WO2021119533A1

WO2021119533A1 - Liners for a mandibular advancement device

Info

Publication number: WO2021119533A1
Application number: PCT/US2020/064676
Authority: WO
Inventors: Sung Kim; David W. Kuhns; Leonard A. Liptak
Original assignee: ProSomnus Sleep Technologies, Inc.
Priority date: 2019-12-12
Filing date: 2020-12-11
Publication date: 2021-06-17

Abstract

Dental device liners for use with a patient's teeth, having arch-shaped mandible and maxilla, comprising at least one segment having liner buccal wall, liner lingual wall, and at least two cavities; the segment having length of at least two adjacent teeth; each cavity having inverse shape of one of the at least two adjacent teeth; wherein the component is configured to fit within a channel of a splint of a mandibular advancement device (MAD), the channel having a floor and two side walls, the side walls being a MAD buccal wall and a MAD lingual wall; wherein when the liner is placed within the channel, the liner buccal wall abuts the MAD buccal wall and the liner lingual wall abuts the MAD lingual wall; wherein the liner is digitally designed according to a prescription from a health care provider; wherein the liner is automatedly manufactured according to the digital design.

Description

LINERS FOR A MANDIBULAR ADVANCEMENT DEVICE

RELATED APPLICATIONS

[001] The present application claims priority to the U.S. Provisional Application Serial No. 62/947,394 filed December 12, 2019, by KIM et ah, and entitled “LINERS LOR A MANDIBLE ADVANCEMENT DEVICE,” the entire disclosure of which, including any drawings, is incorporated by reference herein.

FIELD OF THE INVENTION

[002] The present invention is in the field of mandibular advancement devices (MADs), and in particular in the field of a liner for use with the MADs.

BACKGROUND OF THE DISCLOSURE

[003] MADs are well-known in the art. MADs need to be rigid so that they can move the mandible forward without themselves being deformed. The rigidity provides discomfort for the patient and poor retention of the MAD over the dentition.

SUMMARY OF THE INVENTION

Disclosed herein are dental device liners for use with a patient’s teeth, the patient having a mandible and a maxilla, each of the mandible and maxilla being arch- shaped, the component comprising: at least one segment having a liner buccal wall, a liner lingual wall, and at least two cavities; the segment having the length of at least two adjacent teeth of the patient; each cavity having the inverse shape of one of the at least two adjacent teeth; wherein the component is configured to fit within a channel of a splint of a mandibular advancement device (MAD), the channel having a floor and two side walls, the side walls being an MAD buccal wall and an MAD lingual wall; wherein when the liner is placed within the channel, the liner buccal wall abuts the MAD buccal wall and the liner lingual wall abuts the MAD lingual wall; wherein the liner is digitally designed according to a prescription from a health care provider; wherein the liner is automatedly manufactured according to the digital design. BRIEF DESCRIPTION OF THE DRAWINGS

[004] Figure 1A shows an embodiment of a splint used with the liners disclosed herein. Figure IB shows an embodiment of the liners disclosed herein. Figure 1C shows an embodiment of a liner disclosed herein nestled within the splint.

[005] Figure 2A shows an embodiment of the liners disclosed herein nestled within the splint, where both of the liner buccal and lingual walls are shorter than their device wall counterparts. Figure 2B shows an embodiment of the liners disclosed herein nestled within the splint, where the liner lingual wall is longer than the device lingual wall, whereas the liner buccal wall is shorter than the device buccal wall.

[006] Figure 3 shows an exploded view of the splint, liners, and the dentition.

DET AIDED DESCRIPTION OF THE EMBODIMENTS

[007] Disclosed herein are liners to be used with a dental device, such as a mandibular advancement device (MAD). The liners are configured to fit over a patient’s teeth, whether the upper teeth, i.e., the teeth on the maxilla, or the lower teeth, i.e., the teeth on the mandible and a maxilla.

[008] MADs are well-known in the art. See, for example, USP 9,820,882, USP 9,808,327, US Patent Application Publications, 2018/0024530 and 2019/0105191, International Publication WO 2019/018309 Al, and International Patent Application No. PCT/US2019/029471. The disclosure of all the publications enumerated in this paragraph (“the above-incorporated publications”) are hereby incorporated by reference herein, including any drawings, in particular such aspects of the disclosure that disclose an MAD, a method of design thereof, a method of manufacture thereof, or an accessory therefor.

[009] An embodiment of a MAD used with the liners disclosed herein is presented in the above-incorporated USP 9,820,882, where the discussion on the structure of the MAD from Col. 3, line 29 through col. 10, line 35, and drawings FIG. 1 - FIG. 9 are specifically incorporated by reference herein.

[0010] An embodiment of a method of digitally designing the MADS suitable for use with the presently disclosed liners is disclosed in the above-incorporated USP 9,808,327, where the design of the MAD from col. 2, line 54 - col. 10, line 35, and FIG. 1, are specifically incorporated by reference herein.

[0011] FIGs. 1A & IB show an embodiment of a simple presentation of the splint 170 and the liner 180. In some embodiments, the splint 170 comprises a buccal wall 104, which when the MAD is worn by the patient, the buccal wall 104 lies adjacent to the inner cheek tissue 190.

[0012] Throughout the present disclosure, a “wall” refers to a portion of the device under discussion (e.g., a liner, a MAD, etc.) that lies substantially perpendicularly to the occlusal plane of the patient’s dentition, whereas a “floor” refers to a portion of the device under discussion (e.g., a liner, a MAD, etc.) that lies substantially parallel to the occlusal plane of the patient’s dentition.

[0013] In some of these embodiments, the splint 170 also comprises a lingual wall 106, which when the MAD is worn by the patient, the lingual wall 106 lies adjacent to the tongue. Connecting the two walls together is the splint floor 108. The two walls 104,106 and the floor 108 form a channel 118. The “interior” of the channel 118 is the space surrounded by the two walls 104,106 and the floor 108, whereas the “exterior” of the channel 118 is the space that lies outside of the space surrounded by the two walls 104,106 and the floor 108.

[0014] In some embodiments, the liner comprises at least one segment having a liner buccal wall 110, a liner lingual wall 112, and at least two cavities. In some embodiments, each cavity of the liner is configured to fit over a tooth. Accordingly, each cavity is milled to have the inverse shape 116 of the tooth that will fit into the cavity. By “inverse shape” it is meant that a tooth fits into the cavity analogous to how a hand fits into a glove.

[0015] In some of these embodiments, the segment has the length of at least two adjacent teeth of the patient. The length of a tooth is measured from the anterior-most point on the tooth to the posterior-most point on the tooth, while travelling along the curvature line of the arch of mandible or maxilla, whichever is relevant. Accordingly, the segment covers at least two teeth when the dental device is worn by the patient.

[0016] As shown in FIG. 1C, the liner disclosed herein is configured to fit within the channel 118 of the MAD splint, such that the liner buccal wall 110 abuts the MAD buccal wall 104 and the liner lingual wall 112 abuts the MAD lingual wall 106.

[0017] In some embodiments, the liner lingual wall 112, is longer than the device lingual wall 106. In these embodiments, the height of exposed liner 214 (FIG. 2B) is the difference between the height of the liner lingual wall 112 and the height of the device lingual wall 106. A ratio of height of exposed liner to height of the device lingual wall is calculated. This ratio is referred to as “the height ratio.” Thus, a height ratio = 1 indicates that the liner lingual wall is twice the length of the device lingual wall. Similarly, a height ratio = 0 indicates that the liner lingual wall and the device lingual wall are of the same length.

[0018] A higher height ratio provides greater comfort for the patient when wearing the dental device, while creating better retention of the dental device, as these criteria are compared with a device having a lower height ratio.

[0019] In some embodiments, the at least one of the two adjacent teeth is a molar, a premolar, a canine, or an incisor. In some embodiments, the at least one of the two adjacent teeth is a molar. In other embodiments, both adjacent teeth are molars.

[0020] In some embodiments, the liner is a single segment that curves around the arch of the mandible or maxilla and is in contact with teeth on both sides of the jaw. In some of these embodiments, the segment is configured to be placed over the patient’s entire upper dentition or over the patient’s entire lower dentition.

[0021] In other embodiments, the liner comprises two disconnected segments. In some of these embodiments, one disconnected segment is in contact with at least one tooth, e.g., a molar, on the right side of the jaw, while the other disconnected segment is in contact with at least one tooth, e.g., a molar, on the left side of the jaw. Thus, in some embodiments, one of the two disconnected segments is configured to be placed over the patient’s left set of at least two adjacent teeth, and another of the two disconnected segments is configured to be placed over the patient’s right set of at least two adjacent teeth.

[0022] The determination of the height of contour and its use in the design of the MADs is discussed in detail in the aforementioned and above-incorporated ‘327 patent. In some embodiments of the present disclosure, a height of contour of at least one tooth of the at least two adjacent teeth is shorter than the liner lingual wall at a cavity having the inverse shape of the at least one tooth.

[0023] In some embodiments, the dental device liner is made from a different material than the splint of the MAD. In other embodiments, the liner itself is made up of at least two different types of materials. The two materials are selected such that when they are in contact, or when saliva seeps in the space in between them, or when the temperature of the liner reaches above 95 °F, the materials create a voltage potential in between them. This voltage potential can be used to charge the batteries of a sensor or a step motor of the MAD. In some embodiments, when the patient wakes up and discontinues the use of the MAD, the MAD is placed in a cradle, for example to be recharged or cleaned. The cradle then applies a reverse voltage potential to the liners to reverse the chemical reactions that gave rise to the voltage potential in the patient’s mouth. Following the recharging, the two liner materials can then again create the original voltage potential when the MAD is placed in the patient’s mouth.

[0024] The disclosed liners can be made from any material that can withstand the oral environment for an extended period of time, for example overnight. Furthermore, the material can be any material that is capable of being milled to form the devices disclosed herein. Examples of materials include plastics and other polymers, whether hard or soft, transparent or opaque. Some suitable polymers include, but are not limited to, a polyetheretherketone (PEEK), polystyrene, polyvinyl chloride, rubber, synthetic rubber, or an acrylate polymer, such as a polymer made up of methyl methacrylate, methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, or trimethylolpropane triacrylate (TMPTA). In some embodiments, the liner is made of a thermoplastic polymer that decreases its rigidity and/or viscosity in temperatures close to and above the human body temperature (e.g. approximately 95 °F and above), such that the polymer gains some properties of flow with temperature. These materials provide a better fit because the fit can accommodate slight deviations in the anatomy while the entire MAD is supported by the rigid splint. The slight deviations may be those that were accounted for in the digital scan of the patient’ s dentition, or those that developed subsequent to the digital scan, and the like.

[0025] In some embodiments, the liner material is softer than the splint material. The softer liner material provides comfort for the patient, while the harder splint material provides strength and stability to the device.

[0026] As mentioned above, the height ratio is used to adjust the retention of the MAD over the dentition. Similarly, the softness of the liner 180 polymer can be used to affect a better retention. Because the liner 180 polymer is soft, or at least softer than the splint 170 polymer, the liner 180 polymer can better fit around the teeth and provide a greater surface-to-surface contact between the liner 180 and the dentition. A harder, more rigid polymer, for example that used for the splint 170, only contacts the dentition at specific points and cannot reform itself to fully engulf the tooth.

[0027] In some embodiments, the liner buccal wall 110 and the liner lingual wall 112 have certain thicknesses, referred to as the “liner buccal thickness” and the “liner lingual thickness,” respectively. In general, a first liner having a first liner buccal and/or first liner lingual thickness provides a firmer retention than a second liner, having a second liner buccal thickness and/or second liner lingual thickness, when the first liner thickness is greater than the second liner thickness. Additionally, the firmness of the liner 180 can be adjusted by varying the properties of the above-enumerated polymers, as is well-known in the art.

[0028] In some embodiments, the interior bottom 108 of the splint 170 is flat. By “flat” it is meant that the surface is smooth and is not scalloped to form a tooth contour. Thus, a “flat” surface may be wavy, bumpy, corduroyed, lined, and the like, and still fall under the definition of “flat” as long as no tooth contour is present.

[0029] In some embodiments, the interior space of the liner 180 is also flat. In these embodiments, the scalloping 116 is not present.

[0030] In other embodiments, the splint interior bottom is flat, but the interior space of the liner is scalloped. In still other embodiments, both the splint interior and the liner interior are scalloped.

[0031] Several methods are contemplated for holding the liner 180 firmly within the channel 108 of the splint 170 so that during the normal wear and use of the MAD the liner 180 does not fall out. However, the fit should also be loose enough that the user can remove the liner 180 with relative ease from the splint 170 for replacement, cleaning, and the like. In some embodiments, the liner is held in place by friction lock.

[0032] FIGs. 2A shows an embodiment of the locking mechanism to hold the liner 180 in place. In these embodiments, both liner walls 110 and 112 are shorter than their respective device walls 104 and 106. These embodiments include the distal end 202 of the device buccal wall 104 and the distal end 204 of the device lingual wall 106 that are both thicker than the walls 104,106 themselves.

[0033] Throughout the present disclosure, a “distal” point is a position further away from the occlusal surface than a “proximal” point.

[0034] The increased thickness at the distal wall creates a roof 206 below the distal end 202 and a roof 208 below the distal end 204. In some embodiments, the width of the roof 206,208 is the difference between the thickness of the distal ends 202,204 and the thickness of the walls 104,106. In these embodiments, the width of the roof 206 is equal to the thickness of the liner wall 110 at the distal end of the liner wall 110. Similarly, the width of the roof 208 is equal to the thickness of the liner wall 112 at the distal end of the liner wall 110. Thus, the distal end 202 is thicker than the device wall 104 by exactly the thickness of the liner wall 110, and similarly, the distal end 204 is thicker than the device wall 106 by exactly the thickness of the liner wall 112. [0035] In these embodiments, when the liner 180 is placed inside the channel 118, the liner walls 110, 112 snap in place under the roofs created by the distal ends 202,204. To remove the liner 180, one of the liner walls is pushed away from the corresponding device wall such that the liner wall distal end comes free from under the roof and then the liner can be pulled out of the channel 118.

[0036] In some embodiments, such as those depicted in FIG. 2B, the MAD lingual wall 106 is shorter than the liner lingual wall. In some of these embodiments, the MAD lingual wall 106 comprises a protrusion 210 at its distal end. A matching groove 212 is present on the liner buccal wall 112. When the liner 108 is placed inside the channel 118, the protrusion 210 fits within the groove 212, locking the liner in place. In some embodiments, when the distal end of the liner lingual wall 112 is pressed towards the buccal wall 110, the protrusion 210 is freed from the groove 212. In some of these embodiments, the retention mechanism at the buccal wall is as described with respect to FIG. 2A

[0037] In some embodiments, the polymer forming the liner 180 is doped with one or more medications. Once the MAD is placed inside the patient’s mouth, the medication is released per a predetermined rate into the patient’s mouth. In some embodiments, the medication is released when the temperature of the polymer forming the liner 180 reaches above 95 °F. Examples of suitable medications include, but are not limited to, vasodilators, ACE inhibitors, beta blockers, nitroglycerin, anti-plaque formation medications, antidepressants, saliva stimulants, antibiotics, insulin or other diabetes medications, sedatives, or any other medication that seems appropriate for administration to a patient by mouth per a predetermined release rate.

[0038] FIG. 3 shows an exploded view of the splint 170, the liner 180A,180B, and the patient’s dentition 302, as described herein. In the illustrated embodiment, the liner comprises of two non-contiguous segments, one the right (180A) and one on the left (180B) of the jaw.

[0039] The illustrated segments 180A,180B do not cover the incisor region 304 of the dentition. Only the teeth posterior to the canines, i.e., premolars and molars, are covered by the liners 180A,180B. Also, in the illustrated example of FIG. 3, both the liner 180A,180B and the splint 170 are scalloped to feature the inverse shape of the dentition. As discussed above, in some embodiments, only the liner 180A,180B is scalloped and the splint 170 has a flat bottom. [0040] In some embodiments, the inverse image of the dentition imprinted on the liner 180 matches the arrangement of the dentition as they appear in the patient’s mouth. In other embodiments, the inverse image is that of the desired location of the teeth, as determined by a health care profession, such as a physician or a dentist. In these embodiments, the liner 180 affects the orthodontic movement of the teeth towards the desired position. In some embodiments the liner 180 is easily replaced with a new liner 180. The new liner 180 may enable different force profiles on each individual tooth for orthodontic adj u stments .

[0041] In some embodiments, a series of aligning liners are provided that exert different force profiles on each tooth but still fit well into the splint channel, such that the teeth are able to be moved into a desired orthodontic position but the splint is stable, retentive and allows the MAD functionality to still occur.

[0042] In some embodiments, a series of liners adjust the position of the teeth orthodontically. In these embodiments, the final liner in the series is a rigid one or is made up of the same material as the splint, where the hard splint serves as the final retainer in the series of orthodontic adjustments. This allows the patient to have orthodontic treatment while being treated for sleep apnea.

[0043] In some embodiments, the MAD, including the splint 170 and the liner 180, are digitally designed according to a prescription from a health care provider and are automatedly manufactured according to the digital design. Methods of digital design and automated manufacture are described in the above-incorporated publications.

Claims

WHAT IS CLAIMED IS:

1. A dental device liner for use with a patient’s teeth, the patient having a mandible and a maxilla, each of the mandible and maxilla being arch-shaped, the component comprising: at least one segment having a liner buccal wall, a liner lingual wall, and at least two cavities; the segment having the length of at least two adjacent teeth of the patient; each cavity having the inverse shape of one of the at least two adjacent teeth; wherein the component is configured to fit within a channel of a splint of a mandibular advancement device (MAD), the channel having a floor and two side walls, the side walls being an MAD buccal wall and an MAD lingual wall; wherein when the liner is placed within the channel, the liner buccal wall abuts the MAD buccal wall and the liner lingual wall abuts the MAD lingual wall; wherein the liner is digitally designed according to a prescription from a health care provider; wherein the liner is automatedly manufactured according to the digital design.

2. The dental device liner of claim 1, wherein the length of each of the at least two adjacent teeth is measured along the arch of the mandible or maxilla of the patient.

3. The dental device liner of claim 1, wherein a higher ratio of height of exposed liner to height of the MAD lingual wall provides a better retention than a lower ratio of height of exposed liner to height of the MAD lingual wall

4. The dental device liner of claim 1, wherein the at least one of the two adjacent teeth is a molar, a premolar, a canine, or an incisor.

5. The dental device liner of claim 1, wherein the liner comprises two disconnected segments.

6. The dental device liner of claim 6, wherein one of the two disconnected segments is configured to be placed over the patient’s left set of at least two adjacent teeth, and another of the two disconnected segments is configured to be placed over the patient’s right set of at least two adjacent teeth.

7. The dental device liner of claim 1, wherein the segment is configured to be placed over the patient’s entire upper dentition or over the patient’s entire lower dentition.

8. The dental device liner of claim 1, wherein a height of contour of at least one tooth of the at least two adjacent teeth is shorter than the liner lingual wall at a cavity having the inverse shape of the at least one tooth.

9. The dental device liner of claim 1, wherein the liner is made from a different material than the splint of the MAD.

10. The dental device liner of claim 9, wherein the liner material is softer than the splint material.

11. The dental device liner of claim 1, wherein the liner comprises a lingual thickness at liner lingual wall defining the lingual side of a cavity; and a buccal thickness at liner lingual wall defining the buccal side of a cavity.

12. The dental device liner of claim 1, wherein a first liner, having a first thickness and configured to use with a first splint, has a firmer retention than a second liner, having a second thickness and configured to use with a first splint, when the first thickness is thicker than the second thickness.

13. The dental device liner of claim 1, wherein to match the contour of the patient’s teeth: i) the channel floor is flat, but the liner is contoured; or ii) both the channel floor and the liner are contoured.

14. The dental device liner of claim 1, wherein the MAD lingual wall is shorter than the liner lingual wall, the MAD lingual wall having a protrusion at its distal end, the protrusion having a matching groove, wherein when the liner is placed inside the channel, the protrusion fits within the groove, whereby the liner is locked in place.

15. The dental device liner of claim 14, wherein when the distal end of the liner lingual wall is pressed towards the buccal wall, the protrusion is freed from the groove.

16. The dental device liner of claim 1, wherein: i) the MAD lingual wall is longer than the liner lingual wall, ii) the MAD lingual wall comprises a protrusion at its distal end, iii) the protrusion comprises a bottom side facing the channel, iv) the distal end of the liner lingual wall comprises a top side facing away from the channel, wherein when the liner is placed in the channel, the liner lingual wall distal end top side abuts the MAD lingual wall distal end protrusion bottom side .

17. The dental device liner of claim 1, wherein the liner body is made of a first polymer and the MAD body is made of a second polymer.

18. The dental device liner of claim 17, wherein the first polymer is softer than the second polymer such that the second polymer provides strength to the device while the first polymer provides comfort for the patient.

19 The dental device liner of claim 1, wherein the first polymer comprises medications that are released per a predetermined rate into the patient’ s mouth when the liner is worn by the patient.

20. The dental device liner of claim 19, wherein the medication is released when the first polymer temperature reaches above 95 °F.

21. A method of treating sleep apnea while providing simultaneous orthodontic treatment, the method comprising the steps of: identifying a patient in need of such treatment; providing the patient with a set of MAD splints; providing the patient with a series of dental device liners of claim 1, wherein: a first liner is provided to move the patient’ s teeth to a first desired orthodontic position; the next liner in the series moves the patient’s teeth to a new desired orthodontic position; the final liner in the series is a rigid liner, that acts as a retainer, and does not move the patient’s teeth.