WO2014197430A1 - Elastic pull oral appliance and methods of treating sleep apnea and snoring while concurrently preventing or reducing the risk of tmj - Google Patents

Abstract

An elastic pull oral appliance for treating sleep apnea and snoring while concurrently preventing or reducing the. risk of TMJ disorder. The appliance includes a bite pad providing therapeutic treatment. The bite pad has a durometer hardness in the range of 10 Shore A to 100 Shore A. The appliance further includes an elastic elongate member integral to the bite pad. The elongate member also has a durometer hardness in the range of 10 Shore A to 100 Shore A. Other components may also be included in the appliance such as anchors and attachment structures for releasable attachment to maxilllary and mandibular trays formed in accordance to the human patient's jaw and teeth.

Description

ELASTIC PULL ORAL APPLIANCE AND METHODS OF TREATING SLEEP APNEA AND SNORING WHILE CONCURRENTLY PREVENTING OR REDUCING THE RISK OF TMJ

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Patent Application No.

61/830,755 filed on June 4, 2013 entitled ELASTICLY ADJUSTABLE MANDIBULAR APPLIANCE AND METHOD OF TREATING SLEEP APNEA AND SNORING AND PREVENTING OR REDUCING THE RISK OF SIDE EFFECTS THEREOF, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The technology herein generally relates to oral appliances for treating, preventing or alleviating snoring and sleep apnea while avoiding or reducing the risk of temporomandibular disorders (TMD) occurring in the temporomandibular joint (TMJ). The technology herein relates to removable mandibular advancement appliances having structures adapted to move the jaw forward and to move the mandible away from the skull, thus opening the bite vertical.

BACKGROUND

[0003] It is documented in the medical and scientific literature that removable oral appliances are useful by advancing the mandible forward to treat sleep apnea and snoring in humans. However, many oral appliances create one or more of the following, considerable tooth pain , undesirable tooth movement, temporomandibular joint pain, and other side effects.

[0004] Permanent irreversible modifications of the appliance is achieved by incorporating soldered spacers or grinding away material. While such modifications adjust the mandible to a new fixed position, the appliance has been structurally altered, which is undesirable.

[0005] Undesirable side effects also exist in the oral appliance art. Patient acceptance and compliance has been problematic due to discomfort and appliance bulk. Other undesirable side effects include temporomandibular joint problems, unwanted tooth movement and soreness.

[0006] There also exists a need to conveniently and periodically adjust the advancement of mandible and adjust bite plane height to maintain efficacy of the appliance and prevent (or reduce the risk of) side effects. It is desirable that a doctor or patient could perform such periodic adjustments in a convenient and simple manner, thus customizing a treatment regimen for the patient to improve patient acceptance, effectiveness, and compliance.

SUMMARY

[0007] One aspect of the invention is an pull oral appliance for treating sleep apnea and snoring while concurrently preventing or reducing the risk of TMJ disorder including an elastic bite pad providing therapeutic treatment, and an elastic elongate member integral to the bite pad.

[0008] In one embodiment of the oral applicace, the bite pad and elongate member have a durometer hardness in the range of 10 Shore A to 100 Shore A.

[0009] In another embodiment of the pull oral appliance, it further includes a maxillary attachment member integral to the elongate member, and, a mandibular attachment member integral to the bite pad.

[0010] In another embodiment of the pull oral appliance, the bite pad, elongate member, maxillary attachment member and mandibular attachment member are constructed from an elastic material, and, wherein the maxillary attachment member and mandibular attachment member are constructed from a non-elastic material.

[0011] In another embodiment of the pull oral appliance, the bite pad, elongate member, maxillary attachment member and mandibular attachment member are constructed from either Dynaflex by GLS Corporation or Pellethane 2363 Polyurethane by Dow Chemical of various durometers.

[0012] In another embodiment of the pull appliance, it further includes a maxillary anchor adapted to releasably attach to the maxillary attachment member, and a mandibular anchor adapted to releasably attach to the mandibular attachment member. [0013] In another embodiment of the pull appliance, it further includes maxillary and mandibular trays, the maxillary anchor is affixed to the maxillary tray, and the mandibular anchor is affixed to the mandibular tray.

[0014] In another embodiment of the pull oral appliance, the height of said bite pad is in the range of 3mm to 18mm.

[0015] In another embodiment of the pull oral appliance, the width of the elongate member is in the range of 3mm to 8mm.

[0016] In another embodiment of the pull oral appliance, it further includes maxillary attachment means integral to the elongate member, and, mandibular attachment means integral to the bite pad.

[0017] In another embodiment of the pull oral appliance, it further includes maxillary anchoring means affixed to an upper tray for releasable attachment to the maxillary attachment means, and, mandibular anchoring means affixed to a lower tray for releasable attachment to the mandibular attachment means.

[0018] Another aspect of the invention is a method of treating obstructive sleep apnea and snoring in a human using any of the pull oral appliances above using the steps or acts of (in any order) preventing a jaw from retracting, deflecting mandibular

advancement, and, preventing or reducing the risk of temporomandibular joint disorders.

[0019] In one embodiment of the method, it further includes preventing or reducing the risk of side effects selected from discomfort, tooth soreness, and tooth movement.

[0020] In another embodiment of the method, it further includes vertically adjusting the jaw in the range of 3mm to 19mm in the anterior region as measured from an upper right central incisor where it meets an upper gingival tooth line to a lower right central gingival tooth line.

[0021] In another embodiment of the the method, it further includes forward adjusting the jaw in the range of 2mm to 20 mm as measured from a predetermined centric occlusion.

[0022] In another embodiment of the method, it further includes a plurality of steps of vertically and forwardly adjusting the jaw various lengths for a duration of time.

[0023] In another embodiment of the method, it further includes a plurality of steps of variously deflecting mandibular advancement. [0024] The summary includes a recitation of the claims in ordinary language to provide literal support which is needed in US applications and particularly foreign patent applications.

[0025] It is well documented that repositioning the mandible with a removable oral appliance is an effective means of treating both snoring and sleep apnea. The present invention enables a physician or dentist to select the desired amount of mandibular advancement and to select the desired amount of vertical opening to provide successful treatment.. Multiple appliances of varying durometer hardness and dimensions are employed to optimize therapeutic treatment (e.g., vertical displacement and mandibular advancement) for effective treatment. While in use, the appliance frees the mandibular forward as well as lateral excursion whereby one end of the appliance is removably attached to the maxillary tray in the anterior, and the other end of the appliance is removably attached the mandibular tray in the posterior.

[0026] In theory, the bite pad of the elastic component of the appliance is compressed between maxillary and mandibular teeth under muscular force. In response to that compression, the inelastic components effectively pulls the mandibular forward. The elastic and inelastic components are interchangeable/replaceable with other elastic components having different hardness/durometer, dimensions, etc. to provide variable amounts of therapeutic mandibular advancement and vertical mandibular deflections. As the patient goes into REM sleep, they become essentially paralyzed. As the mandible jaw is advanced, the tongue is pulled forward as it is attached to the mandible, thus opening the airway. Elastics, while effectively advancing the mandible (and opening the bite), cushion the patients TMJ (and the appliance). For those patients who obstruct in the base of the epiglottis/tip of the epiglottis (hypopharynx) region, advancing the mandible is therapeutic. For those patients that obstruct in the soft palate/uvula (velopharynx) region, opening the bite vertically is also very therapeutic.

[0027] The foregoing is a summary and thus contains, by necessity, simplifications, generalizations and omissions of detail. Consequently, those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, features, and advantages of the devices and/or processes and/or other subject described herein will become apparent in the text set forth herein. [0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] A better understanding of the subject matter of the present application is apprehended in view of the detailed description of the following disclosed embodiments considered in conjunction with the following drawings.

[0030] Figure 1 shows an upper side perspective view of one aspect of the invention depicting one embodiment of the pull dental appliance removably applied to plaster or stone dental fixtures for treating sleep apnea or snoring while concurrently preventing or reducing the risk of TM J.

[0031] Figure 2 shows a side perspective view of another embodiment of the pull dental appliance for treating sleep apnea or snoring while concurrently preventing or reducing the risk of TM J.

[0032] Figure 3 shows a side perspective view of the pull dental appliance depicted in Figure 2.

DETAILED DESCRIPTION

[0033] Those of skill in the dental appliance arts will recognize that the disclosed embodiments have relevance to a wide variety of applications and architectures in addition to those described below. In addition, the functionality of the subject matter of the present application can be implemented in other apparent applications.

[0034] Shown in Fig. 1 is one embodiment of the pull oral dental appliance 100 releasably applied to a maxillary (i.e., upper) and mandibular (i.e., lower) dental model architectures 12,14 preferably constructed from plaster or stone or another suitable material. In this embodiment, the appliance 100 includes maxillary (i.e., upper) and mandibular (i.e., lower) trays 16,18, preferably constructed from polyethylene terepthlate (PETB) or like material using thermo-pressure forming processes Eastman Eastar PETG Copolymer 6763.

[0035] As shown in Figures 1, 2, and 3, another embodiment of a releasably attachable pull dental appliance 200 is releasably attached to the trays 16,18, which may be made from Eastman Eastar PETG Copolyester 6763. The appliance includes anchors 26,32 (preferably constructed from PETG or a like material) affixed to the trays 16,18 using an adhesive material, such as acrylic adhesive (e.g., cold cure orthodontic acrylic) or another suitable adhesive. [0036] Maxillary anchor 32,34 are affixed to upper tray 16 being located on each anterior labial portion of the upper tray near the upper cuspid teeth. Mandibular anchors 26 are affixed to the posterior buccal portion on each side of the lower tray 18 on the occlusal surface of the lower molar teeth. The maxillary 32,34 and mandibular anchors 22,26 are generally aligned with one another, and the maxillary anchor 32 is forward of the mandibular anchor 26. As in the pull appliance 200 (whereby the attachments are mirror images of each other) anchors 22,26,32,34 are employed in the human patient's maxillary and mandibular jaws, i.e., one on the left side and one on the right side to therapeutically treat the human for sleep apnea and/or snoring while concurrently preventing TMJ.

[0037] The lower or mandibular anchor 26 is a curved catch element that releasably engages an elastic portion 24,27. The upper or maxillary anchor 32 further includes a post or peg 34 (having a stay) for engaging an aperture in an upper attachment member 30. The lower or mandibular anchor 26 also includes a post 22 that releasably engages an aperture in the elastic portion 24.

[0038] Further as shown in Figures 1 and 2, the embodiment includes elastic injection molded component 24,27,28,30 having a bite pad 27. The anterior portion of the elastic strap has a tab 30 having an aperture therein for securing the elongate member to post 34. Moving posterior the elongate member 28 may be of various lengths to provide various millimeters of advancement, then bite pad 27 provides various bite openings being of various thicknesses attached to post 22. An elongate member 28 may be of various lengths to provide different millimeters of advancements of the mandible and upper attachment member 30. Post 30 may also have a hole to hook over post 34.

[0039] The hardness of the elastic injection molded component is preferably in the range of 10 Shore A to 100 Shore A and constructed from either Dynaflex available from GLS Corporation or Pellethane 2363 Polyurethane available from Dow Chemical. The elongate member 28 may be various shapes, such as a rod or cord (i.e., cylindrical), a band, or other suitable shapes.

[0040] The maxillary attachment means includes anchor 32 and the post 34. The mandibular attachment means includes the anchor 26 and the post 22. Other suitable maxillary and mandibular attachment structures may be employed as is known in the art to releasably attach the elastic straps to the pull dental appliance 200 to the upper and lower trays 16,18.

[0041] Posterior occlusal right and left surfaces of lower tray 18 are provided.

Interchangeable bite pads 27 having a variety of thicknesses are provided to increase or decrease the vertical component of the appliance. The bite planes are provided each having a top side providing a smooth surface engageable with the occlusal surface of the upper tray 16 to space the occlusal surfaces from one another while permitting sliding movement of these surfaces laterally as well as longitudinally relative to one another. The bottom side of each bite plane rests on the right and left surfaces of lower tray being formed for releasable attachment to a side of the lower tray 18 being attached to peg 22.

[0042] The maxillary and mandibular anchors 22,26 on the right and on the left may be bonded to the outer sides of the upper and lower trays 16,18, respectively, with orthodontic acrylic. The anchors 32,34 on the upper or maxillary tray and anchors 26,22 on the posterior part of the lower or mandibular trays are configured and adapted for releasable retention of the elastic members 24,27,28,30. The anchors 32,34 may be disposed as follows: One on the right and one on the left of the anterior labial (check) portion of the maxillary or upper tray 16. One on the right and one on the left of the posterior buccal (cheek) portion of the mandibular or lower tray 18.

[0043] The length of the elastic member 24,27,28,30 may be about 15-30 mm. The length and/or elasticity of the elastic components 24,27,28,30 being such that, when attached to the anchors 32,34 on the upper tray and anchors 26,22 on the lower tray, they are placed in tension or stretched as the appliance 100,200,300 is installed in a patient's mouth so as to urge the lower jaw forward and open the bite. Preferably, the elongate member 28 is about 3-4 mm thick.

[0044] The elastic member 24,27,28,30 is preferably made of injection molded thermoplastic elastomer, of different lengths, different durometers, and different bite pad thicknesses which may be provided to satisfy the patient's needs. The elastic member 24,27,28,30 allows the patient's musculature to relax by the use of a low durometer strap. When treatment is started until the musculature accepts mandibular advancement when firmer straps can be placed without TMJ pain because there is less resistance and not to fight or resist the bias. [0045] The elastic member 24,27,28,30 may be made from various hardness/durometer elastics and releasable attached to the anchors on the lower appliance and on the upper appliance. The elongate member 28 and bite pad 27 provide elastic protection from TMJ. The bite pad 27 may have various vertical heights and made of various durometers. A plurality of bite pads 27 provide a wide range of vertical openings simply by inserting a different elastic strap having a different hardness (i.e., durometer) and/or bite pad thickness/height.

[0046] The bite pad 27 and elongate member 28 regulates and determines the length or amount of mandibular advancement. The pull appliance 24,27,28,30 may be injection molded in various lengths and different durometers providing various lengths of mandibular advancement and firmness of bite pad and firmness of elastic pull.

[0047] Preferably, as regards the bite plane of the bite pad 27, the top surface is at an elevation below the occlusal surface of one side of the tray 16 to provide a vertical opening of anywhere from 3 millimeter to 18 millimeter. There will be identical bite planes on the opposite side of the tray 16. A single bite pad 27 is described in detail below.

[0048] Preferably, the bite pad 27 may be made of injection molded plastic and has a generally smooth, curved, and convex top contact surface. The bite plane of the bite pad 27 has a generally flat bottom surface.

[0049] The component parts 26,22 of the pull appliance 100,200 may be removably attached to the posterior buccal right and left surfaces of the mandibular lower tray 18. When it is desired to remove and replace the bite pad 27 which is a part of the injection molded part 24,27,28,30 with a thicker or thinner bite pad 27, a different elastic pull appliance having different dimensions (and perhaps a different hardness durometer) is simply releasably attached to the anchors 26,22 on the lower and 32,34 on the upper.

Various bite pads 27 provide various therapeutic treatments. For example, a thicker bite pad 27 may be substituted in place of an original bite pad 27 to more efficaciously treat the sleep apnea and/or snoring and still provide for sufficient patient comfort, particularly respecting TMJ.

[0050] At any stage of treatment, this elastic member may, at the discretion of the treating doctor, be replaced with a non-elastic member so the effective treatment mandible location may be guaranteed to remain. If TMJ pain develops, an elastic member may be reinserted.

[0051] While the subject matter of the application has been shown and described with reference to particular embodiments thereof, it will be understood by those skilled in the art that the foregoing and other changes in form and detail may be made therein without departing from the spirit and scope of the subject matter of the application, including but not limited to additional, less or modified elements and/or additional, less or modified steps performed in the same or a different order.

[0052] While particular aspects of the present subject matter described herein have been shown and described, it will be apparent to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from the subject matter described herein and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of this subject matter described herein. Furthermore, it is to be understood that the invention is defined by the appended claims. It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term

"having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to inventions containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations.

Claims

We Claim:

1. A pull oral appliance for treating sleep apnea and snoring while concurrently preventing or reducing the risk of TMJ disorder comprising:

an elastic bite pad providing therapeutic treatment, and

an elastic elongate member integral to the bite pad.

2. The pull oral appliance of claim 1, wherein the wherein the bite pad and elongate member have a durometer hardness in the range of 10 Shore A to 100 Shore A.

3. The pull oral appliance of claim 2, further comprising:

a maxillary attachment member integral to the elongate member, and,

a mandibular attachment member integral to the bite pad.

4. The pull oral appliance of claim 2,

wherein the bite pad, elongate member, maxillary attachment member and mandibular attachment member are constructed from an elastic material, and,

wherein the maxillary attachment member and mandibular attachment member are constructed from a non-elastic material.

5. The pull oral appliance of claim 2, wherein the bite pad, elongate member, maxillary attachment member and mandibular attachment member are constructed from either Dynaflex by GLS Corporation or Pellethane 2363 Polyurethane by Dow Chemical of various durometers.

6. The pull appliance of claim 2, further comprising:

a maxillary anchor adapted to releasably attach to the maxillary attachment member, and, a mandibular anchor adapted to releasably attach to the mandibular attachment member.

7. The pull appliance of claim 2, further comprising:

maxillary and mandibular trays,

wherein the maxillary anchor is affixed to the maxillary tray, and,

wherein the mandibular anchor is affixed to the mandibular tray.

8. The pull oral appliance of claim 2, wherein the height of said bite pad is in the range of 3mm to 18mm.

9. The pull oral appliance of claims 2, wherein said width of said elongate member is in the range of 3mm to 8mm.

10. The pull oral appliance of claim 2, further comprising:

maxillary attachment means integral to the elongate member, and,

mandibular attachment means integral to the bite pad.

11. The pull oral appliance of claim 10, further comprising:

maxillary anchoring means affixed to an upper tray for releasable attachment to the maxillary attachment means, and,

mandibular anchoring means affixed to a lower tray for releasable attachment to the mandibular attachment means.

12. A method of treating obstructive sleep apnea and snoring in a human using the pull oral appliance of claims 1 or 2 comprising the steps in any order of:

preventing a jaw from retracting,

deflecting mandibular advancement, and,

preventing or reducing the risk of temporomandibular joint disorders.

13. The method of claim 12, further comprising preventing or reducing the risk of side effects selected from discomfort, tooth soreness, and tooth movement.

14. The method of claim 12, further comprising:

vertically adjusting the jaw in the range of 3mm to 19mm in the anterior region as measured from an upper right central incisor where it meets an upper gingival tooth line to a lower right central gingival tooth line.

15. The method of claim 12, further comprising:

forward adjusting the jaw in the range of 2mm to 20 mm as measured from a predetermined centric occlusion.

16. The method of claim 12, further comprising:

a plurality of steps of vertically and forwardly adjusting the jaw various lengths for a duration of time.

17. The method of claim 12, further comprising:

a plurality of steps of variously deflecting mandibular advancement.