WO2012082090A1

WO2012082090A1 - Intra-oral device and method of relieving head, neck,facial,joint and tooth pain

Info

Publication number: WO2012082090A1
Application number: PCT/US2010/003171
Authority: WO
Inventors: Marc D. Doctors; Randy Miles Widen
Original assignee: Randmark Dental Products, LLC
Priority date: 2010-12-15
Filing date: 2010-12-15
Publication date: 2012-06-21
Also published as: CN103370027A; EP2651329A4; CA2821903A1; EP2651329A1

Abstract

A device and method for relieving head, neck, facial, joint and tooth pain. An intra-oral, semi- custom, separating device, worn over the upper anterior teeth, allows at least one lower anterior tooth to contact the rear wall of the device within the user's freeway space and prevents lower posterior teeth from contacting upper posterior teeth. The device provides a method of deprogramming and releasing the muscles of the upper and lower jaws. The device comprises an extruded or molded shell made of a hard polycarbonate or similar hard plastic resin. The internal surface of the shell is lined with a moldable thermoplastic resin with a low molding temperature which allows the user to mold the internal aspect of the device onto and over the teeth to produce a custom fit. This relieves the stresses, strains, pains and damage that can be caused by parafunctioning of the dental neural-muscular system.

Description

INTRA ORAL DEVICE AND METHOD OF RELIEVING HEAD, NECK,

FACIAL, JOINT AND TOOTH PAIN

FIELD OF THE INVENTION

[0001] The present invention relates generally to intra-oral devices and, in particular, a mass produced, semi-custom, intra-oral separator device intended to be worn by the user, for the elimination or relief of grinding, clenching, bruxing, and related parafunctional habits, as well as head, neck and jaw related pain. Grinding, clenching and bruxing and related parafunctional habits can produce structural damage to, and disease of, the teeth, gums and supporting structures including the temporomandibular joint.

BACKGROUND OF THE INVENTION

[0002] There is an enduring need for an inexpensive and effective device and method for the relief of head, neck, facial, joint and tooth pain caused by the parafunctional movement of the jaws and teeth. The design and function of the present invention are different than the prior art in form, function, cost and retail availability.

[0003] A variety of stressors affect the neuromuscular system of the head and neck.

Among them are abnormal dental contacts, muscle tension and spasms, psychological stress factors, genetic predispositions, physical trauma and inflammation. In the presence of stressors the jaw muscles contract irregularly or parafunctionally causing the hitting together of the teeth. This interarch dental contact triggers headaches, both radiating and migraine, muscular tension, inflammation, structural damage to ligaments and tendons, fractures and excessive wear of the teeth, arthritic changes to the temporomandibular joint and periodontal disease. The pain generated radiates to other muscles, namely muscles of chewing and posture within the head, neck and back. The cycle of pain and structural damage thus created becomes the motivation for the efforts to design a device and method to minimize or eliminate these symptoms.

[0004] The prior art generally employs various platforms and protuberances to separate the teeth beyond the freeway space and beyond the physiologic rest position, making them less effective in eliminating pathologic muscle engrams and less likely to disrupt the cycle of pain and structural damage. The wider the mandible is forced to open by these platforms and protuberances, the more neuromuscular feedback is created and the less likely these devices are to disrupt the existing pathologic muscle engrams. In addition, these devices often require fittings by dental professionals and are therefore inconvenient and expensive for mass usage. By contrast, the present invention, if available commercially at the retail level, would be relatively inexpensive and is customizable by the user. The present invention functions within the freeway space effectively deprogramming the neuromuscular system of the head and neck by preventing contact of the upper and lower posterior teeth.

[0005] The prior art focused on the use of medications for pain relief or the fabrication of devices whose goal was to separate the teeth and reposition the jaws. Typical of these devices are U.S. Pat. No. 4, 671,766 to Norton; U.S. Pat. No. 4,519, 386 to Sullivan; U.S. Pat. No.

5,277,203 to Hays; U.S. Pat. No. 6,581 ,603 to Schames; and U.S. Pats. Nos. 5,085,584;

5,513,656; 5,795,150; and 6,666,212 to Boyd.

[0006] These treatments are often extremely expensive or ineffective. What is needed is a device that is readily and easily obtained at a reasonable cost and is simple to customize and use.

[0007] The present invention takes into account the necessity to minimize the

impingement of a person's freeway space. The freeway space, or interocclusal space, is defined as that distance between the physiologic rest position and the first point of contact of the upper and lower teeth when the jaws are brought together. The freeway space has been observed to usually be between 2 and 7 millimeters (mm) with an approximate average for adults of 3.5 mm. The physiologic rest position is the position assumed by the mandible when the head is in an upright position, the neuromuscular system is in equilibrium in tonic contraction and the condyles are at rest. The more an intra-oral device forces the mandible to open beyond the limits of the freeway space, the more active neuromuscular feedback mechanisms become. This feedback triggers pathologic engrams. An engram is a memorized pattern of muscle activity. Pathologic engrams may also be eliminated by occlusal adjustment, occlusal reconstruction, retraining or through the use of medication. Thus the cycle of pain and structural damage can be interrupted temporarily or permanently. The prior art cause invasion beyond the limits of the freeway space, making them less likely to interrupt the cycle of pain and structural damage. What is needed, then, is a device that minimizes invasion of the freeway space and prevents contact of the upper and lower posterior teeth. By effecting disclusion of the upper and lower posterior teeth while maintaining clearance within the freeway space, the present invention will eliminate or drastically reduce pathologic engrams.

[0008] The prior art, directed to the reduction of headaches and temporomandibular joint

(TMJ) pain, function beyond the limits of a person's freeway space, allowing pathologic muscle engrams to remain, preventing the neuromuscular system from achieving the physiologic rest position. The current invention allows the user to customize the device to function within the freeway space.

[0009] Posterior disclusion with an anterior bite device is simple and well understood. It is based on the concept that the temporomandibular joint will seat itself physiologically if the proprioceptive interferences of the teeth and periodontal ligaments are removed. Thus the neuromuscular system will function freely within the freeway space. Once a patient's pathologic muscle engrams have been eliminated, the temporomandibular joint becomes stable. An occlusal adjustment with or without occlusal reconstruction may be necessary to decrease the likelihood that the cycle of pain and structural damage returns.

SUMMARY OF THE INVENTION

[0010] In one embodiment of the present invention, the external shell of the claimed device allows for the user to fit the device close to the incisal, lingual and labial surfaces of the upper anterior teeth. Contact on the device by lower anterior teeth within the freeway space promotes more predictable release of muscle engrams than contact on a device beyond the freeway space. In addition, this device does not require fittings by dental professionals and is designed for easy adaptation by a user. It is anticipated the device will be moderately priced and affordable by the great majority of those who need it.

[0011] One embodiment of the present invention relates to an intra-oral device comprising a body having a substantially angled front wall and a substantially angled rear wall, the front wall having an inner and outer surface and the rear wall having an inner and outer surface; wherein the front and the rear walls are positioned to receive the incisal edges of a user's upper anterior incisors; wherein the outer surface of the rear wall is configured to contact at least one lower incisor at an area of contact to prevent contact of the user's upper and lower posterior teeth within the user's freeway space; wherein the inner surface of the front wall is configured to be placed adjacent to the labial surface of the user's upper incisors; and wherein the inner surface of the rear wall is configured to be placed adjacent to the lingual surface of the user's upper incisors.

[0012] One embodiment of the present invention relates to a method for relieving head, neck, facial, joint and tooth pain, the method comprising placing a device within a user's oral cavity, the device having an angled front wall and an angled rear wall, each wall with an inner and outer surface, wherein the angles of the front wall and the rear wall form an apex with moldable thermoplastic resin disposed along the inner surfaces of the front and rear wall, the apex configured to receive the incisal edges of a user's upper anterior incisors; positioning the device such that the inner surface of the front wall of the device is adjacent to the labial surface of the user's upper incisors and the inner surface of the rear wall is disposed adjacent to the lingual surface of the upper incisors; and placing the device in contact with at least one lower incisor to prevent contact of a user's upper and lower posterior teeth within the freeway space.

[0013] One embodiment of the present invention relates to a method for manufacturing an intra-oral device, the method comprising forming a hard plastic resin shell having an angled front wall and an angled rear wall, each wall with an inner and outer surface, wherein the angles of the front wall and the rear wall form an apex with moldable thermoplastic resin disposed along the inner surfaces of the front and rear wall, the apex configured to receive the incisal edges of a user's upper anterior incisors; configuring the front wall of the device to fit substantially flush against the labial surface of a user's upper incisors; configuring the inner surface of the rear wall to fit substantially flush against the lingual of a user's upper incisors; and adhering to the inner surfaces of the front and rear walls a moldable thermoplastic resin.

[0014] One embodiment of the present invention relates to an intra-oral device comprising a body having a substantially angled front wall and a substantially angled rear wall, the front wall having an inner and outer surface and the rear wall having an inner and outer surface; moldable thermoplastic resin material disposed along the inner surface of the front and rear walls; wherein the front and the rear wall are positioned to receive the incisal edges of a user's upper anterior incisors; wherein the outer surface of the rear wall is configured to contact at least one lower incisor at an area of contact to prevent contact of the user's upper and lower posterior teeth within the user's freeway space; wherein the inner surface of the front wall is configured to be placed adjacent to the labial surface of the user's upper incisors; wherein the inner surface of the rear wall is configured to be placed adjacent to the lingual surface of the user's upper incisors; and wherein the moldable thermoplastic resin is capable of being molded by a user.

[0015] These and other objects and advantages of the invention will be apparent from the following description, the accompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 shows a perspective view of an embodiment of the present invention as seen from an inferior-anterior-lateral view with moldable thermoplastic resin material installed inside a hard plastic resin shell.

[0017] Figure 2 shows a central section of the embodiment of the present invention of

Fig. 1 , with a user's upper anterior teeth in place in the device and the user's lower anterior teeth in contact within the freeway space on the outside rear surface of the device.

[0018] Figure 3 shows an anterior perspective view of the embodiment of the invention of Fig. 1 in place on the user's upper anterior teeth.

[0019] Figure 4 shows a rear perspective view of the embodiment of the invention of Fig.

1 in place on the user's upper anterior teeth with the lower teeth area of contact on the outside rear surface of the device.

DETAILED DESCRIPTION OF THE INVENTION

[0020] The present disclosure will now be described more fully with reference to the

Figures in which various embodiments of the present invention are shown. The subject matter of this disclosure may, however, be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein.

[0021] Before explaining the features of this embodiment of the invention in detail, it should be understood that the invention is not limited in its application to the details of construction and arrangement of components set forth in the following description or illustrations in the drawings. The invention is capable of other embodiments and variations that will occur to those skilled in the art upon reading this disclosure. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. [0022] As illustrated in Figures 1-4, a semi-custom intra-oral separator device, constructed in accordance with one embodiment of the present invention, is comprised of a hard plastic resin main body 10 with moldable thermoplastic resin disposed upon the inner surfaces of the main body 10 which is configured to be positioned on a user's teeth. In particular, the main body 10 is comprised of an angled front wall 11 and an angled rear wall 12. Front wall 11 approximates the angle and configuration of the labial surfaces of maxillary anterior incisors 19 and anterior maxillary dental arch and the rear wall 12 approximates the angle and configuration of the lingual surfaces of maxillary anterior incisors 19 and anterior maxillary dental arch. In one or more embodiments, the front wall 11 is configured to fit substantially flush against the labial surface of a user's upper incisors 19. In one or more embodiments, the rear wall 12 is configured to fit substantially flush against the lingual surface of a user's upper incisors 19. Contact is made on the device 18 by a lower anterior tooth 20 within the freeway space 21. While the main body is described above as being constructed of hard plastic resin, one skilled in the art recognizes that it may be constructed of any suitable material known or used in the art.

[0023] The angle of front wall 11, and the angle of rear wall 12 forms an apex 15, approximating the angle of the labial and lingual surfaces of maxillary incisors. Apex 15 is configured to receive the incisal edges of a user's upper anterior incisors. As is apparent in Figure 2 and Figure 4, when the device is in place, the incisal edges of the lower anterior teeth contact outer surface 16, preventing the lower posterior teeth from coming into contact with the upper posterior teeth. The lower anterior teeth are in contact with the device as the mandible reaches the end of its hinge arc of closure in one embodiment. The thickness between outer surface 16 and inner surface 17 is approximately 1.25 mm. The thickness of the moldable thermoplastic resin 13 is approximately 0.5 mm. While an embodiment of the present invention is described above with specificity, one skilled in the art recognizes that the thickness between the outer surface and inner surface, as well as the thickness of the moldable thermoplastic resin may vary. The moldable thermoplastic resin 13 may be comprised of moldable thermoplastic acetate co-polymer resin, such as Dupont Elvax® EVA resin or other material with similar properties, fixed in place on the inner surfaces of front 11 and rear 12 walls, by detents 14, as shown in Figure 2. The moldable thermoplastic resin may also be retained and/or adhered on the inner surfaces of walls 1 1 and 12 by use of adhesive, mechanical restraints, or any other similar attachment means known in the art. [0024] In the above-described embodiment, to customize the device, the device is placed in water at approximately 140-180° F to soften the moldable thermoplastic resin. The device is then fitted and molded by the user. To fit and mold the device, the user pushes the softened moldable thermoplastic resin onto the anterior incisors until the teeth "seat" into the apex of the interior angle between the front 11 and rear 12 walls of the device. The user then closes the mandibular incisors against the outer surface 16, of the device to adapt the device against the lingual surfaces of the upper incisors 19 within the device.

[0025] Figure 2 and Figure 4 show an embodiment of the present invention in place after molding and lower teeth 20 in contact at area of contact 18, with outer surface 16 of the device, a position from which the user can move the mandibular anterior incisors laterally, protrusively and retrusively along the area of contact 18, on outer surface 16.

[0026] Figure 3 shows a front view of the extent of coverage of an embodiment of the present invention in place on the upper anterior teeth.

[0027] Figure 4 shows an area of contact 18 of the mandibular incisors 20 which allows the mandibular incisors to proprioceptively sense contact with the outer surface 16 of an embodiment of the present invention, and to initiate release of parafunctional pathologic muscle engrams more particularly, the reprogramming of muscle engrams can lead to the reduction of symptoms of stress from occlusal or psychological initiators. In one or more embodiments, the invention device may proprioceptively guide the user's mandible within the freeway space 21.

[0028] The foregoing descriptions of specific embodiments of the present invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations are possible in view of the above teachings. While the embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, thereby enabling others skilled in the art to best utilize the invention, various embodiments with various modifications as are suited to the particular use are also possible. The scope of the invention is to be defined only by the claims appended hereto, and by their equivalents.

Claims

CLAIMS What is claimed is:

1. An intra-oral device comprising:

a body having a substantially angled front wall and a substantially angled rear wall, the front wall having an inner and outer surface and the rear wall having an inner and outer surface;

wherein the front wall and the rear wall are positioned to receive the incisal edges of a user's upper anterior incisors;

wherein the outer surface of the rear wall is configured to contact at least one lower incisor at an area of contact to prevent contact of the user's upper and lower posterior teeth within the user's freeway space;

wherein the inner surface of the front wall is configured to be placed adjacent to the labial surface of the user's upper incisors; and

wherein the inner surface of the rear wall is configured to be placed adjacent to the lingual surface of the user's upper incisors.

2. The device of claim 1 , wherein the rear wall of the device is configured to contact the user's lower anterior incisors within the freeway space.

3. The device of claim 1, wherein the device is configured to allow a user's lower incisors to move along the mandibular arc of closure.

4. The device of claim 1, wherein the device is configured to allow a user's lower incisors to move laterally, retrusively and protrusively.

5. The device of claim 1, further comprising an amount of moldable thermoplastic resin

material disposed along the inner surfaces of the front and rear walls.

6. The device of claim 5, further comprising means to retain the moldable thermoplastic resin material within the inner surfaces of the front and rear walls.

7. The device of claim 5, wherein the means for retaining the moldable thermoplastic resin material comprise detents on the inner surfaces of the front and rear walls.

8. The device of claim 5, wherein the means for retaining the moldable thermoplastic resin material comprise adhesion on the inner surfaces of the front and rear walls.

9. The device of claim 5, wherein the moldable thermoplastic resin material is capable of being molded at approximately 140-180°F.

10. A method for relieving head, neck, facial, joint and tooth pain, the method comprising: placing a device within a user's oral cavity, the device having an angled front wall and an angled rear wall, each wall with an inner and outer surface, wherein the angles of the front wall and the rear wall form an apex with moldable thermo plastic resin material disposed along the inner surfaces of the front and rear wall, the apex configured to receive the incisal edges of a user's upper anterior incisors;

positioning the device such that the front wall of the device is adjacent to the labial surface of the user's upper incisors and the inner surface of the rear wall is disposed adjacent to the lingual surface of the upper incisors; and

placing the device in contact with at least one lower incisor at an area of contact to prevent contact of a user's upper and lower posterior teeth within the freeway space.

1 1. The method of claim 10, further comprising the step of molding the moldable thermoplastic resin material.

12. The method of claim 10, further comprising the step of heating the moldable thermoplastic resin material to approximately 140- 180 °F.

13. The method of claim 10, wherein the device's rear wall is approximately 1.25 millimeters thick.

14. The method of claim 10, wherein the device is configured to prevent contact between the user's upper and lower posterior teeth.

15. The method of claim 10, wherein the device proprioceptively guides the user's mandible within the freeway space.

16. A method for manufacturing an intra-oral device, the method comprising:

forming a hard plastic resin material shell having an angled front wall and an angled rear wall, each wall with an inner and outer surface, wherein the angles of the front wall and the rear wall form an apex with moldable thermoplastic resin material disposed along the inner surfaces of the front and rear wall, the apex configured to receive the incisal edges of a user's upper anterior incisors;

configuring the inner surface of the front wall of the device to fit substantially flush against the labial surface of a user's upper incisors; configuring the inner surface of the rear wall to fit substantially flush against the lingual surface of a user's upper incisors; configuring the rear wall of the device to contact at least one lower incisor within the user's freeway space; and

adhering a moldable thermoplastic resin material to the inner surfaces of the front and rear walls.

17. The method of claim 16, wherein the shell is formed from hard plastic resin material.

18. The method of claim 16, wherein the moldable thermoplastic resin material is capable of being moldable at approximately 140-180°F.

19. An intra-oral device comprising:

moldable thermoplastic resin material disposed along the inner surface of the front and rear walls;

wherein the front and the rear wall are configured to receive the incisal edges of a user's upper anterior incisors;

wherein the outer surface of the rear wall is configured to contact at least one lower incisor at an area of contact to prevent contact of the user's upper and lower posterior teeth within the freeway space;

wherein the inner surface of the front wall is configured to be placed adjacent to the labial surface of the user's upper incisors;

wherein the inner surface of the rear wall is configured to be placed adjacent to the lingual surface of the user's upper incisors; and

wherein the moldable thermoplastic resin material is capable of being molded.

20. A method for relieving head, neck, facial, joint and tooth pain, the method comprising

placing a device within a user's oral cavity;

positioning the device such that a wall of the device is disposed adjacent to the lingual surface of the upper incisors; and

placing the device in contact with at least one lower incisor to prevent contact of a user's upper and lower posterior teeth.

21. The method of claim 20, wherein the device is configured to contact at least one lower incisor within the user's freeway space.