Abstract:
A device and method for relieving head, neck, facial, joint and tooth pain. An intra-oral device, worn over the upper or lower incisors, allows at least one opposite tooth to contact the rear wall of the device, only within the user&#39;s freeway space, and prevents upper and lower posterior teeth from contacting. The device facilitates deprogramming and releasing of the upper and lower jaw muscles. The device includes an extruded or molded shell made of a hard polycarbonate or similar hard plastic material. The internal surface of the shell may be secured in place for the user or lined with a low molding temperature thermoplastic resin, allowing the user to mold the internal aspect of the device onto and over the teeth to produce a fitted device. This relieves the stresses, strains, pains and damage that can be caused by parafunctioning of the dental neural-muscular system.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 12/379,194, filed Feb. 13, 2009, which claims the benefit of U.S. Provisional Application No. 61/064,048, filed Feb. 13, 2008, the disclosures of which are hereby incorporated in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to intra-oral devices and, in particular, a mass produced, 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 
       [0003]    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. 
         [0004]    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 for 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 to minimize or eliminate these symptoms. 
         [0005]    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, one embodiment of the device of the present invention is installed by the user, and would be relatively inexpensive at the retail level. The device of the present invention functions within the freeway space to effectively deprogram the neuromuscular system of the head and neck by preventing contact of the upper and lower posterior teeth. 
         [0006]    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. 
         [0007]    These treatments are often extremely expensive and/or ineffective. A more effective device and treatment are needed, as well as a device that is readily and easily obtained at a reasonable cost and is simple to install and use. 
         [0008]    The present invention takes into account the need to eliminate the forced positioning of a person&#39;s mandible to or beyond the physiologic rest position. The freeway space, or interocclusal space, is defined as the 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 minimum tonic contraction and the condyles are at rest. The more an intra-oral device forces the mandible to open beyond the physiologic rest position, 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 remediated or 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. Prior art devices and methods cause the mandible to be forced open beyond the limit of the freeway space, making them less likely to interrupt the cycle of pain and structural damage. What is needed, then, are a device and method that functions only within the freeway space, while effecting disclusion of the posterior teeth and maintaining clearance within the freeway space, thereby eliminating or significantly reducing pathologic engrams. 
         [0009]    The prior art, directed to the reduction of headaches and temporomandibular joint (TMJ) pain, functions outside of a user&#39;s freeway space. In one of its aspects, the present invention provides a device that may be installed by a dental professional to fit a user. In another aspect, the present invention allows a user to fit the device to function only within the freeway space. 
         [0010]    Posterior disclusion with an anterior bite device 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 user&#39;s pathologic muscle engrams have been eliminated, the temporomandibular joint becomes stable. In order to decrease the likelihood of the cycle of pain and structural damage returning, an occlusal adjustment with or without occlusal reconstruction may be necessary. 
       SUMMARY OF THE INVENTION 
       [0011]    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 or lower anterior teeth, also referred to as upper or lower incisors. Contact on the device by the opposite incisors, only within the freeway space, promotes more predictable release of muscle engrams than contact on a device outside the freeway space. In addition, devices according to the invention may either be fitted by dental professionals or 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. 
         [0012]    Another 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 rear walls are positioned to receive the incisal edges of a user&#39;s upper or lower incisors; wherein the outer surface of the wall that faces the incisors of the opposite arch is configured within the user&#39;s freeway space to contact at least one opposite incisor at an area of contact only within the user&#39;s freeway space to prevent contact between the user&#39;s upper and lower teeth; wherein the inner surface of the front wall is configured to be placed adjacent to the labial surface, and the inner surface of the rear wall adjacent to the lingual surface, of the user&#39;s upper or lower incisors. 
         [0013]    Still another 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&#39;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, optionally with moldable thermoplastic resin disposed along the inner surfaces of the front and rear wall. The apex is configured to receive the incisal edges of a user&#39;s upper or lower incisors. The device is positioned such that the inner surface of the front wall of the device is adjacent to the labial surface, and the inner surface of the rear wall adjacent to the lingual surface, of the user&#39;s upper or lower incisors; and the device is configured to contact at least one opposite incisor to prevent contact between a user&#39;s upper and lower teeth. 
         [0014]    Yet another 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, optionally 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&#39;s upper or lower incisors. The inner surface of the front wall of the device is configured to fit substantially flush against the labial surface, and the inner surface of the rear wall to fit substantially flush against the lingual surface, of a user&#39;s upper or lower incisors. Alternatively, the method includes molding the hard plastic shell to form a device of unitary construction secured to a user&#39;s teeth. 
         [0015]    Still another 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 capable of being molded by a user is optionally disposed along the inner surfaces of the front and rear walls, and the front and rear walls are positioned to receive the incisal edges of a user&#39;s upper or lower incisors; wherein the outer surface of the wall that faces the incisors of the opposite arch is configured to contact at least one opposite incisor at an area of contact only within the user&#39;s freeway space to prevent contact between the user&#39;s upper and lower teeth; wherein the inner surface of the front wall is configured to be placed adjacent to the labial surface, and the inner surface of the rear wall to be placed adjacent to the lingual surface, of the user&#39;s upper or lower incisors. 
         [0016]    In other embodiments of the invention, intra-oral devices are provided that do not necessarily have front and rear walls meeting to form an apex, resulting in a “V”-shaped profile to straddle the labial and lingual surfaces of the teeth to which they are mounted. Rather, a device according to the invention may be removably secured in place to a user&#39;s upper or lower incisors by any suitable means, including but not limited to thermoplastic forming, spring loading, cementation, thermoplastic resin molding, pressure fit, bonding, adhering, or friction fit. 
         [0017]    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 
         [0018]      FIG. 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. 
           [0019]      FIG. 2  shows a central section of the embodiment of the present invention of  FIG. 1 , with a user&#39;s upper incisors in place in the device and the user&#39;s lower incisors in contact within the user&#39;s freeway space on the outer surface of the rear wall of the device. 
           [0020]      FIG. 2   a  shows a central section of the embodiment of the present invention of  FIG. 1  with upper incisors in place in the device and the lower teeth in the physiologic rest position and not in contact with the device. 
           [0021]      FIG. 3  shows an anterior perspective view of the embodiment of the invention of  FIG. 1  in place on the user&#39;s upper incisors. 
           [0022]      FIG. 4  shows a rear perspective view of the embodiment of the invention of  FIG. 1  in place on the user&#39;s upper incisors indicating the area of contact, within the user&#39;s freeway space, of the user&#39;s lower teeth on the outer surface of the rear wall of the device. 
           [0023]      FIG. 5  shows a central section of an alternative embodiment of the present invention with lower incisors in place in the device and the mandible in the physiologic rest position, the upper teeth being not in contact with the device. 
           [0024]      FIG. 6  shows a central section of an alternative embodiment of the present invention in which a device is mounted on a user&#39;s upper incisors by being secured in contact with the lingual surface of the user&#39;s upper incisors. 
           [0025]      FIG. 7  shows a central section of an alternative embodiment of the present invention in which a device is mounted on a user&#39;s lower dental arch by being secured in contact with the labial surface and incisal edge of the user&#39;s lower incisors. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    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. 
         [0027]    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. 
         [0028]    As illustrated in  FIGS. 1-4 , an interocclusal separator device  10 , constructed in accordance with one embodiment of the present invention, is comprised of a hard plastic resin main body at  10  with a layer of moldable thermoplastic resin  13  disposed upon the inner surfaces of the main body at  10  which is configured to be positioned on a user&#39;s teeth. In particular, the main body at  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 (also termed “upper” herein) incisors U and anterior maxillary dental arch and the rear wall  12  approximates the angle and configuration of the lingual surfaces of maxillary anterior incisors U 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&#39;s upper incisors U. In one or more embodiments, rear wall  12  is configured to fit substantially flush against the lingual surface of a user&#39;s upper incisors U and to contact the user&#39;s lower incisors L only within the user&#39;s freeway space F, as illustrated for example in  FIG. 2 , with freeway space F being indicated by the double arrow extending from upper incisor U through area of contact  18  to the position of a lower incisor at the physiologic rest position PRP, depicted in phantom lines. As further illustrated in  FIG. 2   a , where lower incisor L is depicted in the physiologic rest position PRP, lower incisor L does not contact outer surface  16  or any other part of the device when the mandible is at physiologic rest, and thus, nor do any of the lower teeth. A clearance C is shown in  FIG. 2   a  between lower incisor L and outer surface  16 . 
         [0029]    Front wall  11  and rear wall  12  meet to form an apex  15  approximating the angle of the labial and lingual surfaces of upper incisors U. Apex  15  is configured to receive the incisal edges of upper incisors U. As is apparent in  FIG. 2  and  FIG. 4 , when the device is in place, the incisal edges of lower incisors L contact outer surface  16  within freeway space F when the user&#39;s jaw closes, preventing the lower posterior teeth from coming into contact with the upper posterior teeth. Lower incisors L are in contact with the device as the mandible nears the end of its hinge arc of closure in one embodiment. The thickness between outer surface  16  and inner surface  17  is approximately 1.00 mm. The thickness of moldable thermoplastic resin  13  is initially approximately 0.5 mm, before the device is fit, but resin  13  is reduced to a negligible thickness by spreading and forming when resin  13  is at a molding temperature and a user pushes the device  10  against the user&#39;s upper incisors U to fit the device. Thus, the total approximate distance after the device is fit between a user&#39;s upper and lower incisors L when the user&#39;s lower incisors L contact the device is approximately 1.00 mm, where the inner surface of the outer shell  16  becomes substantially flush against the lingual surface of the user&#39;s upper incisors U so that the device is disposed within the freeway space F. 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, although keeping these layers purposely thin is imperative to ensure that the device functions within the freeway space, leaving a clearance C within freeway space F, so that the lower teeth of the user do not contact the device and cause the mandible to open beyond the physiologic rest position when the device is worn in accordance with the invention. 
         [0030]    The moldable thermoplastic resin  13  may be comprised of moldable thermoplastic acetate co-polymer resin, such as a DuPont Elvax® or other ethylene vinyl acetate copolymer resin, a polycaprolactone resin, another material with similar properties, or a mixture of materials with similar properties, fixed in place on the inner surfaces of front wall  11  and rear wall  12 . Thermoplastic flow properties of the selected material or mixture of materials on tooth surfaces at a suitable molding temperature influence how well the device may be fitted to the incisors, which in turn influences how well the device will be retained in a user&#39;s mouth. Melt flow index (“MFI”) is a measurement of the mass flow rate of extrusion of a resin through an orifice of defined dimensions at a specified extrusion temperature and load. In experiments performed on polycaprolactone resins of different molecular weights, using a 2.16 kg load, a 1-inch diameter round PVC die, and a resin extrusion temperature of either 80° C. or 160° C. as indicated, the resulting MFI&#39;s in decigrams/minute (dg/min) were as indicated in the below Table: 
         [0000]    
       
         
               
               
               
               
             
           
               
                 TABLE 
               
               
                   
               
               
                   
                 Molecular  
                 MFI (dg/min)/ 
                 Melting  
               
               
                   
                 Wt. (g/mol) 
                 Extrusion Temp (° C.) 
                 point (° C.) 
               
               
                   
               
             
             
               
                 Polycaprolactone 
                 25,000 
                  9/80 
                 58-60 
               
               
                 Polycaprolactone 
                 37,000 
                  40/160 
                 58-60 
               
               
                 Polycaprolactone 
                 43,000 
                  13/160 
                 58-60 
               
               
                 Polycaprolactone 
                 50,000 
                  7/160 
                 58-60 
               
               
                   
               
             
          
         
       
     
         [0031]    Thermoplastic resin  13  may be fixed in place on front wall  11  and rear wall  12  by detents  14 , as shown in  FIG. 2 . The moldable thermoplastic resin may also be retained and/or adhered on the inner surfaces of walls  11  and  12  by use of adhesive, mechanical restraints, or any other similar attachment means known in the art. 
         [0032]    In the above-described embodiment, to fit the device, the device is placed in water at a sufficiently high temperature to soften the moldable thermoplastic resin and so that the resin remains softened for a sufficient time for a user to fit and mold the device in the user&#39;s mouth. If thermoplastic resin  13  is one of the polycaprolactone materials tabulated above, it is desirable to heat the device in water at a suitable temperature to heat resin  13  to a temperature above its melting temperature of about 58-60° C. (136-140° F.), but not significantly above 82° C. (180° F.), as a user&#39;s mouth typically will not comfortably tolerate temperatures above around 180° F. Among the polycaprolactone materials, it was found that the 37,000 g/mol polycaprolactone seems to flow the best around a user&#39;s teeth, though the other materials may be suitable as well. Other suitable materials may have lower melting/softening temperatures, but they should not be significantly lower than around 120° F., to avoid the material softening and deforming from its fitted and molded shape during normal use and/or in the event that the device is stored in a hot place, such as a hot vehicle, for example. Once heated, 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 upper incisors U until the teeth “seat” to the apex of the interior angle between front and rear walls  11  and  12  of the device. The user then closes mandibular (also termed “lower” herein) incisors L against outer surface  16  of device  10  to adapt device  10  substantially flush against the lingual surfaces of upper incisors U within device  10 . 
         [0033]      FIG. 3  shows a front view of the extent of coverage of an embodiment of the present invention in place on the upper anterior teeth. 
         [0034]      FIG. 4  shows an area of contact  18  of the mandibular incisors L which allows mandibular incisors L to proprioceptively sense contact within the freeway space with 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 parafunction from occlusal stress or psychological initiators. In one or more embodiments, by effecting the release of pathologic muscle engrams because the device functions only within the freeway space, the device of the invention may proprioceptively, as opposed to forcibly, direct the user&#39;s mandible to the physiologic rest position. 
         [0035]    The claimed device functions in the gap between the physiologic rest position and the first contact with the device by the user&#39;s lower anterior teeth, which is illustrated in  FIG. 2 . The gap within the freeway space where no contact occurs between the claimed device and the lower anterior teeth creates a zone of proprioceptive awareness and permits the reflex that guides the user&#39;s mandible back to the physiologic rest position, thus effecting muscle relaxation. The claimed device creates a point of reference along the arc of closure, within the freeway space, at which the mandibular teeth proprioceptively sense the first point of contact with the device. Contact of lower incisors L with the device at that point of reference, when the user&#39;s mandible is already closed past the physiologic rest position, causes a natural relaxation response in which the jaw muscles reflexively relax and the mandible reflexively opens to the physiologic rest position, upon sensing the contact. 
         [0036]      FIG. 5  is an illustration of an alternative embodiment of a lower-mounted device  20  according to the invention that is adapted to fit on a user&#39;s lower incisors L in substantially the same manner as described above for upper-mounted device  10 . In particular, device  20  includes a hard plastic resin main body  22 , comprised of a front wall  24  and a rear wall  26  meeting to form an apex  28  configured to receive the incisal edges of a user&#39;s lower incisors L. An inner surface of front wall  24  is designed to fit substantially flush against the labial surface, and an inner surface of rear wall  26  to fit substantially flush against the lingual surface, of lower incisors L when the device is worn by the user in accordance with the invention. 
         [0037]    Device  20  also functions in a manner substantially similar to that of device  10 . Device  20  fits wholly within the limits of the user&#39;s freeway space, i.e., device  20  is configured so that when a user&#39;s upper incisors U contact device  20 , contact occurs only at an area of contact  30  that is wholly within the user&#39;s freeway space. Device  20  does not contact upper incisors U, or any of the user&#39;s other upper teeth, when the user&#39;s lower jaw is in the physiologic rest position indicated as PRP in  FIG. 5 . Rather, device  20  is configured to maintain a clearance C from upper incisors U, within freeway space F, when the user&#39;s jaw is at rest. As in device  10 , a layer of moldable thermoplastic resin  32  may optionally be disposed over the inner surfaces of main body  22  in an embodiment, retained by detents  34  or by other suitable means. 
         [0038]    Although devices  10  and  20  are described and illustrated with reference to  FIGS. 1-5  as being formed from hard plastic resin with moldable thermoplastic resin affixed thereto alternative upper and lower mounted intra-oral devices may be formed in any suitable manner so that an area of contact of the devices is configured to be secured at a position within a user&#39;s freeway space, the area of contact only contacting the teeth of the user&#39;s opposite arch when the user&#39;s jaw closes past the physiologic rest position. In some embodiments, the entire device may be rigid, or the entire device may be flexible, in which cases the device may or may not be formed from a single material. In other embodiments, the device does not necessarily have front and rear walls meeting to form an apex, resulting in a “V”-shaped profile to straddle the labial and lingual surfaces of the teeth to which it is mounted. Rather, a device according to the invention may be removably secured in place to a user&#39;s upper or lower incisors by any suitable means, including but not limited to thermoplastic forming, spring loading, cementation, thermoplastic resin molding, pressure fit, bonding, adhering, or friction fit. While a “V”-shaped profile may be desirable to obtain a good friction fit as illustrated in  FIGS. 1-5 , other means of securing the device in place do not necessarily require or benefit from the device being in contact with both the lingual and labial surfaces of the teeth to which the device is mounted. 
         [0039]    To illustrate certain variations that are possible within the scope of the invention, with reference to  FIGS. 6 and 7 , alternative devices  40  and  50  are depicted, which are secured only to the surface of the respective dental arch which faces the other dental arch. In particular, device  40  is an upper-mounted device that is essentially a unitary body  42  having an inner surface  44  secured to the lingual surface of upper incisors U and an outer surface  46  including a contact area  48  that generally faces lower incisors L. Device  40  as shown includes detents  49 , a preferred feature that aids in securing device  40  to upper incisors U with a suitable adhesive, cement, or bonding agent, for example. Analogously, device  50  is a lower-mounted device that is essentially a unitary body  52  having an inner surface  54  secured to the labial surface of lower incisors L and an outer surface  56  including a contact area  58  that generally faces upper incisors U. Device  50  is shown as including detents  59 . It will be noted that lower mounted device  50 , unlike upper mounted device  40 , extends over the incisal edge of the incisor to which it is mounted. This is because, for a normal jaw, the point of contact of jaw closure on the lower incisor is typically closer to the incisal edge than the point of contact on the upper incisor, which is typically toward the bottom of the lingual surface. Devices  40  and  50  may be retained on the respective tooth surface by cementation, bonding, or adhering, for example. Preferably, devices  40  and  50  are mounted to be removable by the user, but nonetheless securely enough to remain in place in the user&#39;s mouth through the user&#39;s nightly sleep, which is typically the time at which devices according to the present invention are most needed and most conveniently worn. 
         [0040]    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.