WO2017127865A1 - Mandibular splint - Google Patents

Abstract

A mandibular splint (10) adapted to be worn in a mouth of a person. The mandibular splint comprising a lower jaw brace (3) including right and left lower anchor members (20, 30). The right lower anchor member being configured in use to engage at least one of the right lower molars or premolars of the mouth for substantial securement thereto. The left lower anchor member being configured in use to engage at l east one of the left lower molars or premolars of the mouth for substantial securement thereto. An upper jaw brace (4) including right and left upper anchor members (40, 50). The right upper anchor member being configured in use to engage at least one of the right upper molars or premolars of the mouth for substantial securement thereto. The left upper anchor member being configured in use to engage at least one of the left upper molars or premolars of the mouth for substantial securement thereto. The right lower anchor member is spaced from the right upper anchor member in a direction towards a front of the mouth in use. The left lower anchor member is spaced from the left upper anchor member in a direction towards the front of the mouth in use so that a person's lower jaw is displaced from an upper jaw.

Description

MANDIBULAR SPLINT

Field

[0001] The present invention relates to an oral device to treat obstructive sleep apnoea (OSA), snoring or the like. In particular, the present invention relates to a mandibular splint (MS).

Background

[0002] OSA is a sleeping disorder that is caused by the obstruction of the upper part of the airway by the soft tissue and muscles in one's mouth. A person with this disorder might suffer from daytime sleepiness, lack of concentration, snoring or the like.

[0003] One treatment of OSA is the use of a MS, also known as a mandibular advancement splint (MAS), which is worn in one's mouth (typically at night) to urge the lower jaw forward and thereby inhibit the soft throat tissue from collapsing and obstructing the upper airway. That is, the MS tightens the soft tissue and muscles of the upper airway. This form of treatment is often preferred by persons suffering from OSA as it is non-invasive, painless and the treatment is reversible.

[0004] However, a disadvantage of existing mandibular splints is that they engage most or all of the upper and lower teeth and gums during use and thereby cause discomfort. Another disadvantage of existing mandibular splints is that they are quite difficult to manufacture in an efficient and cost effective manner. Further, existing mandibular splints cause the patient to drool and inhibit swallowing properly. Many mandibular splints also place pressure on the incisor teeth (located at the front of the mouth) that may cause bite and jaw issues.

[0005] Accordingly, there is a need for a better mandibular splint that is simple and easy to use, comfortable to wear, cost effective to manufacture and that does not include many parts and the requirement for continual adjustment. Object of the Invention

[0006] It is the object of the present invention to substantially overcome or ameliorate one or more of the disadvantages of the prior art, or at least provide a useful alternative.

Summary of the Invention

[0007] There is disclosed herein a mandibular splint adapted to be worn in a mouth of a person, the mandibular splint comprising:

a lower jaw brace including right and left lower anchor members, the right lower anchor member being configured in use to engage at least one of the right lower molars or premolars of the mouth for substantial securement thereto, the left lower anchor member being configured in use to engage at least one of the left lower molars or premolars of the mouth for substantial securement thereto;

an upper jaw brace including ri ght and left upper anchor members, the right upper anchor member being configured in use to engage at least one of the right upper molars or premolars of the mouth for substantial securement thereto, the left upper anchor member being configured in use to engage at least one of the left upper molars or premolars of the mouth for substantial securement thereto;

wherein the right lower anchor member is spaced from the right upper anchor member in a direction towards a front of the mouth in use, and wherein the left lower anchor member is spaced from the left upper anchor member in a direction towards the front of the mouth in use so that a person's lower jaw is displaced from an upper jaw.

[0008] Preferably, the right upper anchor member is adapted to receive an impression of the at least one of the right upper molars or premolars such that the at least one of the right upper molars or premolars is fittingly receivable therein.

[0009] Preferably, the left upper anchor member is adapted to receive an impression of the at least one of the left upper molars or premolars such that the at least one of the left upper molars or premolars is fittingly receivable therein. [0010] Preferably, the right lower anchor member is adapted to receive an impression of the at least one of the right l ower molars or premolars such that the at least one of the right lower molars or premolars is fittingly receivable therein.

[0011 ] Preferably, the left lower anchor member is adapted to receive an impression of the at least one of the left lower molars or premolars such that the at least one of the left lower molars or premolars is fittingly receivable therein.

[0012] Preferably, the upper jaw brace further includes an upper bridge member connecting the right upper anchor member to the left upper anchor member, the upper bridge member being configured in use to substantially abut with at least the upper incisors of the person.

[0013] Preferably, the lower jaw brace further includes a lower bridge member connecting the right lower anchor member to the left lower anchor member, the lower bridge member being configured in use to substanti ally abut with at least the l ower incisors of the person.

[0014] Preferably, the right upper anchor member is attachable to the right lower anchor member by a right displacement member.

[0015] Preferably, the left upper anchor member is attachable to the left lower anchor member by a left displacement member.

[0016] Preferably, the right and left upper anchor members are fixedly attached to the right and left lower anchor members, respectively.

[0017] Preferably, the right and left upper anchor members are releasably attachable to the right and left lower anchor members, respectively.

[0018] Preferably, the displacement member includes a hinge mechanism.

[0019] Preferably, the anchor members are snap-lockingly engageable with the respective molars and/or premolars. [0020] Preferably, the splint includes adjustraent means to permit incremental adjustment of the upper and lower anchor members relative to each other.

[0021] Preferably, including multiple tooth inserts to permit incremental advancement of the upper and lower anchor members.

[0022] There is disclosed herein a kit comprising:

at least two mandibular splints, each mandibular splint according to the above, wherein, in a first of the mandibular splints, the right and left lower anchor members are spaced from the right and left upper anchor members, respectively, by a first predetermined distance, and in a second of the mandibular splints, the right and left lower anchor members are spaced from the right and left upper anchor members, respectively, by a second predetennined distance, the first predetermined distance being different to the second predetennined distance.

[0023] Preferably, the difference between the first and second predetermined distances is about 4 to 7 mm.

[0024] There is also disclosed herein a method of manufacturing a mandibular splint according to the above, the method comprising:

scanning at least the upper and lower molars or premolars of a person to produce a three- dimensional image of that person's molars or premolars;

printing a three-dimensional cast of the three-dimensional image; and

moulding the mandibular splint from the three-dimensional cast.

[0025] Preferably, the mandibular splint is moulded from a plastic material. Brief Description of Drawings

[0026] A preferred embodiment of the invention will be described hereinafter, by way of example only, with reference to the accompanying drawings, wherein:

[0027] Figure 1 is a top perspective view of a mandibular splint according to one embodiment of the present invention; [0028] Figure 2 is a top perspective view of the mandibular splint of Figure 1 with an upper bridge member unconnected and anchor members upside down;

[0029] Figure 3 is a parts exploded view of an embodiment of the present invention;

[0030] Figure 4 shows the parts exploded in Figure 3 connected together;

[0031 ] Figures 5a and 5b shows an alternate embodiment of the present invention from a side and front view;

[0032] Figures 6a and 6b shows an alternate embodiment of the present invention from a side and front view;

[0033] Figures 7a and 7b shows an alternate embodiment of the present invention from a side and front view;

[0034] Figures 8a and 8b shows an alternate embodiment of the present invention from a side and front view;

[0035] Figures 9a and 9b shows a parts exploded views of Figures 8a and 8b;

[0036] Figures 10a and 10b shows an alternate embodiment of the present invention from a side and front view;

[0037] Figures 1 l a to l i d show parts exploded views of Figures 10a and 10b;

[0038] Figures 12a and 12b shows an alternate embodiment of the present invention from a side and front view;

[0039] Figures 13a to 13d are parts exploded views of Figures 12a and 12b;

[0040] Figures 14a to 14b are parts exploded views of a further embodiment of the present invention; [0041] Figures 15a to 15c show the advancement of the lower portion of an embodiment of the present invention;

[0042] Figures 16a to 16c shows the advancement of the tooth insert of an embodiment of the present invention; and

[0043] Figures 17a to 17c show incremental adjustment of tooth inserts. Description of Embodiments

[0044] Figures 1 and 2 illustrate a first embodiment of a mandibular splint 10 of the present invention adapted to be worn in a mouth (not shown) of a person (not shown). The mandibular splint 10 comprises a lower jaw brace 3 and an upper jaw brace 4. The lower jaw brace includes right 20 and left 30 lower anchor members. The right lower anchor member 20 has a periphery that is slightly larger than that of any one of the right lower posterior teeth (e.g. premolars and molars) of the mouth and is fabricated with an impression 21 of two right lower molars or premolars imprinted on its bottom surface. n use, the right lower anchor member 20 is configured to engage the two right lower molars or premolars by fittingly receiving the two right lower molars or premolars within the impression 21 such that the right lower anchor member 20 is secured thereto. In the preferred form, the fit would be a snap fitting engagement. That is, a complete locking engagement. Similarly, the left lower anchor member 30 has a periphery that is slightly larger than that of any one of the left lower posterior teeth (e.g. premolars and molars) of the mouth and is fabricated with an impression 31 of one left lower molar or premolar of the mouth imprinted on its bottom surface. In use, the left lower anchor member 30 is configured to engage the left lower molar or premolar by fittingly receiving the left lower molar or premolar within the impression 21 such that the left lower anchor member 20 is secured thereto. As mentioned above, a snap fitting engagement is desirable.

[0045] Although the impressions 21 , 31 are of two right molars or premolars and one left molar or premolar, respectively, it will be appreciated that the impressions 21 , 31 may be of any one or more of the molars or premolars or the like.

[0046] As with the above, the upper jaw brace includes right 40 and left 50 upper anchor members. The right upper anchor member 40 has a periphery that is slightly larger than that of any one of the right upper posterior teeth (e.g. premolars and molars) of the mouth and is fabricated with an impression 41 of two right upper molars or premolars imprinted on a top surface. In use, the right upper anchor member 40 is configured to engage two right upper molars or premolars by fittingly receiving the two right upper molars or premolars within the impression 41 such that the right upper anchor member 40 is secured thereto. In a preferred form, the fit will be a snap fitting engagement as discussed above. The left upper anchor member 50 has a periphery that is slightly larger than that of any one of the left upper posterior teeth (e.g. premolars and molars) of the mouth and is fabricated with an impression 51 of two left upper molars or premolars of the mouth imprinted on its top surface. In use, the left upper anchor member 50 is configured to engage the two left upper molars or premolars by fittingly receiving the two left upper molars or premolars within the impression 51 such that the left upper anchor member 50 is secured thereto. In a preferred form the fit will be a snap fitting engagement as discussed above.

[0047] Although the impressions 41 , 51 are of two right molars or premolars and one left molar or premolar, respectively, it will be appreciated that the impression 41 may be of any one or more of the right upper posterior teeth and the impression 51 may be of any one or more of the left upper posterior teeth.

[0048] The mandibular splint 10 further comprises right 60 and left 70 displacement members. The right 60 and left 70 displacement members are substantially the same length in a preferred form. For persons with misaligned jaws they may be set at different lengths. The right displacement member 60 fixedly attaches the right lower anchor member 20 to the right upper anchor member 40 such that, in use, the right lower anchor member 20 is laterally spaced from the right upper anchor member 40 in a direction towards a front of the mouth (that is, towards the incisors). The right displacement member 60 extends from an interior side 22 of the right lower anchor member 20 to an interior side 42 of the right upper anchor member 40. This extension arrangement at least minimises the risk of the right displacement member 60 from causing discomfort to the person during use of the mandibular splint 10. Similarly, the left displacement member 70 fixedly attaches the left lower anchor member 30 to the left upper anchor member 50 such that, in use, the left lower anchor member 30 is laterally spaced from the left upper anchor member 50 in a direction towards a front of the mouth (i.e. towards the incisors). The left displacement member 70 extends from an interior side 32 of the left lower anchor member 30 to an interior side 52 of the left upper anchor member 50. This extension arrangement allows the left displacement member 70 to be located towards the interior of the mouth (i.e. away from the wall of the mouth) for comfort of the person during use. The displacement members 60, 70 in one form could include a hinge mechanism. The displacement members 60, 70 could be a separate piece, integrally formed, solid or flexible.

[0049] The upper jaw brace further includes an upper bridge member 80 connecting the right upper anchor member 40 to the left upper anchor member 50. The upper bridge member 80 substantially corresponds to the shape of the maxillary arch such that the upper bridge member 80 substantially abuts with the outer surface of the upper anterior teeth in use. The upper bridge member 80 allows the person to easily manoeuvre the anchor members 20, 30, 40, 50 into the correct location to receive the respective upper molars or premolars. Further, the upper bridge member 80 allows the mandibular splint 10 to be an integral unit (if desired) to prevent individual parts (i.e. the anchor member 20, 30, 40, 50) to form a choking hazard. The upper bridge member 80 also makes the mandibular splint 10 more attractive to use as it does not push the lips of a user out away from the incisors.

[0050] An exemplary use of the mandibular splint 10 will now be described. The mandibular splint 10 is inserted into the mouth of the person. The person will hold the mandibular splint 10 by the upper bridge member 80. Once inserted, the person will manoeuvre the mandibular splint 10 by the upper bridge member 80 until the respective molars or premolars are located and received into the impressions 21, 31, 41 , 51 such that the anchor members 20, 30, 40, 50 are secured. As the right 60 and left 70 displacement members space the right 20 and left 30 lower anchor members in the direction towards the front of the mouth (i.e. the incisors), the lower jaw is consequently displaced from the upper ja w in the same direction. This displacement of the lower jaw inhibits the soft throat tissue and/or muscles from collapsing and obstructing the upper airway causing OSA, snoring or the like. The distance of the displacement can be varied or set by the user or health professional as discussed later.

[0051] In other embodiments, the right 40 and left 50 upper anchor members may be releasably attached to the right 20 and left 30 lower anchor members, respectively. For example, the right upper anchor member 40 and the right lower anchor member 20 may be attached by a releasable mechanism. Various other attachment mechanisms could be utilised as shown in the figures attached. [0052] In other embodiments, the lower jaw brace may include a lower bridge member connecting the right lower anchor member 20 to the left lower anchor member 30. The lower bridge member 80 would be configured in use to substantially abut the inside or outside surface of the lower anterior teeth.

[0053] Figures 3 and 4 show an alternate embodiment of the present invention where the right and left anchor members 20, 30, 40, 50 are separated from the bridge member 80 and are connected together prior to use. As can be seen from the figures this would include the use of a slot 100 on the bridging member 80 to receive a protrusion (not shown) located on the anchor members 20, 30, 40, 50 and preferably on the right upper anchor member 40 and the left anchor member 50. A plate 102 could also be located attached to that protrusion or from the right upper anchor member 40 or left upper anchor member 50 and receivable by the bridge member 80 to hide the slot 100.

[0054] In Figures 5 a, 5b, 6a, 6b, 7a, 7b, 8a and 8b alternate embodiments of the mandibular splints 10 are shown. In each of these embodiments different configurations show different types of mechanisms to contact the lower jaw brace 3 with the upper jaw brace 4. For example, a series of slot and key connections 1 10 could be utilized.

[0055] In particular, in Figures 8a, 8b, 9a, 9b a further embodiment of the mandibular splint 10 is shown where the attachment between the lower jaw brace 3 and the upper jaw brace 4 is by connection of a protrusion 1 12 and apertures 1 14.

[0056] In Figures 10a, 10b the connection is by a protrusion 1 16 and a plate 1 18 having an aperture 120. This is better seen in parts exploded views Figures 1 1 a to 1 Id. The aperture 120, plate 1 18 and protrusion 1 16 can be of any shape or size so long as they provide a corresponding fit. The fit could be an interference fit, snap locking fit or they could be fitted together and then sealed closed.

[0057] In the embodiment shown in Figures 12a, 12b, 13a to 13d the connection 1 10 is shown as a slot 120 and tongue 121. Again the slot 120 and tongue 121 can be of any shape or size so long as there is a corresponding fit as discussed above.

[0058] In Figures 14a and 14b a further embodiment of the present invention are shown. [0059] In Figures 15a to 15c a method of advancement of the entire lower portion is shown. The lower portion 3 is tooled as an insert which can move forwards and backwards

incrementally to allow for a range of advancements to be moulded via a simple adjustment.

[0060] In Figures 16a to 16c an enlarged, extended tooth insert that covers the entire range of advancement is shown. Positioning of the insert is then able to be adjusted in-mould to achieve the desired advancement distance.

[0061] In Figures 17a to 17c multiple tooth inserts are shown. The multiple tooth inserts are produced to cover an entire advancement range allowing for incremental adjustment. This will be actioned at the CAD procurement stage, removing need for complex, adjustable tooling configurations.

[0062] It is envisioned that a kit comprising at least two of the mandibular splints 10 described above would be provided to allow varying displacements of the lower jaw. For example, the kit may comprise five to ten mandibular splints 10 for example. Each of the mandibular splints 10 would have right 20 and left 30 lower anchor members that are spaced from the right 40 and left 50 upper anchor members, respectively, by varying distances within a range of 1 to 12 mm and in a preferred embodiment 4 to 7 mm. However, any conceivable range could be utilized depending upon a user's mouth size and symptoms being treated. The kit would allow the person to select the correct displacement of the lower jaw he/she desires and/or incrementally increase the displacement of the lower jaw over time.

[0063] In a preferred form, the anchor members 20, 30, 40, 50 of the mandibular splint 10 would be manufactured utilising the method described hereinbelow.

[0064] Step 1 : The teeth of a person are scanned to produce a three-dimensional image. For example, a CT or CAT scanning machine could be utilised.

[0065] Step 2: A three-dimensional printer prints a cast of the teeth based on the three- dimensional image.

[0066] Step 3: The anchor members 20, 30, 40, 50 would be injection moulded from the cast produced in step 2 above to at least form the impressions 21 , 31, 41 , 51 discussed previously. [0067] All components of the mandibular splint 10 would be manufactured from a medical grade plastic or the like.

[0068] It will be apparent to those skilled in the art that the mandibular splint 10 of a preferred embodiment secures to the posterior teeth of the person such that the mandibular splint 10 is less obtrusive and does not damage the gums of the person. It allows the person to swallow while using the mandibular splint 10. It is relatively quick and cost effective to manufacture and use.

[0069] The mandibular splint 10 could also include a number of significant advancements to the monitoring of a patient for OSA, snoring or the like. For example, one or more holes or apertures (not shown) creating an audible noise or whistle from the user's breath could be located in the splint 10 to provide feedback. One or more monitoring or recording devices could be located in or on the mandibular splint 10 to assist a user or medical staff in monitoring a patient. Also, a hinged flap or the like could be utilised connecting to a monitoring device or switch to assist with determining the effectiveness of the mandibular splint 10 and record air flow through the mouth. That is, there could be a hinge mechanism and there could be airflow and/or acoustic measurement of the efficiency of the splint 10.

[0070] Although the invention has been described with reference to preferred embodiments, it will be appreciated by a person skilled in the art that the invention may be embodied in many other forms.

Claims

1. A mandibular splint adapted to be worn in a mouth of a person, the mandibular splint comprising:

a lower jaw brace including right and left lower anchor members, the right lower anchor member being configured in use to engage at least one of the right lower molars or premolars of the mouth for substantial securement thereto, the left lower anchor member being configured in use to engage at least one of the left lower molars or premolars of the mouth for substantial securement thereto;

an upper jaw brace including right and left upper anchor members, the right upper anchor member being configured in use to engage at least one of the right upper molars or premolars of the mouth for substantial securement thereto, the left upper anchor member being configured in use to engage at least one of the left upper molars or premolars of the mouth for substantial securement thereto;

wherein the right lower anchor member is spaced from the right upper anchor member in a direction towards a front of the mouth in use, and wherein the left lower anchor member is spaced from the left upper anchor member in a direction towards the front of the mouth in use so that a person's lower jaw is displaced from an upper jaw.

2. The mandibular splint according to claim 1, wherein the right upper anchor member is adapted to receive an impression of the at least one of the right upper molars or premolars such that the at least one of the right upper molars or premolars is fittingly recei vable therein.

3. The mandibular splint according to claim 1 , wherein the left upper anchor member is adapted to receive an impression of the at least one of the left upper molars or premolars such that the at least one of the left upper molars or premolars is fittingly receivable therein.

4. The mandibular splint according to claim 1, wherein the right lower anchor member is adapted to receive an impression of the at least one of the right lower molars or premolars such that the at least one of the right lower molars or premolars is fittingly receivable therein.

5. The mandibular splint according to claim 1 , wherein the left lower anchor member is adapted to receive an impression of the at least one of the left lower molars or premolars such that the at least one of the left lower molars or premolars is fittingly receivable therein.

6. The mandibular splint according to claim 1, wherein the upper jaw brace further includes an upper bridge member connecting the right upper anchor member to the left upper anchor member, the upper bridge member being configured in use to substantially abut with at least the upper incisors of the person.

7. The mandibular splint according to claim 1, wherein the lower jaw brace further includes a lower bridge member connecting the right lower anchor member to the left lower anchor member, the lower bridge member being configured in use to substantially abut with at least the lower incisors of the person.

8. The mandibular splint according to claim 1, wherein the right upper anchor member is attachable to the right lower anchor member by a right displacement member.

9. The mandibular splint according to claim 1, wherein the left upper anchor member is attachable to the left lower anchor member by a left displacement member.

10. The mandibular splint according to claim 1 , wherein the right and left upper anchor members are fixedly attached to the right and left lower anchor members, respectively.

11. The mandibular splint according to claim 1 , wherein the right and left upper anchor members are releasably attachable to the right and left lower anchor members, respectively.

12. The mandibular splint according to claim 8 or 9, wherein the displacement member includes a hinge mechanism.

13. The mandibular splint according to claim 1 , wherein the anchor members are snap- lockingly engageable with the respective molars and/or premolars.

14. The mandibular splint according to claim 1 , wherein the splint includes adjustment means to permit incremental adjustment of the upper and lower anchor members relative to each other.

15. The mandibular splint according to claim 1 , including multiple tooth inserts to permit incremental advancement of the upper and lower anchor members.

16. A kit comprising:

at least two mandibular splints, each mandibular splint according to the above, wherein, in a first of the mandibular splints, the right and left lower anchor members are spaced from the right and left upper anchor members, respectively, by a first predetermined distance, and in a second of the mandibular splints, the right and left lower anchor members are spaced from the right and left upper anchor members, respectively, by a second predetermined distance, the first predetermined distance being different to the second predetermined distance.

17. The kit according to claim 1, wherein the difference between the first and second predetermined distances is about 4 to 7 mm.

18. A method of manufacturing a mandibular splint according to the above, the method comprising:

scanning at least the upper and lower molars or premolars of a person to produce a three- dimensional image of that person's molars or premolars;

printing a three-dimensional cast of the three-dimensional image; and

moulding the mandibular splint from the three-dimensional cast.

19. The method according to claim 18, wherein the mandibular splint is moulded from a plastic material.