Abstract:
The invention is a three-contact-point dynamic scoliosis orthosis (DSO) brace to aid physicians treating scoliosis. A pelvic mold and two pads, one positioned above the apex of the spine curvature, the other positioned orthogonal to the apex of the spine curvature provide the anchor points on opposite sides of the curve. The pad orthogonal to the curve&#39;s apex is adjustable.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This nonprovisional utility patent application is a continuation-in-part of and claims the benefit under 35 USC §120 to co-pending U.S. patent application Ser. No. 12/150,475 filed Sep. 4, 2007, which is a continuation of and claims the benefit under 35 USC §120 to co-pending U.S. patent application Ser. No. 11/784,180 filed Apr. 4, 2007, which is a continuation of and claims the benefit under 35 USC §120 to co-pending U.S. patent application Ser. No. 11/588,188 filed Oct. 25, 2006, which is a continuation of and claims the benefit under 35 USC §120 to co-pending U.S. patent application Ser. No. 11/416,625 filed May 2, 2006, which is a continuation of and claims the benefit under 35 USC §120 to co-pending U.S. patent application Ser. No. 11/261,947 filed Oct. 28, 2005, which claims the benefit under 35 USC §119(e) to U.S. provisional patent application No. 60/623,073 filed Oct. 28, 2004, all of which are incorporated in their entirety by this reference with the following exception: In the event that any portion of the above-referenced applications is inconsistent with this application, this application supersedes said above-referenced applications. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to braces for use in scoliosis therapy. In particular, the present invention relates to the application of improved bracing to heal or assist in healing the scoliotic spinal curve of a patient having scoliosis. 
     BACKGROUND OF THE INVENTION 
     Apparatuses and methods for treating scoliosis have been practiced for many years. However, these generally involve heavy and bulky braces. Furthermore these braces tended to be so large and restrictive that patients had difficulty performing normal functions while wearing them, or found the braces so uncomfortable or embarrassing that patients refused to wear them. 
     Attempts to overcome these difficulties included cutting a hole in the brace material over the stomach to allow the wearer greater freedom to breathe. However many difficulties with the apparatus remained. 
     Traditional methods of using the brace are equally burdensome for users, and difficult for practitioners to implement. Braces used are not adjustable, have a closed design which increases the brace&#39;s weight and heat retention. 
     Furthermore, because braces are not adjustable, users have the same treatment whether asleep, when more aggressive treatment is possible, and awake, when more aggressive treatment is very painful. 
     SUMMARY OF THE INVENTION 
     The present invention teaches a method and apparatus for dynamic scoliosis orthosis. More particularly, the present invention teaches an apparatus for improving scoliosis treatment and therapy, as well as a method for making a brace and using a brace in treating patients with scoliosis. 
     Many other uses and advantages of the present invention will be apparent to those skilled in the art upon review of the detailed description of the preferred embodiments herein. Solely for clarity of discussion, the invention is described in the sections below by way of non-limiting examples. 
    
    
     
       DESCRIPTION OF DRAWINGS 
       In order that the advantages of the invention will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: 
         FIG. 1  is an isometric view of a first embodiment of the dynamic scoliosis orthosis (brace); 
         FIG. 2  is an orthographic rear view of a first embodiment of the dynamic scoliosis orthosis (brace); 
         FIG. 3  is a close-up view of the apical pad portion of  FIG. 2  with the adjustment key shown removed from the brace, and; 
         FIG. 4  is a substantially orthographic cross-sectional view of the rod portion of the brace taken at the location indicated by the section arrows in  FIG. 2 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     This specification describes exemplary embodiments and applications of the invention. The invention, however, is not limited to these exemplary embodiments and applications or to the manner in which the exemplary embodiments and applications operate or are described herein. 
       FIGS. 1 through 4  illustrate an exemplary embodiment of a Dynamic Scoliosis Orthosis or brace (or harness)  10 . Brace  10  comprises a rod  15 , a pelvic mold  30 , an auxiliary pad  40 , an apical pad  45 , an extension arm  50 , and an adjustment key  75 . Rod  15  may be made of a variety of materials or composite of materials including metals such as aluminum, carbon fiber, polymers or fibers and resins. Ideally the material selected will provide a rigid and stable support for the harness, thus providing steady force on the curved spine. The exemplary embodiment of the invention teaches a carbon fiber rod because it is light weight, flexible and still extremely strong. Rod  15  has a general elliptical cross-sectional shape so as to minimize the distance that rod  15  protrudes outwardly from the user&#39;s back, and so as to provide a greater resistance to bending in a lateral or side-to-side direction than in a fore-aft direction. Such difference in the resistance to bending provides for increased flexure mobility of the user of brace  10  and yet allows brace  10  to provide substantial scoliotic correctional loading to the spine of the user of brace  10 . The rod may be curved or straight, depending on what is best for the patient. The rod further comprises a first (upper) end  20  and a second (lower) end  25 . The present invention further teaches treating a double curved spine by enlarging the pelvic mold so as to extend further up the user&#39;s body. 
     First end  20  is coupled to pelvic mold  30  which contacts the user or wearer of brace  10  below the scoliosis curve of the user. Pelvic mold  30  is preferably custom fit for each wearer, and is formed from rigid polymers such as polypropylene. The custom fit of pelvic mold  30  maximizes the effectiveness of rod  15  by providing a tight and secure anchor for rod  15 . However, pelvic mold  30  may also be generically sized, and customized to fit snugly to the patient with inserts (not shown.) Inserts may also be used to improve the ease with which the present invention is cleaned. Optionally, pelvic mold  30  has a fastener  35  to aid the wearer in donning and removing the brace  10 . The fastener  35  may be a belt and buckle, hook and loop, or a friction mechanism. 
     Auxiliary pad  40  is coupled to second end  20  of rod  15  and contacts the user or wearer&#39;s body above the scoliosis curve of the user. Generally, auxiliary pad  40  is molded so as to cup the wearer&#39;s side and apply a load in the lateral direction on the wearer&#39;s spine. Auxiliary pad  40  is preferably formed from a rigid polymer, a metal, or a composite, selecting the materials best suited for the patient&#39;s need. Auxiliary pad  40  can be permanently coupled to the rod  15  using an epoxy, a mechanical mechanism or any other means known in the art. When permanently attached to rod  15 , auxiliary pad  40  preferably includes a removable and replaceable cover to improve the ease with which the pad is cleaned, replaced, or customized. However, auxiliary pad  40  may also be releasably coupled to rod  15  via a tab and sleeve configuration, or a non-permanent mechanical means known in the art. It is noted that auxiliary pad  40  may be replaced as the patient grows, or as the pad is worn out. 
     Extension arm  50  preferably includes an adjustment mechanism  55 , adjustable mount bracket  57 , guides  60 , and an adjustment key  75 . Extension arm  50  is adjustably coupled to the rod  15  between the ends  20  and  25  of rod  15  by means of adjustable bracket  57 . Apical pad  45  is extendably and retractably coupled to extension arm  50 . Apical pad  45  is similar in form and structure to auxiliary pad  40 , but is positioned to create a counter force to auxiliary pad  40  on the user&#39;s spine over the apex of the curvature of the user&#39;s spine. Thus at the contact point of apical pad  45 , a load is applied that is a counter load to the load applied by auxiliary pad  40  and pelvic mold  30 . The amount of load exerted by apical pad  45  is adjustable via adjustment mechanism  55 . Adjustment mechanism  55  may be any of a rack and pinion gear, a sliding lock, a toothed track secured by screws, or any other mechanism commonly known in the art. Removable adjustment key  75  engages into adjustment mechanism  55  and rotationally operates to adjust adjustment mechanism  55 . Alternatively, a knob or like adjust device may be integrally built into adjustment mechanism  55  to operatively adjust apical pad  45 . Adjustment mechanism  55  allows the user to increase the corrective load apical pad  45  exerts on the apex of the spine of the user to decrease the term of treatment of the user. Increasing the load is a common practice for patients, especially at night when the load can be greatly increased without severe discomfort to the user. Adjustment mechanism  55  is adjusted within guides  60  and according to setting marks  65  and  70 . Setting mark  65  preferably corresponds to a night time tension adjustment setting and setting mark  70  preferably corresponds to a day time tension adjustment setting. Setting marks  65  and  70  are preferably placed on apical pad  45  by a physician and are placed to maximize the effectiveness of the treatment. The invention also teaches adjusting the setting to minimize the pain caused by the treatment. The extension arm  50  may be made of metal, rigid polymer or a composite material. Furthermore, extension arm  50  may be coupled to rod  15  either permanently or non-permanently by selectively using means coupling means known in the art. Finally, extension arm  50  may be adjustable on rod  15  so as to provide multiple fixation points on rod  15 , thus allowing for periodic adaptation or fit of the user as the user grows. Such adaptation greatly reduces the cost of treatment by avoiding the need for the user to purchase multiple braces over time as the user grows. 
     Generally, because brace  10  has only three contact points, it has an open design, thus maximizing the freedom of motion of the user of the brace. The three-contact-points also minimize the amount of contact between the brace and the user, thus brace  10  is cooler and spares sensitive skin from excessive contact. For the purposes of this patent application it should be noted that the “three contact points” refer to the three principal load applying contact points. In the case of brace  10 , the first principal load applied in a first substantially lateral direction by auxiliary pad  40  is applied at a first contact point. The second principal load applied in a second substantially lateral direction (substantially opposing the first lateral direction) by apical pad  45  is applied at a second contact point. And the third principal load applied in the first substantially lateral direction (substantially opposing the second lateral direction) by pelvic mold  30  is applied at a third contact point. Any other loads and load points associated with brace  10  are substantially incidental to the described scoliosis correcting principal loads and principal load points. For the purpose of defining a benefit of brace  10  disclosed herein, the amount of surface area contact of the torso of the body of the user of brace  10 , the torso being understood to have an upper boundary of the user&#39;s neck and a lower boundary of the user&#39;s waist, divided by the total surface area of the torso of the body of the user of brace  10 , shall be understood to be a brace to torso contact ratio. In the disclosed embodiment, the brace to torso contact ratio is no more than 60%. In alternative embodiments, the brace to torso contact ratio is no more than 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5% and 3% respectively. Furthermore, the minimal nature of the invention reduces any embarrassment the user may feel because brace  10  can be concealed beneath clothing. Finally, the three-contact-points allow the wearer to breathe normally, without restricting chest expansion. 
     Referring now to  FIG. 4 , the elliptical cross-section of rod  15  functions to maximize the user&#39;s freedom of movement by allowing the user to bend forward and backward while still providing a load on the apex of the curve of the spine of the user. Brace  10  thus allows the wearer flexion and extension movements. 
     The modular design of brace  10  allows parts of brace  10  to be replaced and exchanged without having to replace the entirety of brace  10 . 
     Brace  10  may be fitted to treat either a right or left curved spine. 
     Benefits of the dynamic scoliosis orthosis (DSO) invention include: an adjustable tension loading that allows for individualized settings for different user tolerance and for periods of low force if there is pressure sensitive skin, respiratory distress, etc., an open design that is lighter than standard thorico lubo sacral orthosis (TLSO) and results in less heat retention and greater allowable chest expansion, a provision for flexion and extension motion of the user, daytime settings that simulate a standard scoliosis TLSO and night time settings that are comparable to the Charleston nighttime brace, a modular design that allows for component replacement, and modularity and variable tension settings that permit a single orthosis to be used for the duration of brace usage resulting in cost savings. It is noted that brace  10  is primarily intended for the correction of single scoliotic curves. However, especially with the addition of an enlarged pelvic girdle, double curves (extending pelvic high) could also be treated. 
     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.