Abstract:
A hook assembly for securing a component of an orthopaedic brace to a patient with a strap. The hook assembly includes a base for attachment to the component; and a hook member coupled to the base and including a portion normally spring-biased away from the base for accepting the strap, such that when the strap is tightened on the patient, the hook member is drawn against the base.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. patent application Ser. No. 09/863,830 filed May 23, 2001, now U.S. Pat. No. 6,740,054. This application claims priority to a provisional application filed May 23, 2000 and assigned U.S. Ser. No. 60/206,423. The disclosures of the above applications are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to orthopaedic braces. More specifically, the present invention is directed to an orthopaedic knee brace assembly and a hinge assembly therefor. 
     BACKGROUND OF THE INVENTION 
     Various devices are known for restricting the range of motion of a hinged joint to prevent injury and promote healing of a wearer&#39;s bone, joint or connective tissue. Such devices provide stabilization and support to the joint during a healing process. In addition, such devices can also be used to provide stabilization and support to an otherwise healthy joint. 
     It is often desired to limit the range of articulation of a hinged joint. For example, it is often desirable to limit the degree of extension of a knee joint during a period of rehabilitation. As the rehabilitation of the knee progresses, the knee joint typically becomes more flexible and can accommodate a greater range of extension. 
     One example of a prior known arrangement for limiting the range of articulation of a knee joint is shown and described in U.S. Pat. No. 4,715,363. This patent discloses upper and lower cuff members configured to accommodate a portion of the wearer&#39;s leg. The device is secured first with a pair of straps and subsequently with a pair of wide bands. U.S. Pat. No. 4,715,363 also discloses a set of pairs of wedges which selectively establish various maximum extension angles. The wedge pairs are secured to the hinges by threaded fasteners or screws. 
     Known devices for limiting the range of articulation of a hinged joint, including the device disclosed by U.S. Pat. No. 4,715,363, are all associated with disadvantages. For example, known devices do not allow a wearer to quickly and easily adjust a range of joint extension. Additionally, many known devices do not sufficiently and comfortably secure to a wearer&#39;s leg. 
     A need remains in the pertinent art for an improved orthopaedic brace assembly which addresses the disadvantages associated with prior known devices, including but not limited to those discussed above. 
     SUMMARY OF THE INVENTION 
     According to one aspect, the present invention relates to an orthopaedic brace assembly with improved fit and user comfort. 
     According to another aspect, the present invention relates to a hinge assembly for an orthopaedic brace which includes a plurality of removable stops for selectively adjusting a range of joint articulation. 
     In one form, the present invention provides, an orthopaedic brace assembly for constraining movement of a knee of a wearer&#39;s leg. The orthopaedic brace assembly includes a thigh cuff component, a calf cuff component and a pair of hinge assemblies. The thigh cuff component engages the wearer&#39;s leg above the knee and includes a suspension assembly having a pair of cantilevered arms. The calf cuff component engages the wearer&#39;s leg below the knee. The pair of hinge assemblies couples the thigh cuff component and the calf cuff component for relative articulation. 
     In another form, the present invention provides a hinge assembly for an orthopaedic brace including first and second arms and first and second links. The first link and second link interconnect the first and second arms for relative movement to one another through a range of articulation. The hinge assembly additionally includes a series of stops which selectively snap fit to the first arm for limiting the range of articulation. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein: 
         FIG. 1  is a front perspective view of an orthopaedic brace assembly constructed in accordance with the teachings of a preferred embodiment of the present invention, the orthopaedic brace assembly shown operatively attached to a human leg. 
         FIG. 2  is a rear perspective view of the orthopaedic brace assembly of the present invention shown removed from the leg. 
         FIG. 3  is an enlarged perspective view of the thigh cuff component of the orthopaedic brace assembly of the present invention shown operatively associated with the upper arms of a pair of hinge assemblies. 
         FIG. 4  is an enlarged perspective view of the calf cuff component of the orthopaedic brace assembly of the present invention shown operatively associated with the lower arms of a pair of hinge assemblies. 
         FIG. 5  is an enlarged perspective view of a support assembly of the orthopaedic brace assembly of the present invention. 
         FIG. 6  is an exploded perspective view illustrating the detail of Circle  6  of  FIG. 5 . 
         FIG. 7A  is an exploded perspective view illustrating the detail of Circle  7  of  FIG. 2 . 
         FIG. 7B  is a rear view of the base of  FIG. 7A . 
         FIG. 7C  is a perspective view of the hook proper of  FIG. 7A . 
         FIG. 8  is an exploded perspective view illustrating the detail of Circle  8  of  FIG. 1 . 
         FIG. 9  is a partially exploded perspective view of the hinge assembly of  FIG. 8 , illustrated to include an alternate inner link and operatively associated with a removable stop. 
         FIG. 10  is a front view of a thigh band of the orthopaedic brace assembly of the present invention. 
         FIG. 11  is a front view of a calf band of the orthopaedic brace assembly of the present invention. 
         FIG. 12  is a front view of the upper arm of the hinge assembly of  FIG. 8 . 
         FIG. 13  is a front view of the lower arm of the hinge assembly of  FIG. 8 . 
         FIG. 14  is a plan view of a mounting portion for releasable attachment to the inner link of  FIG. 9 . 
         FIG. 15  is a front view of the removable stop of  FIG. 9 . 
         FIG. 16  is a rear view of the hinge assembly of  FIG. 4  illustrated articulated to degree substantially consistent with a fully contracted knee position. 
         FIGS. 17-22  represent a series of front views of the hinge assembly of  FIG. 9 , each illustrated to include a different removable stop for establishing a maximum range of joint extension, each of the hinge assemblies articulated to the maximum extension position permitted by the particular stop. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The following description of the preferred embodiment of the present invention is merely exemplary in nature and is in no way intended to limit the subject invention or its application or uses. 
     With initial reference to  FIGS. 1 and 2 , an orthopaedic brace assembly constructed in accordance with the teachings of a preferred embodiment of the present invention is illustrated and generally identified at reference number  10 . The orthopaedic brace assembly  10  is illustrated in the exemplary embodiment as a knee brace assembly and is shown in  FIG. 1  operatively attached to a human leg  12  (shown in phantom). As shown, the knee brace assembly  10  is specifically constructed for a right leg  12 . However, it will be appreciated by those skilled in the art that the teachings of the present invention are equally applicable for a left leg and also for other hinged joints. 
     With continued reference to  FIGS. 1 and 2  and additional reference to  FIGS. 3 through 11 , the orthopaedic brace assembly  10  of the present invention will be further described. The orthopaedic brace assembly  10  is shown to generally include an upper cuff component or thigh cuff component  14 , a lower cuff component or calf cuff component  16 , a suspension assembly  17 , and a pair of hinge assemblies  18 . In the preferred embodiment, the thigh and calf cuff components  14  and  16  will be understood to be custom manufactured from a casting taken from a specific patient. 
     The thigh cuff component  14  is formed to fit the anterior portion of the wearer&#39;s leg above the knee. The thigh cuff component  14  includes two downwardly extending portions  20  and  24  positioned medially and laterally relative to the wearer&#39;s knee, respectively. A femoral transverse portion  26  of the thigh cuff component  14  is arcuately curved to conform to the wearer&#39;s thigh and includes a first end which intersects the downwardly extending portion  20  at an upper medial corner  28 . The transverse member  26  transitions downwardly at an angle as it anteriorly circumscribes the wearer&#39;s thigh and intersects the downwardly extending portion  24 . The thigh cuff component  14  is open at the posterior so that it may be placed over the user&#39;s leg  12  from the front. 
     With particular reference to  FIGS. 1 ,  5  and  6 , the thigh cuff component  14  is shown operatively associated with a suspension assembly  17 . The suspension assembly  17  includes a pair of cantilevered suspension arms  30  and  32 . The arms  30  and  32  engage the wearer&#39;s leg  12  above the knee. More specifically, the suspension arms  30  and  32  are positioned to engage the wearer&#39;s leg  12  superior to the condyles of the femur. In full knee flexion, the suspension arms  30  and  32  operate to control the tibia by providing translational and rotational stability otherwise provided by a normally functioning anterior cruciate ligament. The suspension arms  30  and  32  also function to prevent the brace assembly  10  from migrating during knee articulation. Each of the arms  30  and  32  is attached to one of the downwardly extending portions  20  and  24  through an angled bracket  34  (shown particularly in  FIGS. 5 and 6 ). The angled brackets  34  inwardly orientate the arms  30  and  32  relative to the wearer&#39;s leg  12  at an angle of approximately 30°. In one particular application, each of the angled brackets  34  is secured to an associated one of the downwardly extending portions  20  and  24  with a pair of screws (not shown). Alternatively, the angled brackets  34  can be welded or otherwise fixedly attached. 
     Each of the arms  30  and  32  include a hemispherical cushioning member or dome member  36  attached to an inner side for directly engaging the wearer&#39;s leg  12 . In the preferred embodiment, the cushioning members  36  are formed to include a stem  35  which is received by a base  37  and adhesively banded to the base  37 . The base  37  is press-fit into an aperture  39  provided in the end of the associated angled bracket  34 . 
     In the preferred embodiment, the arms  30  and  32  of the suspension assembly  17  are connected by a strap  38 . The strap  38  is attached to each of the angled brackets  34  through capture between the angled bracket  34  and an injection molded suspension body  40 . The suspension body  40  is secured to the associated angled bracket  34  through a rivet  42 . An inwardly extending portion  41  of the bases  37  includes a reduced diameter portion  43  to accommodate the strap  38 . 
     With particular reference to  FIGS. 1 and 4 , the calf cuff component  16  is constructed to include a calf transverse portion  44  which circumscribes the anterior portion of the wearer&#39;s leg  12  below the knee. The calf cuff component  16  is shown to further include a lower stabilizing portion or proprioceptive arm  46  connected to the tibial transverse portion  44  through an intermediate segment or keel  48 . The keel  48  is positioned to be located on the medial side of the tibia. A center of the transverse portion  44  includes a shallow channel  39  to provide additional clearance from the crest of the tibia. In this manner, a more aggressive purchase of the tibia can be comfortably made so as to better control the tibia. As with the thigh cuff component  14 , the calf cuff component  16  is open at the posterior so that it may be placed over the user&#39;s leg  12  from the front. 
     The angled brackets  34  are preferably constructed of thin steel or other suitable material. For point of reference, the stem of each of the cushioning members  36  define an axis. The angled brackets  34  are configured to permit movement of the associated cushioning member  36  along this axis during flexion and extension of the knee. This movement in cooperation with the elastic strap  38  functions to maintain a clamping force against the wearer&#39;s leg  12  in an area above the knee to a comfortable yet effective degree and thereby prevent migration of the brace assembly  10 . 
     Both the thigh and calf cuff components  14  and  16  are made of a lightweight, thermoset or thermoplastic material which can be formed to fit the contours of an individual wearer&#39;s leg. One suitable material for forming the cuff components  14  and  16  is a carbon fiber, preimpregnated material with a core material such as balsa wood or an expanding foam adhesive. However, those skilled in the art will readily appreciate that other materials may be employed. 
     The thigh cuff component  14  and the calf cuff component  16  are padded on the inside by padded bands  50  and  52  which are elastically stretchable and wrap around the wearer&#39;s leg both above and below the knee. The padded bands  50  and  52  are suitably secured to the femoral and calf components  14  and  16 , respectively, and each include a hooked material portion  53  for attachment anywhere along the respective band  50  or  52 . The padded band  50  for the thigh component  14  is shown most particularly in  FIG. 10  and is configured to provide a protective barrier between the wearer&#39;s leg  12  and the each of the downwardly extending portions  20  and  24  and the transverse member  26 . The padded band  50  is further configured to wrap around the wearer&#39;s thigh. 
     The padded band  52  is similarly configured to provide a protective barrier between the wearer&#39;s leg  12  and the transverse portion  44 , the preprioceptive arm  46  and the keel  48  and to also wrap around the wearer&#39;s calf. In the embodiment illustrated, the padded band  52  includes an upper radiused portion  55  or preprioceptive portion  55  that surrounds an anterior portion of the superior calf. The padded bands  50  and  52  may be secured to the associated one of the thigh and calf components  14  and  16  with looped material, with fasteners, or in any other known manner. 
     The brace assembly  10  may be further secured to the wearer&#39;s leg  12  through a pair of non-elastic straps  56  (shown in  FIG. 1 ). In the preferred embodiment, the straps  56  are secured to the assembly  10  through a plurality of hook assemblies  58 . One of the hook assemblies  58  will be described with particular reference to  FIGS. 7A through 7C . The hook assemblies  58  are shown to include a cap member or base  55  that is received within one of a plurality of countersunk portions  57  of the thigh and calf components  14  and  16 . A rear surface of the base  55  includes an internally threaded boss portion  59 . The boss portion  59  receives a threaded fastener  61  which passes through a washer and an aperture (not particularly shown) in the associated one of the thigh and calf components  14  and  16 . The base  55  includes a pair of cut-out portions  63  which preferably taper in a radially inward direction. The cut-out portions  63  receive free ends of a wire form or hook proper  65 . 
     The hook proper  65  is configured such that when the hook assembly  58  is secured to the assembly  10 , the hook proper  65  outwardly extends due to an inherent spring bias. As such, the hook propers  65  are more easily engaged by the straps  56 . Upon tightening, the straps  56  draw the hook propers  65  against the associate base  55 . 
     In the embodiment illustrated, a lower one of the straps  56  starts at the hook assembly  58  of a medial distal end of the preprioceptive arm  46 , passes through the hook assembly  58  positioned at the lateral proximal side of the transverse portion  44  and terminates at the hook assembly  58  located at the medial proximal side of the transverse portion  44 . An upper one of the straps  56  starts at the hook assembly  58  positioned at the corner  28 , passes through the hook assembly  58  positioned on medial proximal one of the downwardly extending portions  20  and terminates at the hook assembly  58  positioned on the lateral distal one of the hook assembly  58  positioned on the medial one of the downwardly extending portions  24 . Preferably, the straps  56  secure to themselves through hook and loop material portions (not shown). 
     A medial one of the hinge assemblies  18  of the orthopaedic brace assembly  10  of the present invention is shown in further detail in the exploded view of  FIG. 8 . It will be understood that the lateral one of the hinge assemblies  18  is a substantial mirror image thereof. The hinge assemblies  18  provide for an articulating connection between the thigh component  14  and the calf component  16 . 
     The hinge assembly  18  is preferably illustrated as a four bar linkage hinge assembly with polycentric motion and is shown to generally include a first or upper arm  60 , a second or lower arm  62 , a first or outer link  64  and a second or inner link  66 . In one application, the upper arm  60 , the lower arm  62 , the outer link  64 , and the inner link  66  are each constructed of a lightweight material such as aluminum, stainless steel, titanium, or other suitable material. However, those skilled in the art will appreciate that alternate materials having suitable strength requirements may be readily substituted in the teachings of the present invention. 
     The upper arm  60  includes an upper end  68  which is secured to the downwardly extending portion  24 . A lower end  70  of the upper arm  60  is secured to both the outer link  64  and the inner link  66  for relative pivotal motion. A first pin  72  defines a pivot axis between the upper arm  60  and the outer link  64 . A second pin  74  defines a pivot axis between the upper arm  60  and the inner link  66 . 
     The lower arm  62  is similarly constructed to include a lower end  76  attached to the calf cuff component  16  and an upper end  78  pivotally connected to both the inner and outer links  66  and  64 . A first pivot pin  80  pivotally interconnects the lower arm  62  and the outer link  64  and a second pivot pin  82  pivotally interconnects the tibial arm  76  and the inner link  66 . In the application illustrated, the first pin  80  defines the pivot axis between the tibial arm  76  and the outer link  64  and is fixedly carried by the outer link  64  and rotatably attached to the lower arm  62 . The second pivot pin  82  defines the pivot axis between the lower arm  62  and the inner link  66  and is fixedly carried by the inner link  66  and pivotally interconnected to the lower arm  62 . 
     The hinge assemblies  18  include a condyle pad  86  for placement adjacent the wearer&#39;s leg  12 . The condyle pads  86  serve as protective members against impacts in the lateral and medial directions of the wearer&#39;s leg  12 . One of the condyle pads  86  is shown most particularly in  FIG. 8 . 
     In the embodiment of  FIG. 8 , the condyle pads  86  are shown to include a cushioning portion  88  and a mounting portion  90 . In one application, the cushioning portion  88  carries a hook material for releasable attachment to a looped material carried by the mounting portion  90 . The mounting portion  90  is captured between the outer link  66  and the upper and lower arms  60  and  62 . 
     In the embodiment of  FIG. 9 , an alternate inner link  66 ′ is shown which cooperates with an alternate mounting portion  90 ′ (shown most particularly in  FIG. 14 ). With this arrangement, the mounting portion  90 ′ is adapted to be quickly and easily secured to the remainder of the hinge assembly  18 . In the embodiment illustrated, the mounting portion  90 ′ is again secured to the inner link  66 ′ of the hinge assembly  18 . In this manner, the condyle pad  86  moves with the inner link  66  throughout the range of articulation of the wearer&#39;s knee. 
     As shown in  FIG. 14 , an outer facing side  92  of the mounting member  90  is formed to include a circular boss  94  to which a retaining element  96  is fixedly secured by a rivet  98 . The retaining element  96  is shown to have a generally bow-tie shape. The element  96  is received in a similarly shaped recess  100  (shown particularly in  FIG. 9 ) defined in a inner facing side  102  of the inner link  66 . Upon insertion, opposing ends  102  and  104  of the element  96  are positioned against flanges  106  and  108 , respectively. The mounting member  90 ′ is then rotated clockwise (as shown in  FIG. 9 ) approximately 30 to 35 degrees such that the ends  102  and  104  are positioned below a pair of flanges  110  and  112 , respectively. 
     With additional reference to  FIGS. 15-22 , both of the hinge assemblies  18  of the present invention is shown to include a series of stops  120 A- 120 F for selectively limiting the range of articulation of the wearer&#39;s knee. In the embodiment illustrated, the stops  120 A- 120 F are employed to limit the degree of extension of the wearer&#39;s knee. Alternatively, the stops may be configured to selectively limit flexion of the knee or both extension and flexion. 
       FIGS. 15-22  illustrate the stops  120 A- 120 F operatively associated with the hinge assembly  18  to include the alternate inner link  66 ′ of  FIG. 9 . The stops  120 A- 120 F will be understood to be identically employed with the inner link  66  of the arrangement shown in  FIG. 8 . 
     A first stop  120 A of the series of stops is shown in  FIGS. 15-17 . The first stop  120 A is intended to limit extension of the wearer&#39;s knee to −10° from longitudinal axially alignment of the wearer&#39;s femur and tibia as viewed from a medial or lateral side. In particular and in accordance with the preferred embodiment of the present invention, the series of stops is shown to include five additional stops  120 B,  120 C,  120 D,  120 E, and  120 F for establishing maximum extension angles of 0°, 10°, 20°, 30°, 40°, respectively (from longitudinal axial alignment of the tibia and femur). Each of the stops  120 A- 120 F is configured to quickly and easily engaged the remainder of the hinge assembly  18  without the need for discrete tools. In one application, the stops  120 A- 120 F are each injection molded of a resilient plastic or glass reinforced nylon. 
     The first stop  120 A is illustrated particularly in  FIG. 15  to define a partial cylindrical opening  122 . The opening  122  corresponds in size and shape to a generally cylindrical extension  124  carried at the lower end  70  of the upper arm  60 . The circular opening  122  preferably defines slightly more than half of a circle. Due to the resilient nature of the stop  120 A, the circular opening  122  snapingly engages the circular extension  124 . A first end  126  of the stop  120 A abuts one of the vertical sides  128  of the upper arm  60  and a second end  129  abuts a lower side  130  of the femoral arm. In this manner, rotation of the stop  120 A relative to the upper arm  60  is prevented upon the snapping engagement. The stop  120  is also captured in a medial lateral direction between the inner link  66 ′ and the outer link  64 . 
     The stop  120 A is configured to include a lower stop surface  132  configured to matingly abut an upper side  134  of the lower arm  62 . Specifically, the lower stop surface  132  engages the upper side  134  at the point of desired maximum extension of the wearer&#39;s knee. For the first stop  120 A, this point of maximum desired extension is −10°. As shown particularly in  FIG. 16 , the series of stops of the present invention will not limit articulation of the hinge assembly  18  in flexion. 
     The remaining stops  120 B- 120 F are shown in  FIGS. 18-22  operatively associated with the remainder of the hinge assembly  18 . It will be understood that these remaining stops  120 B- 120 F are substantially identical to the first stop  120 A with the exception that the lower stop surface  132  is configured and positioned relative to the circular opening  122  so as to engage the upper surface  134  of the lower arm  62  at the desired maximum angle of extension. 
     While the invention has been described in the specification and illustrated in the drawings with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention as defined in the claims. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment illustrated by the drawings and described in the specification as the best mode presently contemplated for carrying out this invention, but that the invention will include any embodiments falling within the description of the appended claims. For example, various aspects of the teachings of the present invention are applicable for bracing other hinged joints, such as an elbow.