to run along. Preferably the fit between the rail 400 and the complimentary aperture 302 of the coupler should be tight, by way of non-limitative example, the diameter of the aperture 302 could be 2mm, while the rail 400 has an outer diameter of 1.99mm. With reference to figure 5 there is shown an exploded view of the mandibular advancement device 500. It can be seen that once the rails 400, adjustment means 450, and coupler 300 are inserted in to their respective apertures and recesses on the base plate end wall 104, the second base plate end wall 200 can be secured in place using the single fixing point 108.

Inserting two bolts 201 into the single fixing point 108 and cinching the bolts up hold all the components of the mandibular advancement device 500 in place. The single fixing point 108, while using two fasteners 501, is referred to as a single fixing point 108 as this is only route that can be used to disassemble the mandibular advancement device.

With reference to figure 6 there is shown the assembled mandibular advancement device 500. The rails 400, adjustment means 450, coupler body 301 and hook 304 are exposed and therefore accessible for a user to clean and maintain good hygiene.

Furthermore, the exposed coupler body 301 allow a user to easily visualize the remaining travel available for adjustment of the adjustment means. This prevents over tightening of the mandibular adjustment device 500.

The base plate stepped aperture 106 allows easy adjustment of the adjustment means 450 using a key with hexagonal cross section 705 (an Allen key).

Referring to figure 7 there is shown the mandibular advancement device 500 embedded in the upper jaw splint 701. Likewise, the coupler receiver 702 (a lozenge shaped plate-like member comprising at least one aperture 703 towards an end of the lozenge) is embedded in the lower jaw splint 704. The references to the mandibular advancement device 500 being embedded in an upper jaw splint 701 and the coupler receiver 702 being embedded in the lower jaw splint is by way of non-limitative example. It will be clear to one skilled in the art that it is immaterial which of the upper and lower splints that the mandibular advancement device 500 and coupler receiver 702 are embedded in. The mandibular advancement device 500 and coupler receiver 702 simply need to be arranged such that they are complementary with respect to one another in order to allow the coupler 300 to engage with the coupler receiver 702. The parallel rails 400 are exposed and not surrounded by any casing. This has the advantage that a user can easily clean the mandibular advancement device. As there is no casing, other elements of the mandibular advancement device 500 are also exposed including the base plate 100, adjustment means 450, and the coupler 300. All elements of the mandibular advancement device are therefore easy to clean and maintain.

The exposed configuration of the mandibular advancement device 500 also allow the user to easily gauge the remaining adjustment available in the device for advancing/retracting the coupler 300 relative to the base plate 100 using the adjustment means 450. This reduces the risk of the mandibular advancement device 500 being overtightened and elements of the adjustment means 450 being damaged, such as rounding off the hex socket 452 in the adjustment means 450 or stripping the coupler body aperture threads 303.

One or more spring washers may be applied to any of the screws or threaded elements to reduce the likelihood for the parts disengaging.

Claims

1. A mandibular advancement device comprising:

a base plate,

at least two substantially parallel rails running from a first base plate end to a second base plate end,

a coupler suitable for coupling to a jaw splint of the mandibular advancement device, wherein,

the coupler is adjustably affixed to the at least two substantially parallel rails, and adjustment means connected to the coupler and the base plate wherein in use the adjustment means alters and temporarily fixes the position of the coupler relative to the base plate in a position along a length of travel determined by a length of the at least two substantially parallel rails.

2. A mandibular advancement device as claimed in claim 1 wherein the at least two substantially parallel rails are attached to the base plate using a single fixing.

3. A mandibular advancement device as claimed in claim 2 wherein the single fixing is at least partially embedded in a matrix of a jaw splint.

4. A mandibular advancement device as claimed in claim 3 wherein the matrix is

selected from the group, polymers, biodegradable polymers, acrylic.

5. A mandibular advancement device as claimed in any preceding claim wherein the adjustment means comprises a threaded shaft.

6. A mandibular advancement device as claimed in any preceding claim wherein the at least two substantially parallel rails locate into respective first and second base plate end recesses.

7. A mandibular advancement device as claimed in any preceding claim further comprising a lower jaw splint with a receiver for the coupler and an upper jaw splint, wherein the upper jaw splint comprises the base plate.

8. A kit of parts suitable for constructing the mandibular advancement device claimed in claim 1 comprising:

a base plate

at least two rails

a coupler

an adjustment means and

a coupler receiver.

9. A method of manufacturing a mandibular advancement device comprising the steps of attaching a coupler to at least two rails locating at least two rails in respective base plate recesses in a base plate such that the at least two rails are substantially parallel with respect to one another, locating the adjustment means to adjustably position the coupler relative to the base plate, fixing the aforesaid together using a single fixing point.

10. A method of manufacturing a mandibular advancement device as claimed in claim 9 comprising the further step of at least partially embedding the single fixing point in a matrix of a jaw splint.

11. A method of manufacturing a mandibular advancement device as claimed in claim 10 wherein the matrix is selected from the group, polymers, biodegradable polymers, acrylic.