Abstract:
An adjustable knee brace for immobilization of a patient&#39;s knee in multiple adjustment angular inclinations for use in therapeutic applications. The knee brace has a sheet of cushion material which is adapted to be wrapped about and secured to the patient&#39;s leg by a pair of interconnected rigid upper and lower leg engagement plates and associated straps. The leg engagement plates are determined to be registerably engaged against the medial aspect of the leg above and below the knee and have adjustable articulated locking interconnecting hinge and pivot fitting assemblies extending therebetween for both saggital and frontal plane brace adjustment. An independent knee engagement pad provides knee stabilization in cooperation with leg engagement plates.

Description:
This is a continuation in part patent application of Ser. No. 10/694,749, filed Oct. 29, 2003, now U.S. Pat. No. 7,011,641. 

   BACKGROUND OF THE INVENTION 
   1. Technical Field 
   This invention relates to knee braces more particularly to a securing apparatus to immobilize the knee joint of a human. In therapeutic treatment of the knee which includes surgery and joint replacement it is often required to stabilize the knee there after to unload the effective ligaments to impart medial and lateral stability to the knee for a precise period of time for healing. 
   2. Description of Prior Art 
   Prior art devices of this type have been used to stabilize and immobilize the knee are directed to a variety of knee brace configurations which are secured to the leg above and below the knee with a mechanical support linkage there between, see for example U.S. Pat. Nos. 4,407,276, 5,135,469, 5,823,931, 5,873,847, 6,461,318. 
   An articulated knee brace is illustrated in U.S. Pat. No. 4,407,276 illustrating an upper and lower leg engagement cuff with bi-lateral interconnecting elastic strap and a knee pad extending over the expose knee cup. 
   U.S. Pat. No. 5,135,469 is directed to a post surgical knee brace which incrementally is adjustable. The brace has pairs of upper and lower struts interconnected by a pair of oppositely disposed ratio-swing hinges which allow for incremental angularly bi-lateral adjustments. 
   A knee brace is described in U.S. Pat. No. 5,823,931 in which an upper and lower leg engagement arms are secured to the leg above and below the knee. A bisymmetric hinge interconnects the arms and has a pair of attachment levers extending there from, each with its own pivot access in vertically aligned and spaced relation to one another. 
   U.S. Pat. No. 6,561,318 claims an anatomical brace with rapid release securement members for protecting a uniform pivoting joint is disposed between the respective limb engagement members. 
   An orthopedic splint can be seen in U.S. Pat. No. 5,873,847 disclosing a pair of end plates interconnected by continuous adjustable straps to limit flexing and extension with a spring to pre-load same. 
   Exhibit A and B are set forth below illustrating catalog sheets which refer to the prior art disclosure. 
   Exhibit A is a catalog sheet from Alimed, Inc., page BQ53 illustrates a number of different immobilizer/and stabilization devices for knees having a variety of posterior medial and lateral stops with contoured leg wraps and adjustable bi-lateral hinge assemblies. 
   Exhibit B is a catalog sheet from PEL illustrating a number of default knee immobilizers utilizing wrap around fabric panels with interdisposed splints and deformable support stays as an example of the currently available immobilizations in the market place. 
   SUMMARY OF THE INVENTION 
   An articulated adjustable knee immobilizer brace having a flexible wrap around fabric sheet with selectively attached upper and lower interconnected leg engagement plates. Each of the leg engagement plates has multiple non-elastic adjustable straps extending there from for securing the brace to the patient&#39;s leg. An incrementally adjustable locking hinge assembly between the leg engagement plates and a longitudinal pivot fitting allows for selective multi-angular leg position adjustment dependent on the therapeutic positions so required. An independent knee engagement restraint is adjustably positioned from the respective leg engagement plates providing additional support to the knee. 

   
     DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a modified side elevational view of the knee brace of the invention on a portion of a patient&#39;s leg; 
       FIG. 2  is a front elevational view thereof; 
       FIG. 3  is a rear elevational view thereof; 
       FIG. 4  is a side elevational view of the knee brace of the invention on a portion of a patient&#39;s leg in angular adjusted position illustrating the range of adjustment; 
       FIG. 5  is a rear elevational view of the knee brace of the invention before placement around a patient&#39;s leg; 
       FIG. 6  is a partial side elevational view of a leg engagement plate and hinge engagement extension of the invention; 
       FIG. 7  is an enlarged partial rear elevational view of the hinge assembly; 
       FIG. 8  is a cross-sectional view on lines  8 — 8  of  FIG. 5 ; 
       FIG. 9  is rear elevational view of the leg engagement plate illustrated in  FIG. 6  of the drawings; 
       FIG. 10  is an enlarged side elevational view of the hinge assembly of the invention; 
       FIG. 11  is a side elevational view of a leg attachment strap; 
       FIG. 12  is a modified side elevational view of a leg attachment strap extension interengaged on the strap shown in  FIG. 11 ; 
       FIG. 13  is a side elevational view of the knee brace of the invention on a patient&#39;s leg with an alternate longitudinal pivot adjustment fitting thereon; 
       FIG. 14  is a rear elevational view of the knee brace of the invention before placement around a patient&#39;s leg with the alternate pivot adjustment thereon; 
       FIG. 15  is an enlarged partial rear elevational view thereof; and 
       FIG. 16  is an enlarged partial sectional view of the hinge and pivot fitting of the alternate form of the invention. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENT 
   Referring to  FIGS. 1–3  of the drawings, a knee immobilization brace  10  can be seen positioned over a portion of a patient&#39;s leg  11  and knee  12 . The brace  10  has a flexible sheath  13  of cushion material disposed to be wrapped around the patient&#39;s leg  11  extending above and below the knee. Attached to the flexible sheath  13  by inter-engaging hook and loop material H and L is a pair of interconnected contoured leg engagement plates  14  and  15  which are vertically aligned in spaced relation to one another. Each of the leg engagement plates  14  and  15  are generally of a rectangular configuration having a central longitudinally extending recessed channel portions  16 A and  16 B respectively therein, as best seen in  FIGS. 3 ,  4  and  8  of the drawings. 
   A plurality of strap mounting slots can be seen at  17 A and  17 B formed within the respective leg engagement plates  14  and  15  in oppositely disposed relation to one another on either side of the respective channel areas  16 A and  16 B, best illustrated in  FIG. 3  of the drawings. The respective slots  17 A and  17 B orientation is such that a variety of different strap mounting positions on the leg engagement plates  14  and  15  can be achieved with adjacent parallel slot pairs  18 A and  18 B and  19 A and  19 B in horizontally spaced relation thereto on respective leg engagement plates  14  and  15 . 
   The leg engagement plates  14  and  15  are transversely contoured to conform with the medial leg portion with engagement above and below the knee  12  as best seen in  FIGS. 4 ,  6  and  7  of the drawings. 
   Referring now to  FIGS. 3 ,  4  and  10  of the drawings, an adjustable hinge assembly  20  can be seen having an upper leg element  21  and a lower leg element  22  extending there from, both comprised of metal alloys or other suitable material. The upper leg element  21  is adjustably secured within the recess channel  16 A of the upper leg engagement plate  14  by multiple fasteners F as will be described in detail hereinafter, with an articulated curved free end at  23 . The lower leg element  22  is correspondingly secured within the recess channel  16 B of the lower leg engagement plate  15  by fasteners F and also has an articulated curved free end at  24 . 
   The articulated curved free ends  24  and  25  of the respective upper and lower leg elements  21  and  22  have spaced parallel adjustment slots S within that overlie one another when so engaged for aligned registration as seen in  FIG. 10  of the drawings. 
   The hinge assembly  20  is formed by the overlapping respective articulated ends  24  and  25  with a hinge block  27  registerably positioned within the articulated free end  23  of the upper leg element  21  and a compression cap fitting  28  having a curved intermediate surface  29  is positioned over the alignment slots S in the articulated free end  24  of the lower leg element  22  in oppositely disposed aligned relation to the hinge block  27 . The compression cap  28  and hinge block  27  are registerably secured together by a pair of threaded fastener assemblies  30  extending through respective aligned apertures A therein and the corresponding slots S of the respective upper and lower leg elements  21  and  22  as hereinbefore described. 
   An effective range of motion of the upper leg element  21  to the lower leg element  22  is indicated generally in broken lines  21  and  22  in  FIG. 10  of the drawings. An example of such application of range of motion there between can be seen in  FIG. 4  of the drawings in which the lower leg element  22  has been displaced into a corresponding angular relationship with the upper leg element  22  and associated upper and lower leg engagement plates  14  and  15  secured to the patient&#39;s leg  11 . 
   It will be seen that by incremental adjustment of the hinge  20 , a variety of different angular inclinations can be achieved within the scope and range as described above. 
   Referring now to  FIGS. 2 ,  3  and  5  of the drawings, a plurality of securing straps generally indicated at  32  can be seen with the upper leg engagement plate  14  having pairs of adjustable straps  33  and  34  extending from the respective oppositely disposed strap slots  17 A and  17 B and  18 A and  18 B. Each of the strap pairs  33  and  34  has an attachment strap  35  with a buckle fitting  36  on one end and a hook and loop fabric fastener portions  37 A and  37 B on one side of the oppositely disposed end as seen in  FIG. 11  of the drawings. The straps  35  free end at  38  are looped through the respective strap slots in the upper leg engagement plate  14  and secured to itself by engagement of the hook and loop material  37 A and  37 B. 
   An extension attachment strap  39  as seen in  FIG. 12  of the drawings has oppositely disposed hook fabric surfaces  40 A and  40 B extending inwardly from one end and a loop fabric surface  40 C extending the remaining length of the strap. This arrangement of hook and loop fabric material will allow for the strap  39  to be looped through the corresponding buckle fitting  36  of the respective attachment straps  35  and extend around the patient&#39;s leg  11  and looped through oppositely disposed buckle fitting  36  of the corresponding strap  35  extending from the opposite attachment slot  17 B securing the upper leg engagement plate  14  to the patient&#39;s leg  11  as best illustrated in  FIGS. 2 and 5  of the drawings. A corresponding strap arrangement of straps  39  and  35  extend from respective slots  18 A and  18 B, the lower leg engagement plate  15  has an attachment strap  35  extending from perspective slots  17 B and  18 B and extension attachment straps  39  extending directly from respective slots  17 A and  18 A for inter-engagement about the patient&#39;s leg  11 . 
   Referring now to  FIGS. 1 and 2  of the drawings, a knee support pad  41  can be seen having a generally flat rectangular body member  42  of a soft cushion material with a reinforcement band  43  secured on the front side thereof. A pair of positioning and retaining straps  44 A and  44 B are secured across the respective upper and lower surfaces thereof. Each of the retaining straps  44 A and  44 B are made up of interconnected strips of hook  45 A and loop  45 B material as previously described and best seen in  FIG. 2  of the drawings. Corresponding knee attachment strap pairs  46 A and  46 B and  47 A and  47 B have opposing sides of hook and loop material with the end buckle fittings  46 C and  47 C respectively extend from the upper and lower leg engagement plates  14  and  15  effacing slots  17 A and  18 A and releasably engage the respective positioning and retaining straps  44 A and  44 B in end to end adjustable relation through respective buckle fittings as seen in  FIG. 1  of the drawings. 
   The knee support pad  41  as hereinbefore described provides direct support for the patient&#39;s knee  12  and is fully adjustable to accommodate and comply to the prescribed angular inclination imparted by the adjustable hinge assembly  20  as hereinbefore disclosed. 
   In use, the knee brace immobilizer  10  of the invention is positioned about a patient&#39;s leg  11  with the hinge assembly  20  being directly behind the patient&#39;s knee  12 . The flexible sheath  13  with attached upper and lower leg engagement plates  14  and  15  is wrapped around the leg  11  in overlapping relation and secured by the multiple securing straps  32  which adjustably extend from the respective leg engagement plates  14  and  15 . The adjustable hinge assembly  20  is secured to hold the leg in prescribed angular inclination by loosening and tightening of the fasteners  30  on the compression cap  28  as previously described. 
   The knee pad  41  is positioned over the knee  12  and with its retaining straps  45 A and  45 B and  46 A and  46 B are adjusted to secured the knee pad  41  in place as hereinbefore described. 
   Referring back to  FIGS. 5 and 6  of the drawings, it will be seen that each of the respective leg engagement plates  14  and  15  can be selectively adjusted in distance from the respective hinge assembly  20 &#39;s upper and lower leg elements  21  and  22  by longitudinal repositioning with the respective slots  16 A and  16 B and therefore each other through the plurality of mounting apertures A within extending in longitudinally spaced relation to one another therein. Correspondingly, the upper and lower leg engagement plates  14  and  15  have aligned plate apertures A therein which allow for selective repositioning and securing again by the fasteners F of the respective leg elements  21  and  22  therewith as indicated by adjustment areas AA in  FIG. 5  of the drawings. This will allow the leg engagement plates  14  and  15  and associated hinge assembly  20  to be used on a variety of different patients within the longitudinal adjustment parameters so describes thus making the immobilization brace  10  of the invention applicable to a variety of different in size individuals legs by simple adjustment of the overall length by the repositioning of the respective upper and lower leg elements  21  and  22  within the corresponding channels  16 A and  16 B as noted. 
   Referring now to  FIGS. 13 ,  14 ,  15  and  16  of the drawings, an alternate form of the invention can be seen in which the adjustable hinge assembly  20  has an alternate pivot fitting  51  interconnected to a modified lower leg element  52  extending from the hereinbefore described recess channels  16 B of the lower leg engagement plate  15 . 
   The pivot fitting  51  has an overlapping pivot portion  53  secured by a pivot pin  54  to a free end portion  55  of the lower leg element  52 . The pivot pin  54 , as noted, interconnects said respective overlapping pivot end portion  53  and  55  extending through centrally aligned apertures therein. An upper contoured free end  56  of the pivot fitting  51  forms part of the hinge assembly  20  by overlying a correspondingly contoured lower end  58  of the upper leg element  21  which extends from the hereinbefore described recess channels  16 A of the upper leg engagement plate  14  as set forth previously in the preferred embodiment. 
   The upper contoured free end  56  and corresponding contoured lower end  58  as described have a pair of transversely spaced longitudinally extending and overlapping and partially aligned slots S with a compression cap fitting  34 ′ thereover. Multiple fasteners F′ extend through apertures in the cap fitting  34 ′ and the respective aligned slots S into a hinge block  35 ′ with adjustable locking cap nut  57  which allows for adjustable securement of the hinge assembly  20  as hereinbefore described in the preferred embodiment set forth above. 
   Referring to  FIG. 15 , a pair of oppositely disposed limit stop fasteners  59  and  60  are threadably secured into registering threaded apertures in the pivot end portion  55  through a pair of oppositely disposed transversely spaced arcuate slot  61  and  62  in the overlapping free end portion  53  of the pivot fitting  51 . This allows pivot fitting  51  trans-lateral adjustment between the adjustable hinge assembly  20  and interconnected upper leg engagement plate  14  and the lower engagement plate  15  with incremental adjustment of the stop fasteners  39  and  60  in the respective slots  61  and  62  as indicated by broken lines in  FIG. 15  of the drawings about a central pivot point defined by the pivot pin  54 ′. Once the desired degree of lateral alignment is achieved the stop limit fasteners  59  and  60  are secured locking the so-aligned overlapping pivot engagement portion  53  to the corresponding end portion  55  of the lower leg element  52  as shown by the broken lines. 
   It will be seen that by the utilization of the pivot fitting  51  and adjustable hinge assembly  50 , a combination of both saggital plane and frontal plane brace adjustment can be achieved imparting additional utility to the knee immobilization brace of the invention. 
   It will thus be seen that a new and novel knee immobilization brace of the invention has been illustrated and described and that various changes and modifications may be made thereto without departing from the spirit of the invention.