Abstract:
A highly adaptable compression apparatus to apply a compression force to an extremity of a user. The apparatus includes a removable compression overlay to selectively adhere to a compression sheath surrounding an extremity of a user. A plurality of independently adjustable straps may be coupled to the compression overlay. Tightening the straps may contract the compression overlay to tighten the compression sheath around the extremity, thereby increasing a hydrostatic compression force imparted thereto

Description:
RELATED APPLICATIONS  
       [0001]     This application claims priority to U.S. Provisional Patent App. No. 60/803,222, filed on May 25, 2006, and entitled CUSTOMIZABLE COMPRESSION ORTHOSIS. 
     
    
     BACKGROUND  
       [0002]     1. Field of the Invention  
         [0003]     This invention relates to orthopedic devices, and more particularly to an orthopedic compression brace to apply a hydrostatic compression force to an extremity of a user.  
         [0004]     2. Background  
         [0005]     Functional fracture bracing is premised on the engineering principle of hydrostatic compression. Specifically, compressing the soft tissue around the bone produces increased intra-vascular hydrostatic pressure to stabilize the fracture and promote healing. The increased hydrostatic pressure created by the brace shifts the load that would be borne in the bone to the surrounding soft tissue, such that the soft tissue has a greater load-bearing effect than the brace itself. A rigid exterior frame may also be implemented to further stabilize the injury.  
         [0006]     Fracture orthoses are advantageous over traditional rigid casting in many ways. Particularly, fracture orthoses are easily applied by a skilled physician or other professional. The speed of application can be a great asset in the trauma setting, as it enables the physician or other professional to manage multiple patients and perform any necessary adjustments quickly and easily. Fracture orthoses may also be easily adjusted to accommodate changes in the volume of the fractured extremity over time. In this manner, fracture orthoses may promote healing by maintaining hydrostatic pressure to stabilize the fractured bone as the volume of the affected limb decreases due to atrophy, or increases due to swelling. Fracture orthoses are also readily removable to enable effective hygiene management, and are generally more economic than traditional casts.  
         [0007]     Many known fracture orthoses, however, are disadvantageous to patients that would benefit from light to moderate activity, such as stress fracture patients. Indeed, such fracture orthoses are generally too cumbersome and rigid to permit the movement required for such activity. Accordingly, recent developments in stress fracture treatment include stirrup-style pneumatic ankle control braces. Even these braces, however, present certain drawbacks.  
         [0008]     Specifically, some stress fracture orthoses exert medial-lateral compression force to effectuate increased hydrostatic pressure, and are thus less effective in stabilizing a fracture than orthoses that provide circumferential compression force. Known stress fracture orthoses are also generally bulky and may be awkward to wear. For example, as previously mentioned, some lower leg orthoses require a stirrup underneath the foot that may create discomfort.  
         [0009]     Also, known stress fracture orthoses, as well as fracture orthoses generally, are size-specific. This feature necessitates manufacture and storage of substantial quantities of orthoses in a wide range of sizes—some of which may never be used. Similarly, known orthoses are also generally specific to the right and left sides of a user&#39;s body, further contributing to an oversupply of orthoses and, inevitably, waste.  
         [0010]     Accordingly, what is needed is a highly effective orthosis that exerts circumferential compressive force to effectuate increased hydrostatic pressure to stabilize a fracture. Further what is needed is an orthosis that is comfortable to wear and permits light to moderate activity. Also what is needed is an orthosis that is compact to store. Finally what is needed is a customizable orthosis that may be sized to a particular user, implemented on either a right or left extremity, and that substantially conforms to the user&#39;s body.  
         [0011]     Such an orthosis is disclosed and claimed herein.  
       SUMMARY  
       [0012]     The present invention has been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been met for applying a hydrostatic compression force to an extremity of a user. Accordingly, the present invention has been developed to provide an apparatus, system and method for applying a compression force to an extremity of a user that overcomes many or all of the above-discussed shortcomings in the art.  
         [0013]     A highly adaptable compression apparatus to apply a compression force to an extremity of a user in accordance with the present invention may include a compression overlay having a cinching mechanism coupled thereto. The compression overlay may selectively adhere to a compression sheath substantially surrounding an extremity of a user. The cinching mechanism may be tightened to contract the compression overlay, thereby tightening the compression sheath around the extremity. In this manner, the present invention may increase a hydrostatic compression force imparted to the extremity.  
         [0014]     In some embodiments, the compression overlay includes more than one elongated mounting panel to mount the compression overlay to the compression sheath. A distance between the mounting panels may be adjusted to accommodate various users. In one embodiment, the mounting panels include hook and loop-type fastening elements to mount the compression overlay to the compression sheath. Further, one or more substantially rigid stays may be longitudinally integrated into the compression overlay to increase stability of the extremity.  
         [0015]     In certain embodiments, the cinching mechanism of the present invention includes a cam-over device, such as straps or laces. In one embodiment, the cam-over device includes a plurality of straps. Each strap includes a primary looped portion fixed to the compression overlay, and a secondary portion slidably connected to the primary looped portion. The primary looped portion may be fixed to one mounting panel of the compression overlay and slidably connected to another mounting panel. In some embodiments, the secondary portion removably attaches the secondary portion to the compression sheath.  
         [0016]     A system of the present invention is also presented to apply a compression force to an extremity of a user. The system may include a unitary compression sheath to substantially surround an extremity of a user. The unitary compression sheath may include a resilient portion to apply a hydrostatic compression force to the extremity, and an elastic portion to facilitate application and removal of the compression sheath. The system may further include a removable compression overlay to selectively adhere to the compression sheath. A cinching mechanism coupled to the overlay may contract the compression overlay upon tightening, thereby tightening the compression sheath around the extremity and increasing a hydrostatic compression force imparted thereto.  
         [0017]     In some embodiments, the compression sheath may include longitudinal seams connecting the resilient portion to the elastic portion. These seams may facilitate positioning of the compression sheath with respect to the extremity. Longitudinal folds may extend from the longitudinal seams and be adapted to reduce pressure and irritation over bony prominences of the extremity.  
         [0018]     A method to apply a compression force to an extremity of a user may include positioning a compression sheath around an extremity of a user and applying a removable compression overlay to the compression sheath. A cinching mechanism coupled to the compression overlay may be tightened to contract the compression overlay, thereby tightening the compression sheath around the extremity. The cinching mechanism may then be secured to increase a hydrostatic compression force imparted to the extremity. Further, in some embodiments, substantially rigid stays integrated into the compression overlay may be selectively positioned to increase stability of the extremity.  
         [0019]     In one embodiment, applying the removable compression overlay may include mounting a first mounting panel of the overlay to the compression overlay. A second mounting panel of the overlay may be adjusted relative to the first mounting panel as needed to accommodate a particular extremity. The second mounting panel may then be mounted to the compression sheath.  
         [0020]     These and other features and advantages of the present invention will be set forth or will become more fully apparent in the description that follows. The features and advantages may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. Furthermore, the features and advantages of the invention may be learned by the practice of the invention or will be obvious from the description, as set forth hereinafter.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0021]     In order that the manner in which the above-recited and other advantages and features of the invention are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered 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:  
         [0022]      FIG. 1  is a front view of one embodiment of an adaptable compression orthosis in accordance with the present invention;  
         [0023]      FIG. 2  is a perspective view of one embodiment of an adaptable compression orthosis applied to a lower leg of a user in accordance with the present invention;  
         [0024]      FIG. 3  is a perspective view of an alternative embodiment of an adaptable compression orthosis in accordance with the present invention;  
         [0025]      FIG. 4  is a front view of one embodiment of a compression sheath that may be used in conjunction with an adapatable compression orthosis in accordance with the present invention;  
         [0026]      FIG. 5  is a perspective view of the compression sheath of  FIG. 4  fitted to a lower leg of a user; and  
         [0027]      FIG. 6  is a flow chart detailing steps for applying a compression force to an extremity of a user in accordance with embodiments of the present invention.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0028]     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 that come within the meaning and range of equivalency of the claims are to be embraced within their scope.  
         [0029]     The presently preferred embodiments of the invention will be best understood by reference to the drawings wherein like parts are designated by like numerals throughout.  
         [0030]     As used in this specification, the term “orthosis” refers to an externally applied device used to modify the structural and/or functional characteristics of a limb or other extremity. The term “user” refers to any human or animal utilizing an orthosis to stabilize an extremity or other portion of the body as described herein.  
         [0031]     Referring now to  FIG. 1 , an adaptable compression orthosis  100  in accordance with the present invention may comprise a compression overlay  102  to selectively adhere to a compression sheath (not shown). The compression overlay  102  may be unitary or modular in design and may include one or more mounting panels  104  to mount the compression overlay  102  to the compression sheath. In one embodiment, for example, the mounting panels  104  include a hook and loop fastener, such as Velcro®, to mount the compression overlay  102  to the compression sheath.  
         [0032]     A distance  106  between the mounting panels  104  may be adjusted as needed to fit a particular user. For example, the distance  106  may be shortened to accommodate an extremity having a larger circumference, and lengthened to accommodate an extremity having a smaller circumference. The distance  106  between the mounting panels  104  may also be adjusted along a length of the compression overlay  102  to accommodate circumferential variances along an extremity. For example, in a lower leg application, the distance  106  between mounting panels  104  may be shortened at the widest part of the calf and lengthened towards the ankle. This adjustability may also enable the compression overlay  102  of the present invention to be used in connection with various compression sheaths having varying topographies and contours.  
         [0033]     The compression overlay  102  may further include a cinching mechanism  108  attached to the mounting panels  104 . The cinching mechanism  108  may include a cam-over device such as straps, laces, or any other such device known to those in the art. In operation, the cinching mechanism  108  may contract the compression overlay  102  upon tightening, thereby tightening the compression sheath around an extremity of a user. As a result, the hydrostatic compression force imparted to the extremity may be increased.  
         [0034]     In one embodiment, the cinching mechanism  108  includes straps having a primary looped portion  112  fixed to the compression overlay  102 , and a secondary portion  114  slidably connected to the primary looped portion  112 . Alternatively, each strap may include a unitary or other modular design. The straps may include any natural or synthetic material known to those in the art. The primary looped portion  112  may be fixed to the compression overlay  102  by a fastening device  116  such as a ring, a clasp, a seam, a snap, a rivet, or the like. The secondary portion  114  may be slidably connected to the primary looped portion  112  via a connecting device  118 , such as a slidable ring.  
         [0035]     In one embodiment, the primary looped portion  112  is attached to multiple mounting panels  104   a,    104   b  of the compression overlay  102 . The primary looped portion  112  may be fixedly connected to one mounting panel  104   a  with rivets  116   a ,  116   b , and slidably connected to another mounting panel  104   b  with rings  116   c ,  116   d  to facilitate tightening the cam-over device  108  to contract the compression overlay  102 . In one embodiment, the fastening devices  116   c ,  116   d  used to attach the primary looped portion  112  to the second mounting panel  114   b  are flexibly attached to the second mounting panel  114   b  to accommodate minor circumferential variation due to muscle flexion and the like.  
         [0036]     The secondary portion  114  may include a removable fastening device (not shown) to secure the cam-over device  108  relative to the compression sheath, thereby maintaining the hydrostatic compression force imparted to the extremity. In one embodiment, for example, the secondary portion  114  may include a hook and loop fastening device, such as Velcro®, to secure the cam-over device  108  relative to the compression sheath. Alternatively, the secondary portion  114  may include a buckle, a snap, a hook, a loop, or any other device known to those in the art to secure the cam-over device  108  relative to the compression sheath.  
         [0037]     Removably securing the cam-over device  108  relative to the compression sheath may enable customized application of the hydrostatic compression force to the extremity. Moreover, in some embodiments, variable distance between mounting panels  104  and adjustable securement of the cam-over device  108  with respect to the compression sheath combine to enable the present invention to provide a uniquely high level of adaptability.  
         [0038]     In some embodiments, the compression overlay  102  may further include one or more substantially rigid stays  110  to further stabilize an affected extremity. The stays  110  may be longitudinally integrated into one or more of the mounting panels  104  to provide increased load-bearing support while avoiding interference with the adjustability and function of the present invention.  
         [0039]     Referring now to  FIG. 2 , the compression overlay  102  may be selectively attached to a compression sheath  200  and oriented to facilitate a user&#39;s ability to tighten the cam-over device  108  to apply a desired amount of hydrostatic compression force to an extremity. Moreover, in embodiments where the compression overlay  102  is entirely removable, an adaptable compression orthosis  100  in accordance with the present invention may not be side-specific, but may be implemented on either a right or left extremity.  
         [0040]     In one embodiment, for example, the compression overlay  102  may be mounted to the compression sheath  200  and situated at the front of a user&#39;s lower leg. The user may mount one mounting panel  104   a  substantially parallel to the tibia, or shin bone, and adjust a distance  106  between the mounting panel  104   a  and a second mounting panel  104   b  as needed to accommodate the lower leg. In some embodiments, the first mounting panel  104   a  may be substantially permanently attached to the compression sheath  200 , while the second mounting panel  104   b  may be removably attached thereto.  
         [0041]     Upon securing the second mounting panel  104   b  to the compression sheath  200 , the user may grasp the secondary portion  114  of the cam-over device  108  and pull it laterally towards the first mounting panel  104   a . In this manner, the secondary portion  114  of the cam-over device  108  may reverse over the primary looped portion  112  to cinch the mounting panels  104   a ,  104   b  together, thereby contracting the compression overlay  102 .  
         [0042]     The secondary portion  114  of the cam-over device  108  may be removably secured to the compression sheath  200  by way of a hook and loop fastening device, such as Velcro®, or by any other means known to those in the art. Alternatively, the cinching mechanism  108  may be secured to the compression overlay  102 , and/or may be secured by an independent securing device. An independent securing device may include, for example, a knot, a bow, a clasp, a cinch, or any other suitable securing device known to those in the art. In this manner, the user may tighten and secure the compression sheath  200  around the lower leg to increase a hydrostatic compression force imparted thereto.  
         [0043]     Referring now to  FIG. 3 , an alternative embodiment of the cinching mechanism  108  may include laces  300  extending between opposing sides of the compression overlay  102 . In one embodiment, the laces  300  may extend between two mounting panels  104   a ,  104   b . Specifically, each mounting panel  104  may include multiple eyelets  302  through which the laces  300  are threaded. Tightening the laces  300  may cinch the mounting panels  104  together, thereby contracting the compression overlay  102  to tighten the compression sheath  102  around an affected extremity. The laces  300  may be secured by a knot, a bow, a clasp, or any other means known to those in the art.  
         [0044]     In some embodiments, as mentioned above, the laces  300  or other cam-over device  108  may cooperate with multiple mounting panels  104  to facilitate a customized application of hydrostatic compression force to an extremity. Indeed, while a distance  106  between mounting panels  104  may be adjustable, a user may be limited in his ability to manually increase this distance  106  to tighten the compression sheath  200  around the extremity. Accordingly, the laces  300 , straps, or other cam-over device  108  provide additional leverage to enable the user to easily and effectively tighten the compression sheath  200  around the extremity to increase the amount of hydrostatic compression force imparted thereto.  
         [0045]     Referring now to  FIGS. 4 and 5 , one embodiment of an adaptable compression orthosis  100  in accordance with the present invention includes a unitary compression sheath  200  to substantially surround an extremity of a user. The unitary compression sheath  200  may include a resilient portion  400  and an elastic portion  402 . The resilient portion  400  may apply a hydrostatic compression force to the extremity, while the elastic portion  402  may facilitate application and removal of the compression sheath  200 .  
         [0046]     The resilient portion  400  may be adapted to substantially evenly distribute a circumferential compression force to stabilize an extremity. In some embodiments, the resilient portion  400  may include a flexible, substantially resilient material such as Neoprene®, foam rubber, plastic, nylon, or other suitable material known to those in the art. The resilient portion  400  may further include multiple layers to facilitate application and maintenance of a hydrostatic compression force.  
         [0047]     In one embodiment, for example, the resilient portion  400  includes an outer layer  408  including a hook and loop fastening device such as Velcro®. This may enable the outer layer  408  to cooperate with the secondary portion  114  of the cinching mechanism  108  to secure the same. The resilient portion  400  may further include an inner layer  410  to mediate contact between the resilient portion  400  and the user&#39;s skin. The inner layer  410  may include a breathable material to improve circulation, reduce perspiration, and/or increase overall comfort. In some embodiments, the resilient portion  400  may further include one or more seams (not shown) and/or substantially collapsible sections to facilitate compact storage.  
         [0048]     The elastic portion  402  of the compression sheath  200  may enable the compression sheath  200  to be applied over a foot, hand or other intermediary appendage of a user to substantially surround an affected extremity. In certain embodiments, for example, the elastic portion  402  may include Lycra®, Spandex®, nylon, or any other suitable elastic material known to those in the art.  
         [0049]     In some embodiments, the elastic portion  402  may be attached to the resilient portion  400  via longitudinal seams  404  extending from a top  412  to a bottom  414  of the compression sheath  200 . In one embodiment, the seams  404  are integrated to create longitudinal folds  406  in the resilient portion  400  that extend beyond the edges  416   a ,  416   b  of the elastic portion  402 .  
         [0050]     The longitudinal folds  406  may be positioned substantially laterally of a bone or bony prominence to reduce friction and pressure over the same. In this manner, the longitudinal folds  406  may bridge an applied hydrostatic compression force over sensitive areas to avoid skin irritation and pressure, while nevertheless imparting a substantially circumferential compression force to stabilize an affected extremity.  
         [0051]     In some embodiments, the compression sheath  200  may include dimensions sufficient to accommodate a wide range of users. For example, in one embodiment, a compression sheath  200  for lower leg use in accordance with the invention includes small, medium narrow, medium wide, large narrow, and large wide sizes. These sizes are adapted to accommodate various users depending on lower leg length and calf circumference.  
         [0052]     Referring now to  FIG. 6 , a method  600  to apply a compression force to an extremity of a user in accordance with the present invention may include positioning  602  a compression sheath to substantially surround an extremity of a user and applying  604  a removable compression overlay to the compression sheath.  
         [0053]     In some embodiments, the compression panel may include more than one mounting panel. A first mounting panel may be removably attached  606  to the compression sheath, or may be substantially permanently attached  606  thereto. A second mounting panel may be adjusted  608  relative to the first mounting panel as needed to accommodate an affected extremity of a particular user. The second mounting panel may then be removably attached  610  to the compression sheath.  
         [0054]     A cinching mechanism attached to the compression overlay maybe tightened  612  to contract the compression overlay, thereby tightening the compression sheath around the extremity. The cinching mechanism may then be secured  614  to increase a hydrostatic compression force imparted to the extremity.  
         [0055]     In some embodiments, the cinching mechanism may be secured to the compression sheath. Alternatively, the cinching mechanism may be secured to the compression overlay, and/or may be independently secured by a securing device. A securing device may include, for example, a knot, a bow, a clasp, a cinch, or any other suitable securing device known to those in the art.  
         [0056]     In some embodiments, a method  600  in accordance with the present invention may further include positioning (not shown) a substantially rigid stay of the compression overlay to increase stability of the extremity. Specifically, one or more substantially rigid stays may be positioned to increase load-bearing support with respect to the affected extremity.  
         [0057]     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.