Mandibular advancement device

Abstract

The invention provides a mandibular advancement device. The device includes an intraoral portion and an extraoral portion. The intraoral portion includes a body portion. The body portion includes a floor and a roof. The floor is adapted to receive a pair of opposed arms that extend rearwardly and outwardly from the floor into the oral cavity when the device is worn. Each arm includes a posterior intraoral maxillary posterior abutment surface. The floor includes a threaded hole on each side adjacent to the respective arm, such that the threaded hole extends from the respective arm toward the edge of the floor. Each hole is adapted to receive a screw that can be threaded into the threaded hole, and when the screw has been threaded in sufficiently, the inner end of the screw contacts its respective arm, whereupon further turning of the screw forces the arm to move toward its opposite arm, such that the position of the posterior intraoral maxillary posterior abutment surface of the moving arm moves to a new position.

Description

Technical Field

[0001] This invention relates to a mandibular advancement device, and more particularly to a device worn by a person to prevent obstructive sleep apnea, specifically to an adjustment component inside the oral cavity for use in the device. Background Technology

[0002] Mandibular advancement devices of the type mentioned in this specification have been disclosed in WO 2019 / 071291 A1 and WO 2006 / 072147. The disclosed mandibular advancement devices have an intraoral and an extraoral portion. This invention relates primarily to the intraoral portion of the device.

[0003] Because of the wide variation in the size and shape of the mouths of users of these types of devices, and in order to keep manufacturing costs low, these devices are manufactured in three wide sizes: small, medium, and large. However, further adjustments are needed within each of these wide sizes to maximize comfort and fit for each particular user, and also to maximize the effectiveness of the device.

[0004] One of the main issues surrounding the fit and comfort of the device is ensuring that the maxillary posterior abutment surfaces of the various arms inside the mouth engage in the correct position, conforming to the wearer's maxillary posterior characteristics. These maxillary posterior abutment surfaces are designed to loosely engage with the wearer's molars or premolars and prevent any lateral movement of the device within the wearer's mouth. Importantly, the device must not apply sufficient lateral force to the wearer's teeth, allowing tooth displacement to occur over time. Furthermore, applying unnecessary force will significantly negatively impact the wearer's comfort while wearing the device and may reduce its usability and performance.

[0005] Therefore, the object of the present invention is to provide an adjustment component inside the oral cavity for a mandibular advancement device, which at least alleviates some of the aforementioned problems. Summary of the Invention

[0006] According to a first aspect, the present invention provides an adjustment component for a mandibular advancement device, the device comprising an interior and an exterior oral cavity, wherein the interior oral cavity includes a main body. The main body includes a base plate and a top plate. The base plate is adapted to receive a pair of opposing arms that, when the device is worn, extend rearward and outward from the plate into the oral cavity. Each arm includes a posterior intraoral maxillary retraction surface. The base plate includes an adjustment component on each side, the adjustment component being adapted to act on the respective arm and move its position relative to the opposing arm such that the position of the posterior intraoral maxillary retraction surface of the moving arm is moved to a new position.

[0007] Preferably, the base plate includes a threaded hole on each side adjacent to the corresponding arm, such that the threaded hole extends from the corresponding arm toward the edge of the plate. Each hole is adapted to receive a screw that can be screwed into the threaded hole, and when the screw has been fully screwed in, the inner end of the screw contacts its corresponding arm, and further rotation of the screw forces the arm to move relative to its opposite arm, such that the position of the posterior maxillary abutment surface of the moving arm moves to a new position.

[0008] Preferably, each threaded hole in the base plate is recessed from the outer edge backward, and the opening of the threaded hole is located in a vertical slot.

[0009] Preferably, the top plate is adapted to cover and connect with the bottom plate to form a main body and enclose a portion of each arm within the main body. The top plate includes a generally vertically downward extending side protrusion that is aligned with and adapted to insert into a vertical slot and conforms to the shape of the vertical slot, thereby covering the threaded hole and screw entrance and forming a main body with a generally smooth outer surface.

[0010] Preferably, each side protrusion includes an opening positioned to align with and be concentric with the threaded hole and screw.

[0011] Preferably, the size of each orifice is such that an adjusting tool, such as a screwdriver or Allen wrench, can be inserted and thus engage with and act on the screw, but the size is too small to allow the screw to exit through the orifice, thereby making the protrusion serve as an abutment to prevent the screw from falling out of the body.

[0012] According to the second embodiment, the adjustment component is electromechanical or magnetic, thus eliminating the need for openings on the top or bottom plate, allowing the body to have a substantially continuous surface, and enabling easier and more efficient cleaning and disinfection.

[0013] Preferably, each arm is integrally formed in the top or bottom plate and is made of a suitable elastic material.

[0014] Preferably, each arm is naturally biased relative to the other arm, such that when no external force is applied, such as the impact of the screw when the adjusting tool operates on the screw, the arm naturally maintains maximum extension.

[0015] According to a third embodiment of the invention, each arm is manufactured separately from a top plate or a bottom plate, and the top plate or bottom plate includes a column portion whose profile is configured to resist rotation about the column, and the front end of each arm includes a hole having a shape complementary to the hole and adapted to receive the column portion within the hole, and the position is the natural rest position of each arm when the arm is not subjected to external forces, such as the impact of a screw when an adjusting tool operates a screw.

[0016] According to a fourth embodiment of the invention, each arm is manufactured separately from the top plate or bottom plate, and the top plate or bottom plate includes a column portion having a circular profile, and the front end of each arm includes a hole adapted to receive the column portion and allow the arm to rotate freely about its respective column portion, and the body portion includes a separate biasing member that acts on each respective arm, and when each arm is not subjected to external forces, such as the impact of a screw when an adjusting tool operates a screw, the biasing member holds the arm in its maximum extended position.

[0017] According to a fifth embodiment of the present invention, the biasing component is a coil spring.

[0018] According to a sixth embodiment of the present invention, the biasing component is a leaf spring.

[0019] According to a seventh embodiment of the invention, the biasing component is an elastic tab included in a top plate or a bottom plate, and each of the elastic tabs is adapted to strike a corresponding arm.

[0020] Preferably, the top or bottom plate includes an aperture or window associated with a measurement increment indicator, which indicates the current position of each arm when the arm is forced to a new position by the flathead screw.

[0021] Optionally, the main body includes electronic sensor components adapted to sense the current position of each arm and feed that position data to a wireless transmission component, such as a Bluetooth transmitter.

[0022] Preferably, the data transmitted by the wireless transmission component is processed by an application on a portable computing device such as a smartphone or tablet.

[0023] In another aspect, the present invention is a method for adjusting a mandibular advancement device to improve the fit and comfort of the wearer of the device, the method comprising the following steps:

[0024] a. Select appropriate equipment from small, medium, and large-sized devices; and

[0025] b. Insert the device into the wearer's mouth; and

[0026] c. The fit and comfort of the device are determined by supporting each intraoral maxillary abutment surface on the extraoral maxillary anterior abutment surface; and

[0027] d. Receive feedback from the wearer regarding the fit and comfort; and

[0028] e. If necessary, use an appropriate tool inserted into the adjustment hole to turn the flathead screw and force each corresponding arm to change position, thereby changing the position of each posterior maxillary abutment surface in the posterior oral cavity to provide a customized fit best suited to the wearer's mandible.

[0029] Preferably, the method further includes the step of using an aperture or window and its associated measurement increment indicator to record the most comfortable setting for a particular wearer.

[0030] Optionally, the method further includes the steps of: transmitting the position of each arm in an application on a portable computing device, such as a smartphone, using sensor components and wireless transmission components, and using the application to associate the optimal position of each arm with the wearer. Attached Figure Description

[0031] Examples of the invention will now be described with reference to the accompanying drawings, in which:

[0032] Figure 1 It is an isometric view of the top side of the base plate.

[0033] Figure 2 This is another perspective view of the top of the base plate, which includes a pair of flat-head screws.

[0034] Figure 3 This is an exploded view of the top and bottom slabs.

[0035] Figure 4 It is a three-dimensional view of the top and bottom plates connected together to form the main body.

[0036] Figure 5 The approximate interior of the oral cavity is shown in the assembled mandibular advancement device.

[0037] Figure 6 Another embodiment of the invention is shown, which allows the position of each arm to be measured.

[0038] Figure 7 Another embodiment of the invention is shown, which includes an electronic sensor that senses the corresponding position of each arm and optionally sends the data to an application on a portable computing device such as a smartphone.

[0039] Figure 8 (a) and (b) show another preferred embodiment of the invention, wherein each arm is manufactured separately from the body and each arm is capable of being placed on a corresponding post prefabricated in the base plate and is capable of rotating freely about its corresponding post, and a natural leaf spring is used to keep each arm separate.

[0040] Figure 9 (a) and (b) show another preferred embodiment of the invention, wherein each arm is manufactured separately and each arm can be placed on a corresponding pile that has been prefabricated in the base plate, however each arm cannot rotate about its corresponding pile, thereby remaining in its maximum extended position.

[0041] Figure 10(a) and (b) illustrate another preferred embodiment of the invention, which uses a pair of conventional helical springs to hold each corresponding arm in its maximum extended position. Detailed Implementation

[0042] First go to Figure 1 The diagram shows an isometric view of the top of the base plate 1. The base plate 1 is part of the main body of the oral cavity of the mandibular advancement device. The base plate 1 includes a pair of arms 3 and 3'. Each of the arms 3 and 3' extends rearward into the wearer's oral cavity. In this preferred embodiment, each arm is integrally formed in the base plate at members 5 and 5', respectively. Each of the arms 3 and 3' is made of a suitable elastic material that will elastically yield under the influence of external forces. When no external force is applied, each arm remains in its maximum extended position relative to its opposite arm.

[0043] Adjacent to each arm are threaded holes 7 and 7'. Each hole is reset from the edge of the base plate 1 and is substantially centered in the corresponding slots 9 and 9'. Each threaded hole 7 and 7' opens at its innermost end.

[0044] Each arm 3 and 3' also has gaps 11 and 11' respectively, which allow each arm to move into the gaps 11 and 11' when subjected to external force, so that the arms can be brought closer together.

[0045] Go to Figure 2 We show a pair of flathead screws 13 and 13' suitable for screwing into each corresponding threaded hole. The flathead screws can be turned using tools such as a screwdriver or an Allen wrench. As each screw is turned, the innermost end of the final screw strikes the outermost end of its corresponding arm. This forces the arm to yield under the force applied by the screw. This causes the corresponding arm to move in the direction indicated by the arrow.

[0046] Go to Figure 3 We show a top plate 15 prepared for connection to the base plate 1. The top plate 15 includes a pair of downwardly extending protrusions 17 and 17'. The size and shape of each protrusion are chosen such that when the top and base plates are connected, the protrusions fit flush with corresponding slots 9 and 9'. Each protrusion 17 and 17' includes small orifices 19 and 19'. These orifices are adapted to be concentric with holes and flathead screws when the body is assembled. The orifices are sized such that a tool can pass through and engage the head of the flathead screw, allowing it to rotate to adjust the position of each arm. Their size is also configured such that if the screw unfolds within the threaded hole, the orifice is too small for the flathead screw to retract through it. Each corresponding protrusion 17 and 17' thus serves as an abutment to prevent its corresponding flathead screw from falling out of the body.

[0047] exist Figure 4In the middle, the main body is assembled and it is shown how the protrusion 17 in the top plate 15 is assembled flush with the slot in the bottom plate 1.

[0048] Figure 5 The main body, comprising a top plate 15 and a bottom plate 1, is shown and assembled with other intraoral components of the mandibular advancement device. Adjusting each corresponding flathead screw by inserting a tool through orifices 19 and 19' causes arms 3 and 3' to move closer together, as indicated by the arrows. In this embodiment, loosening the flathead screws returns the corresponding arm to its normal resting position due to the natural elasticity of the material used to manufacture the arms.

[0049] Figure 6 Optional features on the top plate 15 are shown. In this embodiment of the invention, a pair of windows 21 and 21' are provided. Each window includes measuring scales 23 and 23'. These provide the user with visual assistance in determining the position of each arm 3 and 3'. The user can then determine the optimal arm position for a particular wearer of the device. This will particularly help the user set up the subsequent device for a specific wearer and manually position the arms to that particular person's initial optimal position.

[0050] Figure 7 Another preferred embodiment of the invention is shown. In this view,

[0051] The main body is equipped with electronic sensors 25 and 25'. These sensors electronically sense the position of each arm 3 and 3'. The location data is then optionally transmitted via a wireless device 27 to a portable computing device, such as a smartphone. The smartphone has an application installed that links the location data to a user account and records the selected position of each arm that the wearer finds most comfortable. This data is then used when setting up an assistive device or replacing a replacement device for that particular wearer.

[0052] Figure 8 (a) and (b) illustrate a preferred embodiment of the invention, wherein a pair of natural leaf springs 29 and 29' are pre-fabricated in a base plate 1. Each arm 3 and 3' is manufactured separately from the base plate 1, and each arm includes circular holes 33 and 33' at its front end, respectively, which are configured to rest on posts 31 and 31'. Each post also has a matching circular profile. Each arm is then rotatable about its corresponding post, however, each arm is biased to its maximum extension position by the force applied thereto by the corresponding leaf spring.

[0053] Figure 9(a) and (b) illustrate another preferred embodiment of the invention. In this embodiment, each arm 3 and 3' is manufactured separately from the base plate 1; however, the outline of each hole 33 and 33' is no longer circular. Each post 31 and 31' on which the respective arm can be placed has a matching non-circular outline. The shape of the post and the holes on the arm prevent the arm from rotating about the post, and this keeps each arm in its maximum extended position. Any force applied to the corresponding arm by the flathead screw will cause that arm to move toward its opposite arm. When the force is removed, the arm will move back to its maximum extended position under the influence of its own elasticity.

[0054] Figure 10 (a) and (b) illustrate another preferred embodiment of the invention. In this embodiment, each of the arms 3 and 3' is manufactured separately from the base plate 1, and each is capable of being placed on prefabricated posts 31 and 31', and the holes in the posts and arms have circular profiles, allowing each arm to rotate about its respective post. However, the assembly includes a pair of springs 35 and 35', and each spring applies a biasing force to its respective arm, which holds the arm in its maximum extended position until acted upon by its respective flathead screw.

[0055] Therefore, as can be seen from the above preferred embodiments, the present invention provides users with an easy way to set the inside of the mandibular advancement device, thereby improving its fit, wearer comfort, and providing more effective functionality.

[0056] While the foregoing description includes preferred embodiments of the invention, it should be understood that many variations, alterations, modifications, and / or additions can be made to the construction and arrangement of the aforementioned components without departing from the essential characteristics, spirit, or scope of the invention. For example, the adjusting component in the preferred embodiment uses threaded holes and associated flat-head screws; however, other devices, such as electromechanical or magnetic devices, are also possible for adjusting the position of the arm relative to the other arms. These should be considered within the scope of the invention. Such a device provides the ability to avoid requiring orifices in both the top and bottom plates, thereby making their respective surfaces continuous and thus easier to clean and disinfect between uses.

[0057] It should also be understood that the word “comprise” and its variations, such as “comprises” and “comprising”, are used in this specification. Unless the context requires otherwise, such use is intended to imply the inclusion of one or more of the stated features, but should not be construed as excluding the presence of one or more other features.

[0058] References to any prior art in this specification are not and should not be construed as an admission or in any way implying that such prior art is part of common general knowledge.

Claims

1. A mandibular advancement device, comprising: The oral cavity interior includes a main body comprising a base plate and a top plate. The base plate is adapted to accommodate a pair of opposing arms that, when worn, extend posteriorly and laterally from the base plate into the oral cavity. Each arm includes an intraoral maxillary posterior abutment surface, and... outside the mouth, in, The mandibular advancement device includes adjustment components disposed on each side of the base plate, the adjustment components being adapted to act on a corresponding arm to move the corresponding arm toward its opposite arm, thereby moving the position of the corresponding arm at the intraoral maxillary posterior abutment surface to a new position. Each of the arms is one of the following: - Each of the arms is integrally formed in the top plate or the bottom plate and is made of a suitable elastic material; or - Each of the arms is manufactured onto the top plate or the bottom plate, and each arm includes a hole at its front end, the hole having a shape complementary to the hole and adapted to receive a column portion on the top plate or the bottom plate within the hole, and When not subjected to external force, each of the arms is in its maximum extended position relative to each other.

2. The mandibular advancement device according to claim 1, wherein, The adjusting component includes a flathead screw, and each side of the base plate of the mandibular advancement device includes a threaded hole adjacent to a corresponding arm, such that the threaded hole extends from the corresponding arm toward the edge of the base plate, and wherein each threaded hole is adapted to receive a flathead screw capable of being screwed into the adjusting component, and when the flathead screw has been fully screwed into the threaded hole, the inner end of the flathead screw contacts its corresponding arm, so that further rotation of the flathead screw forces the corresponding arm to move relative to its opposite arm, such that the position of the corresponding arm at the posterior maxillary abutment surface of the posterior oral cavity moves to a new position.

3. The mandibular advancement device according to claim 2, wherein, Each of the threaded holes in the base plate of the mandibular advancement device is recessed rearward from the outer edge, and the openings of the threaded holes are respectively located in vertical slots.

4. The mandibular advancement device according to claim 3, wherein, The top plate is adapted to cover the bottom plate and be connected to the bottom plate to form the main body and to encapsulate a portion of each arm within the main body.

5. The mandibular advancement device according to claim 4, wherein, The top plate of the mandibular advancement device includes a generally vertically downward extending side plate that is aligned with and adapted to be inserted into the vertical slot and conforms to the shape of the vertical slot, thereby covering the opening of the threaded hole and the flat-head screw, and forming the body portion having a generally smooth outer surface.

6. The mandibular advancement device according to claim 5, wherein, Each of the side tabs includes an opening positioned to align with and be concentric with a threaded hole and a flathead screw.

7. The mandibular advancement device according to claim 6, wherein, Each of the orifices is sized such that an adjustment tool can be inserted and thus engage with and act on the flathead screw, but the adjustment tool is too small to allow the flathead screw to exit through the orifice, thereby making each of the side tabs act as a support to prevent the flathead screw from falling out of the body.

8. The mandibular advancement device according to claim 1, wherein, If each of the arms is integrally formed in the top plate or the bottom plate, then each of the arms is naturally biased relative to the other arm, and when not subjected to external force, each of the arms rests naturally in the maximum extended position.

9. The mandibular advancement device according to claim 1, wherein, If each arm of the mandibular advancement device is manufactured onto the top plate or the bottom plate, the profile of the corresponding post for each arm is configured to resist rotation about the post, such that when the post is received in the hole, each arm rests naturally in the maximum extended position when no external force is applied.

10. The mandibular advancement device according to claim 1, wherein, If each arm of the mandibular advancement device is manufactured to the top plate or the bottom plate respectively, then the corresponding column has a circular profile that allows the arm to rotate freely about its corresponding column, and the body includes a separate biasing member that acts on each corresponding arm and holds the arm in the maximum extension position when no external force is applied to each arm.

11. The mandibular advancement device according to claim 10, wherein, The biasing component of the mandibular advancement device is at least one helical spring.

12. The mandibular advancement device according to claim 10, wherein, The biasing component of the mandibular advancement device is a leaf spring.

13. The mandibular advancement device according to claim 10, wherein, The biasing component of the mandibular advancement device is an elastic tab included in the top plate or the bottom plate, the elastic tab being adapted to strike a corresponding arm.

14. The mandibular advancement device according to claim 1, wherein, The top or bottom plate of the mandibular advancement device includes a window associated with a measurement increment indicator, which indicates the current position of each arm when the arm is forced to a new position by the adjustment component.

15. The mandibular advancement device according to claim 14, wherein, The main body includes an electronic sensor component adapted to sense the current position of each arm and feed the data of the current position to a wireless transmission component.

16. The mandibular advancement device according to claim 15, wherein, The data transmitted by the wireless transmission component is processed by an application on a portable computing device.

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