Abstract:
A brace for stabilizing a joint such as a knee disposed between a first and second limb structure. The brace includes upper and lower frame members, cuffs for encompassing a portion of each limb structure, and a uniting pivoting joint member. The joint member includes two opposing pivoting assemblies, with each including a forward and a rearward arm member each having upper and lower ends spherically-pivotally connected to the upper and lower frame members for enabling multiple angular relationships. The pivoting assembly can include a limb extension regulator, preferably a cable, extending between the rearward arm member and the upper frame member to permit infinitely adjustable extendability of the brace-bearing limb. Most preferably, a visible measurement scale is provided for precise extension distances.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
   This application is a continuation-in-part of U.S. patent application Ser. No. 09/776,523, filed Feb. 2, 2001. 

   STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT 
   Not Applicable 
   BACKGROUND OF THE INVENTION 
   This invention relates in general to braces for joint support, and in particular to an exteriorly positionable anatomical brace having a pivoting joint assembly with multi planar hinging for accurate alignment of joined limb structures in relation to each other, and additionally having an infinitely-adjustable, cable-controlled limb extension regulator. 
   Both injury and disease can affect the health, well-being, and operability of various joints of the human body. Chief among such joints are the knee and elbow where disease such as osteo-arthritis can curtail normal activity or where an injury such as a sports-related abuse or impact can prevent or severely limit continued activity. One manner of treating such joint conditions and/or preventing or reducing the severity of sports related injuries is to fit the wearer with an appropriate brace whereby a pivotal support member is positioned adjacent the affected joint and held in place usually by cuffs situated around limb structure sites above and below the supported joint. As is apparent, the cuffs are responsible for stabilizing the support member and therefore must be well secured to their associated limbs. In addition to requiring proper limb structure embrace by cuffs, a joint brace also requires a joint pivoting assembly that supports, stabilizes, and protects the actual joint itself while pivotally joining the cuffs. Thus, in the knee joint for example, the joint pivoting assembly of the brace most beneficially should pivot in one bending or extension plane while also permitting multi planar motion such that the lower leg beneath the knee can be moved in a normal manner and the upper and lower leg structures can align with each other in a natural manner. Further, it many times is desirable to be able to precisely and infinitely limit or regulate the distance of the pivotal extension plane at the knee while allowing natural bendability and normal multi planar motion up to the controlled extension distance. Unfortunately, however, present braces generally are not able to offer multi-planar alignment capabilities or infinite extension control, thereby requiring a user to endure single-plane pivotability along with either a self-limit or pre-set limit of limb extendability. In view of such restrictions, it is apparent that a need is present for a joint brace that permits substantially natural limb movement in conjunction with limb extension control as indicated for particular limb care. 
   Consequently, a primary object of the present invention is to provide a joint brace having a joint assembly with multi planar hinging for accurate alignment of joined limb structures in relation to each other. 
   Another object of the present invention is to provide a joint brace having an infinitely-adjustable limb extension regulator for limiting limb extension as indicated for a particular user. 
   These and other objects of the present invention will become apparent throughout the description thereof which now follows. 
   BRIEF SUMMARY OF THE INVENTION 
   The present invention is an exteriorly positionable anatomical brace for stabilizing a uniting pivoting joint such as a knee joint disposed between a first and second limb structure of a living being. The brace comprises an upper frame member and a lower frame member joined together by a pivoting joint member, with each such frame member having secured thereon a respective cuff for encompassing a portion of each limb structure above and below the joint. Retention of the brace in place at the joint site is preferably accomplished with respective upper and lower securement members each wrapping around a respective limb structure in alignment with and not encompassed by the cuff. The pivoting joint member comprises two opposing pivoting assemblies each positionable on one side of the anatomical joint of a wearer to thus join the upper and lower frame members together. Each of these assemblies includes a forward arm member and a rearward arm member each having an upper end and a lower end, with these ends connected respectively to the upper frame member and the lower frame member. Specifically, the upper ends of each arm are individually mounted within a spherically-pivotal socket in connection with the upper frame member, while the lower ends of each arm likewise are individually mounted within a spherically-pivotal socket in connection with the lower frame member. As is apparent, these individual spherical mounts permit the selection of differing pivot ratios at a total of eight sites (four sites per lateral and per medial side) to thereby enable the upper and lower frame members to assume many different angular relationships with each other. Because of the availability of such a vast number of relationship combinations, the frame members of the brace becomes substantially self-aligning with each individual joint encounter among many wearers, thus accomplishing simulation of actual limb movement and angular interrelations thereof as natural individual limb-structure correlations are maintained. 
   As earlier noted, proper joint care many times requires limited or regulated limb extension, with such control emanating at the pivoting joint member. While prior art controls typically include inserts of a predetermined size for placement in the base path of upper and lower frame travel, the limb extension regulator of the present invention is a cable, preferably fabricated of braided metal strands, extending between each rearward arm member and the upper frame member. A cable-length adjuster, preferably externally accessible, is provided for infinitely adjusting the length of cable available between the arm member and frame member to thereby regulate extendability of the brace-bearing limb. Most preferably, a visible measurement scale is provided for each cable such that available cable length on each side of the joint is adjusted to be substantially identical. In addition to being infinitely length-adjustable, the cable additionally provides a modicum of elasticity such that cessation of limb travel produces a less dramatic limb impact, but, instead, a gentler limb-extension termination for the wearer. The brace here defined therefore substantially simulates natural joint behavior along with extension control as individually indicated. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     An illustrative and presently preferred embodiment of the invention is shown in the accompanying drawings in which: 
       FIG. 1  is a perspective lateral view of a knee brace with upper and lower cuffs of respective upper and lower frame members in place on a patient leg shown in phantom; 
       FIG. 2  is a perspective medial view of the knee brace of  FIG. 1 ; 
       FIG. 3  is a lateral perspective view of the upper cuff and upper frame member only of  FIG. 1  in disassociated relationship; 
       FIG. 4  is a medial perspective view of the upper cuff and upper frame member only of  FIG. 3 ; 
       FIG. 5  is a rear perspective view of the upper cuff and upper frame member of  FIG. 1  in place on a leg; 
       FIG. 6  is an interior perspective view of a portion of the upper cuff of  FIG. 1 ; 
       FIG. 7   a  is an interior side elevation view of the upper cuff of  FIG. 4 ; 
       FIG. 7   b  is a schematic interior side elevation view of the cuff of  FIG. 7   a  showing tensioning thereof; 
       FIG. 7   c  is a top plan view along line  7   c — 7   c  of  FIG. 7   a;    
       FIG. 8  is an inner perspective view of the joint assembly and respective portions of joined upper and lower frame members of  FIG. 1 ; 
       FIG. 9  is an exploded perspective view of the joint assembly and frame members of  FIG. 8 ; 
       FIGS. 10   a  and  10   b  are perspective views of the inner and outer sides of the joint assembly of  FIG. 8 ; and 
       FIG. 11  is an exploded perspective view of the joint assembly of  FIG. 10   a.   
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Referring first to  FIGS. 1-5 , a knee brace  10  is shown ( FIG. 1 ) in place on a leg  12  of a human being. The brace  10  has an upper frame member  14  and a lower frame member  16 , with each such frame member  14 ,  16  having secured thereon a respective cuff  18 ,  20  for disposition about the limb structures above and below the knee joint  22 . Each cuff  18 ,  20  is an arcuate wall structure, which non-limitedly can be fabricated of a polymer plastic, for juxtapositioning with the respective limb structures as shown. A snap-in protective patella cup  24  can be included as shown for specific impact absorption that may occur at the patella of the knee joint  22 . 
   The knee brace  10  is retained in place on the leg  12  with respective upper and lower securement members  26 ,  28  each respectively wrapping around an adjacent rear portion of the leg  12 . While  FIGS. 2-5  show only the upper securement member  26 , it is to be understood that the following description thereof applies equally to the lower securement member  28 . Thus, the securement member  26  includes a medial piece  30  and a lateral piece  32  each attached at outside edges thereof to an elastomeric central piece  34  disposed behind the medial and lateral pieces  30 ,  32 . Respective inside edges  40 ,  42  of the medial and lateral pieces  30 ,  32  are provided with eyelets  44  through which is intertwined a length of non-elastomeric lace  46  in substantially the same manner as a shoe is laced to thereby permit the drawing of each inside edge  40 ,  42  toward each other. As would be recognized by the skilled artisan, hook-and-loop connectors (e.g. VELCRO) or other appropriate engagers can be employed in place of the length of lace  46 . Finally, the elastomeric central piece  34  is secured along a generally central vertical length  48  thereof to a liner section (not shown) situated behind the central piece  34  to thereby permit elasticized movement of the medial and lateral pieces  30 ,  32 . 
   The lateral piece  32  is releasably secured respectively to the upper cuff  18  and the upper frame member  14 , and the medial piece  30  is releasably secured to the upper frame member  14  and the medial condyle  52 , all by way of respective quick-release tab members  54  situated within respective slots  56 . As shown, each tab member  54  is provided with a finger-receiving pressure button  58  which, when depressed, permits removal of the tab member  54  from the slot  56 . In operation, the brace  10  is placed at the limb site of a user and positioned about the involved limb structures. Upon first placement of the brace  10 , the lace  46  is tightened to appropriate tightness while the central piece  34  increases surface area on the leg  12  to disperse pressure and prevent pull from the leg  12  such that the cuff  18  is properly maintained in place. Once such lacing is accomplished the first time, re-lacing is not required during brace use. Specifically, when a user wishes to remove the brace, the user simply presses inwardly on the pressure buttons  58  of only laterally, or, preferably, only medially, situated tab members  54  to release these tab members  54  from their respective slots  56  and remove the brace  10  from the leg  12 . It is important to note that the above-described tab-member release does not require increased tension on the leg and therefore is both safe and comfortable. Subsequent re-positioning of the brace  10  merely requires placement thereof as previously situated and re-connection of the earlier disengaged tab members  54  into respective slots  56 . This re-connection requires no contact with, or re-adjustment of, the lace  46  or the central piece  34 , and thereby assures proper brace placement without awkward, and very possibly incorrect, orientation of the brace  10 . Because the medial connection involves connection to the medial condyle  52  which is, of course, at the hinge point of the upper and lower frame members  14 ,  16 , a closer positioning of the securement member  26  to the body joint is permitted, thereby improving joint support. While a lateral condyle  60  does not bear a connector member, it is to be understood that such construction could be provided if desired. 
   Construction of the cuffs  18 ,  20  is illustrated in  FIGS. 6-7   c . Both the upper cuff  18  and lower cuff  20  are substantially identical in construction except for overall size since, of course, the lower cuff  20  encompasses a smaller-diameter limb portion below the knee joint  22 . As shown particularly in  FIGS. 6 and 7   a  with respect to the upper cuff  18 , whose following description also applies to the lower cuff  20 , the cuff  18  has two tensioning strip members  62 , integral therewith and disposed within respective non-continuous sleeves  64 ,  66  that are structurally a part of the cuff  18  and that converge toward each other medially. Each strip member  62 , which preferably is fabricated of titanium, stainless steel, or similar material possessing similar tensioning properties, continues medially into a cuff mount  68  that functions to secure the cuff  18  to the upper frame member  14 . Finally, a respective exteriorly-accessible threaded screw  70  extends into each strip member  62  for adjusting tension in each strip member  62  and simultaneously adjusting the arc defined by the upper cuff  18 . Thus, clockwise turning of the screw  70  incrementally draws the lateral end of the strip member  62  medially for arcuately tightening the cuff  18 , while counter clockwise turning of the screw  70  incrementally releases the lateral end of the strip member  62  for arcuately loosening the cuff  18 . Operationally, the brace  10  is fitted to a patient by encompassing the cuffs about the respective limb structures above and below the knee joint  22  as seen in FIG.  1 . Once the upper cuff  18  is situated about the limb structure, the screws  70  are threadingly advanced to thereby cause movement of the lateral end of the cuff  18 , as illustrated in  FIGS. 7   b  and  7   c , against the limb structure as the strip members  62  are forced to bend toward the encompassed limb structure. Continued screw advancement increases tightening of the cuff  18  against the encompassed limb structure to thereby accomplish superior anchoring of the brace  10  and consequent stabilization of the knee joint  22 . As earlier noted, the lower cuff  20  is constructed in the same manner as the upper cuff  18  and therefore encompasses and embraces the limb structure below the knee joint  22  in like fashion. 
   Referring to  FIGS. 8-11 , the pivoting assembly  72  uniting the upper and lower frame members  14 ,  16  is illustrated. The assembly  72  includes an upper housing  74  and a lower housing  76  that fit, respectively, into a complementarity shaped opening  78  of the upper frame member  14  and a complementarity shaped opening  80  of the lower frame member  16 . Once so positioned, respective caps  82 ,  84  are held in place with conventional set screws  86  passing respectively through apertures  88   a ,  88   b  and  90   a ,  90   b . Those skilled in the art however will recognize that the housings  74  and  76  can be formed unitary with the frame members  14  and  16 . The lateral condyle  60  resides between the assembly  72  and the knee joint  22 . Both the upper and lower housings  74 ,  76  have two respective openings  92   a ,  92   b  and  94   a ,  94   b  each having respective sidewalls  96  shaped to nest a spherical shape. Disposed between two openings  92   b ,  94   a  of the housings  74 ,  76  is a forward arm member  98  having generally perpendicularly angled first and second ends  100   a ,  100   b  directable toward the openings  92   b ,  94   a . In like manner, a rearward arm member  102  having generally perpendicularly angled first and second ends  104   a ,  104   b  is disposed between two openings  92   a ,  94   b  of the housings  74 ,  76  such that the ends  104   a ,  104   b  are directable toward the openings  92   a ,  94   b . A cable assembly  106  includes a cable  108  extending from the upper housing  74  to an upper edge portion  110  through an aperture  112  of the rearward arm member  102 , and is provided with a conventional set screw  114  at one end thereof for extending or shortening the length of the cable  108  disposed between the rearward arm member  102  and upper housing  74 . Such length adjustment is accomplished with an Allen wrench inserted into the enterable channel  116  leading to the set screw  114 . Because the upper housing  74  resides within the upper frame member  14 , the cable  108  functions as a joint extension limiter to determine the travel distance of the upper frame member  14  from the joint and thus the pivotal distance of the upper and lower frame members  14 ,  16  in relation to each other. An opening  126  can be provided in the cap  82  such that the progressive placement of the cable  108  can be observed exteriorly and such placement can be made identical for both the lateral and medial sides. Two additional benefits are provided by the cable  108  in that, first, infinite pivot-distance adjustability, as opposed to prior-art pre-sized stop members, allows great flexibility in leg extension, and, second, the cable itself has a dampening, or minimal stretch, effect that results in a softer extension stop and a consequent reduced risk of joint trauma. 
   As earlier described, the sidewalls  96  of the openings  92   a ,  92   b  and  94   a ,  94   b  are shaped to nest spherical forms. As clearly illustrated in  FIG. 11 , spherical sockets  118   a ,  118   b,    118   c ,  118   d  are disposed in these openings  92   a ,  92   b  and  94   a ,  94   b  in the constructed assembly  72 , and each such socket accepts one respective perpendicularly angled end of forward and rearward arm members  98 ,  102 . Each angled end  100   a ,  100   b ,  104   a ,  104   b  has an aperture  120  there through which mates with a transverse aperture  122  of each socket  118   a ,  118   b ,  118   c ,  118   d  such that respective pins  124  can pass through such mated apertures and retain the angled ends  100   a ,  100   b ,  104   a ,  104   b  within the sockets  118   a ,  118   b ,  118   c ,  118   d . Because of the spherical interface between each socket  118   a ,  118   b ,  118   c ,  118   d  and each sidewall  96 , multi planar movement of the upper and lower frame members  14 ,  16  in relation to each other can be accomplished. In particular, the different pivot points thus provided allow different pivot ratios as needed for both lateral and medial sides to thereby simulate actual knee joint movement. This is, of course, in contrast to parallel planar hinges as found in the prior art where the knee joint and limb structures of a user are forced to adapt to knee brace construction instead of the knee brace adapting to the needs of the user. The present knee brace  10 , because of the multi planar and potentially differing pivot ratios and consequent multi planar movement capabilities of the lower frame member  16  in relation to the upper frame member  14 , provides automatic tibia alignment and automatic anatomical changes over time by accommodating anatomical differences among users. These properties accomplish all-important positive three-point positioning at the quadriceps muscle, the gastrocnemius (calf) muscle, and the knee joint itself. In this manner, stabilization and support of a uniting pivoting joint occurs economically, through an “off-the-shelf” brace, and, simultaneously, most effectively through continual self-alignment capabilities combined with sound limb-structure stability. 
   While an illustrative and presently preferred embodiment of the invention has been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed and that the appended claims are intended to be construed to include such variations except insofar as limited by the prior art.