Abstract:
A prosthesis for insertion in an ear to reduce pain resulting from TMJ disorders. The ear insert has a predefined shape conforming to the shape of the ear canal when the jaw is in an open position. The ear insert supports the TMJ and associated secondary musculature to reduce strain in the TMJ area, including the muscles, ligaments, nerves, and the temporo-mandibular joint itself. The insert is hollow in the inside to permit hearing and is made of a rigid material which retains the shape of the ear canal. A scalloped indenture extends across a surface of the ear insert positioned behind the tragus.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application is a divisional of copending U.S. patent application Ser. No. 12/075,046, filed Mar. 7, 2008, which is pending and is incorporated by reference in its entirety herein. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to medical devices, and more particularly, to medical devices for alleviation of jaw discomfort. 
     BACKGROUND 
     Many people suffer from pain in the joint located between the skull and the jaw. The joint is formed between the temporal bone of the skull and the mandible or jaw bone, and is commonly known as the temporo-mandibular joint or “TMJ”. The human body has two temporo-mandibular joints, one located on each side of the jaw in front of each ear. The TMJs move every time a person chews, talks, or swallows. 
     In greater detail, the TMJ is a paired joint articulating the mandibular condyle, articulator disc, and squamous portion of the temporal bone. The TMJ is capable of both glide and hinge movements. Specifically, the TMJ is formed by the mandibular condyle fitting into the mandibular fossa of the temporal bone. A separation of these two bones is accomplished by the articulator disc which is composed of dense fibrous connective tissue. Ligaments attach the articulator disc to the condyle, permitting rotational movement of the articulator disc during mouth opening and closure. 
     Displacement of the articulator disc introduces strain to the jaw muscles and causes muscle pain or fatigue around the jaw. In addition, articulator disc displacement often causes a painful clicking in the TMJ during certain jaw movements as the disc moves between normal and displaced positions. A number of other symptoms may occur as a result of a strained disc, including TMJ lock, shoulder, neck, and back pain, and headaches. 
     Unfortunately, conventional methods of treating temporo-mandibular joint disorders can be costly, physically cumbersome, involve invasive and irreversible treatment or be time consuming. Some conservative methods for treating TMJ discomfort include the use of an intra-oral splint, medication, and life style changes. One type of intra-oral splint is a stabilization apparatus which is used to help alter the posture of the mandible to a more open, relaxed, resting position. Another type of intra-oral splint is an anterior positioning apparatus. The anterior positioning apparatus attempts to decrease the compression load on the joint and alter the structural condyle disc relation. Both types of splints, however, cannot be used full time without risking displacement of teeth. Treatment by medication often involves the use of addictive drugs and/or anti-depressants and therefore can lead to misuse and abuse. In addition, medications often produce adverse side effects in the patient. Other conservative methods include chiropractic or physical therapy. Unfortunately, these methods require extensive time commitments and physical exertion by the patient. 
     More aggressive treatment of TMJ discomfort includes orthodontic treatment such as grinding down of teeth and various types of surgery. Orthodontic treatments, however, merely indirectly address TMJ pain by adjusting the dental articulation and overall bite of the patient. Furthermore, orthodontic approaches are invasive, irreversible, and expensive. 
     An alternative procedure and related apparatus for treatment of TMJ discomfort are disclosed in U.S. Pat. No. 5,769,891, the contents of which are incorporated by reference herein in their entirety. According to the disclosure in U.S. Pat. No. 5,769,891, a prosthesis is provided for insertion into the ear canal. The prosthesis has a rigid structural portion of a shape conforming to the ear canal when the jaw is in an open position. The prosthesis provides added support to the TMJ and associated secondary musculature to reduce strain in the TMJ area. 
     SUMMARY OF THE DISCLOSURE 
     According to one aspect, the present disclosure provides an ear canal insert for treating TMJ disorders which acts directly on the TMJ and associated ligament and muscle structures to reduce stress and loads placed on the articulator disc located between the temporal bone and the mandible, as well as supportive muscles and ligaments near the TMJ. The insert includes a base portion adapted to reside adjacent the opening of the ear canal with a portion of the base support extending into the inter-tragal notch to reside at a position between the tragus and anti-tragus portions of the outer ear following insertion. The base portion further includes a scalloped indenture extending away from a boundary edge of the base portion across an outwardly facing lateral surface of the insert. 
     According to another aspect, the present disclosure provides an ear canal insert for treating TMJ disorders which acts directly on the TMJ and associated ligament and muscle structures to reduce stress and loads placed on the articulator disc located between the temporal bone and the mandible, as well as supportive muscles and ligaments near the TMJ. The insert includes a base portion adapted to reside adjacent the opening of the ear canal following insertion. At least one anterior projecting post element projects outwardly away from a boundary edge of the base portion to a position outside of the ear canal to facilitate insertion and removal of the insert. 
     These and other aspects of the disclosure will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an isometric view of an exemplary prosthesis for insertion into an ear canal for treatment of TMJ discomfort; 
         FIG. 2  is a view illustrating an outer ear; 
         FIG. 3  is cut-away side view of the prosthesis of  FIG. 1  inserted into an ear canal; 
         FIG. 4  is a side view of a TMJ in an unoccluded position showing a disc in the normal position; and 
         FIG. 5  is a side view of a TMJ in the closed position showing a disc in the displaced position. 
     
    
    
     While the concepts of the instant disclosure are susceptible to various modifications and alternative constructions, certain illustrative embodiments thereof have been shown in the drawings and will be described below in detail. It should be understood, however, that there is no intention to limit the invention to the specific forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions and equivalents falling within the spirit and scope of the disclosure as defined by the appended claims and all equivalents thereto. 
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     Exemplary constructions and practices will now be described through reference to the drawings, wherein like elements are designated by like reference numerals in the various views. For purposes of illustration,  FIG. 1  illustrates a prosthesis  10  adapted for insertion into an ear canal  12  as shown generally in  FIG. 3 . According to a contemplated practice, the prosthesis  10  includes a hollow structural body portion  14  molded from a substantially rigid material such as acrylic or the like. Accordingly, the structural body portion  14  is substantially incompressible and maintains its shape upon insertion. 
     In the illustrated construction, the structural body portion  14  is substantially hollow along its length to facilitate sound transmission. The structural body portion  14  has a three-dimensional exterior shape corresponding substantially to the shape of ear canal  12  when a user&#39;s mouth is in an open position. Thus, following insertion of the prosthesis  10 , the structural body portion  14  is in substantially conforming relation relative to contours at the inner surface of the ear canal  12  such that the prosthesis  10  is held in a substantially nested relation relative to the interior surface of the ear canal  12 . If desired, one or more additional compressible cushioning layers (not shown) may be provided around at least apportion of the rigid structural body portion  14 . However, such a cushioning layer is in no way essential. By way of example only, and not limitation, materials for forming such a cushioning layer may include PVC, silicone or the like. 
     As shown in the illustrated construction, the structural body portion  14  includes a proximal base portion  16  and a distal end portion  18 . The proximal base portion  16  is of greater diameter than the distal end portion  18 . As best illustrated in  FIG. 3 , the proximal base portion  16  is adapted to be positioned in inserted relation substantially adjacent the opening of ear canal  12 . In the illustrated construction, the proximal base portion  16  includes an extended peninsular leg portion  19  adapted to project generally downwardly when the structural body portion  14  is in inserted position within the ear canal  12 . In this regard, the peninsular leg portion  19  projects into the inter-tragal notch  21  shown in  FIG. 2  adjacent to the tragus  36  and the opposing anti-tragus  38  portions of the outer ear. The distal end portion  18  of the structural body portion  14  is adapted to extend approximately to the bend in the ear canal known as the isthmus  22 . The isthmus  22  is in close proximity to the temporo-mandibular joint and is located approximately 20-22 millimeters from the outside of an adult ear. However, this distance may vary in different individuals. 
     As best illustrated through joint reference to  FIGS. 1 and 3 , according to the illustrated construction, a scalloped indenture  30  extends away from an edge of the proximal base portion  16 . In this regard, it is contemplated that the scalloped indenture  30  may be formed by any suitable technique as may be desired. By way of example only, and not limitation, one such technique involves post-formation sculpting using cutting tools or the like although other techniques may be used as desired. As shown, the scalloped indenture  30  extends generally towards the distal end portion  18  and is positioned across a surface of the structural body portion  14  adapted reside immediately behind the tragus  36  and opposing anti-tragus  38  of the outer ear. It is contemplated that the scalloped indenture  30  may have a length and width suitable to accept substantially the entire lobe of the tragus  36  thereby facilitating the ability of the tragus  36  to bend inwardly towards the opening of ear canal  12  substantially without obstruction. Surprisingly, it has been found that the structural body portion  14  incorporating such a scalloped indenture  30  maintains its structural integrity to provide jaw support as described further hereinafter despite the substantial reduction in supporting material. 
     According to the illustrated construction, it is contemplated that at least one anterior projecting post element  40  may extend away from a surface of the peninsular leg portion  19 . As shown, the post element  40  projects in a direction extending generally away from the distal end portion  18  so as to project towards the exterior of the ear. Following insertion, at least a portion of the post element  40  may reside outside of the ear canal  12  at a position within the vicinity of the inter-tragal notch  21 . In this position, a wearer may grasp the post element  40  to facilitate removal of the insert. 
     The post element  40  is preferably substantially pliable to enhance insertabilty and removability and to avoid discomfort to the wearer. At the same time, the post element  40  should be characterized by sufficient strength to avoid breakage. By way of example only, and not limitation, it has been found that a suitable post element  40  may be formed from thermoplastic monofilament nylon adhesively bonded onto a surface of the peninsular leg portion  19 . However, other suitable polymeric or non-polymeric materials may likewise be utilized if desired. 
     As shown, the post element  40  may include a bulbous head portion  41 . Such a bulbous head portion  41  may enhance the ability of a wearer to grasp the post element  40  during removal of the prosthesis  10  from the ear canal  12 . In the event that the post element  40  is formed from nylon or other thermoplastic material, a suitable bulbous head portion  41  may be formed by selectively melting the terminal end of the post element  40  to form a melted polymer bead which is thereafter permitted to resolidify. The surface of the resolidified bead may thereafter be smoothed by sanding or other suitable treatment to remove irregularities so as to enhance comfort during use. 
     Referring now to  FIGS. 4 and 5 , the use of the prosthesis  10  influences the relationship between the temporal bone  44  and the mandible  46  in each temporo-mandibular joint  48 , thereby relieving pain inducing stress in the temporo-mandibular joint  48  and related muscles, ligaments, and nerves. In this regard, it will be appreciated that one source of temporo-mandibular joint discomfort is a dislocated articulator disc  50 . As shown in  FIG. 4 , when the jaw or mandible  46  is in an open or unoccluded position corresponding to the mouth being open, the articulator disc  50  is usually in a normal, unstrained position between the temporal bone  44  and a condyle surface of the mandible  46 . As is often the case with a person experiencing temporo-mandibular joint discomfort, the articulator disc  50  slips to a displaced position when the mandible  46  is subsequently closed, as illustrated in  FIG. 5 . The displacement of the articulator disc  50  is often indicated by a clicking or popping noise as the mandible  46  moves between open and closed positions. In the displaced position, the articulator disc  50  is no longer between the condyle surface and the temporal bone  44 , and the articulator disc  50  and attached ligaments become strained. Strain on these members stresses the surrounding muscles, which may ultimately result in face, neck, and back pain. 
     To treat temporo-mandibular joint discomfort arising from a displaced articulator disc  50 , the prosthesis  10  is provided for reducing stresses and loads on the articulator disc  50 . The prosthesis  10  reshapes the ear canal and provides a rigid structure which helps align the temporo-mandibular joint  48  and associated muscle and ligament structures so that the temporo-mandibular joint  48  has a normal rotational movement. Strain or compression on the articulator disc  50  is therefore reduced, thereby alleviating pain in the temporo-mandibular joint and associated structures. 
     It is to be understood a dislocated disc is only one cause of temporo-mandibular joint discomfort and that there are many other sources of such pain. Nerves, ligaments, and muscle groups (such as the masticatory musculature) are located proximal to the temporo-mandibular joint, and improper loading, strain, or alignment of these members provide potential sources of temporo-mandibular joint pain. Rather than being limited to disc dislocation situations, as outlined above, the prosthesis  10  addresses misalignment and stress in the temporo-mandibular joint and related structures by supporting these structures for normal rotational movement. 
     It will be appreciated that the prosthesis  10  alleviates temporo-mandibular joint discomfort by supporting the temporo-mandibular joint  48  and associated muscles, nerves, and ligaments for proper rotation of the mandible between open and closed positions. The prosthesis  10  is formed to correspond to the shape of the ear canal  12  when the mandible  46  is open and disc  50  is in the normal position. When the mandible  46  is subsequently closed, the prosthesis  10  maintains the positioning of the mandible  46  the so that the disc  50  is not displaced. Accordingly, a natural body orifice is used to reposition the mandible  46  without requiring surgery or other painful and invasive techniques. As noted above, the example of a dislocated disc is merely illustrative of a temporo-mandibular joint condition addressed by the present device and is in no means meant to limit the scope of the present invention. Accordingly, it will be appreciated that the present device addresses stresses and misalignments in not only the disc but also any muscles, ligaments, and nerves associated with the temporo-mandibular joint. 
     It will be appreciated that the foregoing description provides examples of the disclosed apparatus and method of use. However, it is contemplated that other implementations of the disclosure may differ in detail from the foregoing examples. All references to examples herein are intended to reference the particular example being discussed at that point and are not intended to imply any limitation as to the scope of the disclosure or claims more generally. All language of distinction and disparagement with respect to certain features is intended to indicate a lack of preference for those features, but not to exclude such from the scope of the claims entirely unless otherwise indicated. 
     Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. 
     Accordingly, this disclosure contemplates the inclusion of all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is contemplated unless otherwise indicated herein or otherwise clearly contradicted by context.