Patent Document

BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The present invention relates to orthopedic braces. More particularly, the present application describes a hinge for an orthopedic brace having a condyle pad that is adjustable toward and away from a joint.  
           [0003]    2. Description of the Related Art  
           [0004]    Orthopedic knee braces are typically worn either to support a healthy knee joint and prevent injury, or to stabilize a knee joint that has been destabilized by an injury or other condition. These braces generally include rigid structural components that support or stabilize the knee joint. The rigid structural components are dynamically linked together by one or more hinges that enable controlled pivotal movement of the knee joint during user activity or rehabilitative therapy. The brace is positioned on the leg such that the hinges traverse the knee joint, while the rigid components are secured to the leg above and below the knee joint.  
           [0005]    Osteoarthritis is a degenerative disease that destabilizes the knee joint. The disease commonly results from aging, knee joint overuse, or injury. A person afflicted with osteoarthritis suffers chronic pain when his or her knee joint is statically or dynamically loaded. The pain is caused by an unbalanced loading on the knee joint. The unbalanced loading often closes a compartment between the condyles of the femur and tibia. When these condyles contact one another, their contacting surfaces develop painful abrasions.  
           [0006]    Wearing an orthopedic knee brace on the affected leg is one common noninvasive method of treating osteoarthritis pain. These braces apply a force to a medial or lateral side of the knee in order to unload the affected compartment of the knee joint and eliminate contact between the femur and tibia. U.S. Pat. No. 5,277,698 discloses an example of such a brace. This brace applies a force to the knee on that side of the knee remote from the compartment having osteoarthritis as the knee moves to extension. Preferably, the force is applied at a point about 10° to 15° posterior of the normal axis of rotation of the knee.  
           [0007]    U.S. Pat. No. 5,586,970 discloses a knee brace having a medial condylar pad 34 and a lateral condylar pad 36 that are each independently adjustable in side-to-side motion. This independent adjustment permits either medial condylar pad 34 or lateral condylar pad 36 to have variable pressure with respect to a user&#39;s knee 26.  
           [0008]    U.S. Pat. No. 5,807,294 discloses a hinge assembly 14 for an orthopedic knee brace 10 that pivotally couples an upper arm 34 and a lower arm 46. The hinge assembly includes a pad assembly 24, 26, a hinge 22, and upper and lower adjustment members 74, 88 enabling adjustment of the normal force applied by the hinge assembly to the knee joint for the treatment of osteoarthritis. The hinge includes an end of the upper arm, an end of the lower arm, outer and inner hinge plates 58, 60 positioned on opposite sides of the ends, and upper and lower hinge fasteners 68, 82. The upper and lower hinge fasteners each have a bore therethrough that is internally threaded. The upper hinge fastener rotatably connects the end of the upper arm to the outer and inner hinge plates and the lower hinge fastener rotatably connects the end of the lower arm to the outer and inner hinge plates. The upper adjustment member has external threads that are received by the internal threads of the upper hinge fastener to telescopically couple the upper adjustment member to the upper hinge fastener. The lower adjustment member likewise has external threads that are received by the internal threads of the lower hinge fastener to telescopically couple the lower adjustment member to the lower hinge fastener. Both the upper and lower adjustment members have ends that are substantially fixedly coupled to the pad holder. As a result, the pad assembly is selectively displaceable toward or away from the hinge when the user selectively displaces the upper and lower adjustment members through the upper and lower bores of the upper and lower hinge fasteners.  
           [0009]    No current brace allows a wearer to provide greater pressure on an anterior portion of his or her knee as compared to a posterior portion. Such a brace would be advantageous for both treating and preventing certain types of injuries.  
         SUMMARY OF THE INVENTION  
         [0010]    The preferred embodiments of the brace hinge with telescoping condyle pad have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of this brace hinge with telescoping condyle pad as expressed by the claims that follow, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description of the Preferred Embodiments,” one will understand how the features of the preferred embodiments provide advantages, which include the capability to apply greater pressure to an anterior portion of a joint than to a posterior portion of the joint, and vice versa.  
           [0011]    A preferred embodiment of the brace hinge comprises a first hinge plate including an anterior aperture and a posterior aperture. A lateral/medial force application assembly is attached to the first hinge plate by an anterior adjustment member and a posterior adjustment member. The adjustment members are connected at a medial end of each to the force application assembly, and the anterior adjustment member telescopingly engages the anterior aperture and the posterior adjustment member telescopingly engages the posterior aperture, such that manipulation of the adjustment members enables adjustment of a distance between the first hinge plate and the force application assembly.  
           [0012]    Another preferred embodiment comprises a method of treating a knee. The method comprises the steps of applying a brace to a leg including the knee, and applying pressure to a medial or lateral side of the knee. The pressure is applied to the knee such that an anterior portion of the knee is under greater pressure than a posterior portion of the knee, or vice versa. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]    The preferred embodiments of the brace hinge with telescoping condyle pad, illustrating its features, will now be discussed in detail. These embodiments depict the novel and non-obvious brace hinge with telescoping condyle pad shown in the accompanying drawings, which are for illustrative purposes only. These drawings include the following figures, in which like numerals indicate like parts:  
         [0014]    [0014]FIG. 1 is a perspective view of a preferred embodiment of the hinge with telescoping condyle pad according to the present invention;  
         [0015]    [0015]FIG. 2 is an exploded perspective view of the hinge of FIG. 1;  
         [0016]    [0016]FIG. 3 is a front elevation view of the hinge of FIG. 1;  
         [0017]    [0017]FIG. 4 is a right-side elevation view of the hinge of FIG. 1;  
         [0018]    [0018]FIG. 5 is a right-side section view of the hinge of FIG. 1 taken along the line  5 - 5  of FIG. 3;  
         [0019]    [0019]FIG. 6 is a perspective view of a loading screw of the hinge of FIG. 1;  
         [0020]    [0020]FIG. 7A is a top section view of the hinge of FIG. 1 taken along the line  7 - 7  of FIG. 4, illustrating the medial/lateral force application assembly at a minimum extension from the hinge;  
         [0021]    [0021]FIG. 7B is a top section view of the hinge of FIG. 1 taken along the line  7 - 7  of FIG. 4, illustrating the medial/lateral force application assembly at a maximum extension from the hinge; and  
         [0022]    [0022]FIG. 7C is a top section view of the hinge of FIG. 1 taken along the line  7 - 7  of FIG. 4, illustrating the medial/lateral force application assembly in an orientation for applying greater force to a posterior portion than to an anterior portion of a wearer&#39;s knee. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0023]    [0023]FIG. 1 illustrates a preferred embodiment of the brace hinge with telescoping condyle pad. The hinge  20  is preferably a component of a knee brace (not shown) that is designed to treat osteoarthritis. Those of skill in the art will appreciate, however, that the hinge  20  is adapted for use in a variety of braces, including prophylactic knee braces worn about healthy knees, and braces for parts of the body other than the knee. For simplicity, the construction and function of the hinge  20  will be described with reference to a knee brace.  
         [0024]    The illustrated hinge  20  is adapted for use on a lateral side of a right leg, or a medial side of a left leg. Those of skill in the art will appreciate that a substantially identical hinge having a mirror image configuration would be adapted for use on a medial side of a right leg, or a lateral side of a left leg. For simplicity, the present hinge  20  will be described with reference to a lateral side of a right leg. The scope of the present hinge  20  is not, however, limited to an application to a lateral side of a right leg.  
         [0025]    The hinge  20  comprises a proximal arm  22  and a distal arm  24  pivotably engaging a hinge assembly. The hinge assembly comprises a lateral hinge plate  26  and a medial hinge plate  28 , as shown in the exploded view of FIG. 2. Each of the hinge plates  26 ,  28  is substantially oval in front elevation aspect (FIG. 3), and each includes a proximal aperture  30  and a distal aperture  32  (FIG. 2). The proximal aperture  30  is located substantially in the center of a proximal half of each hinge plate  26 ,  28 , and the distal aperture  32  is located substantially in the center of a distal half of each hinge plate  26 ,  28 .  
         [0026]    Each of the hinge plates  26 ,  28  also includes an anterior aperture  34  and a posterior aperture  36 . Each anterior aperture  34  is located near a center of an anterior edge  38  of its respective plate, and each posterior aperture  36  is located near a center of a posterior edge  40  of its respective plate. Those of skill in the art will appreciate that the apertures  34 ,  36  need not be arranged in the fashion illustrated. Both could for example, be located toward one side of the hinge plates, or be spaced from a proximal/distal axis of the hinge plates. The anterior and posterior apertures  34 ,  36  include internal threads that cooperate with an anterior loading screw  44  and a posterior loading screw  46 , respectively, to adjust an amount of pressure exerted on a lateral side of the wearer&#39;s knee, as explained below.  
         [0027]    The proximal arm  22  is a substantially flat plate having a hinge-engaging portion  48  at a distal end, and an upright-engaging portion  50  at a proximal end. The upright-engaging portion  50  is substantially rectangular, while the hinge-engaging portion  48  has a complex perimeter, including an anterior shoulder  52 , a posterior shoulder  54 , and a plurality of gear teeth  56  along proximal and posterior edges. The proximal arm  22  includes a pivot aperture  58  near the distal end. The distal arm  24  is substantially identical to the proximal arm  22 , but is a substantial mirror image of the proximal arm  22  about a line that passes through a center of the hinge  20  in an anterior/posterior direction.  
         [0028]    In a knee brace, the proximal arm  22  preferably engages a rigid proximal upright (not shown), and the distal arm  24  preferably engages a rigid distal upright (not shown). The proximal and distal uprights are secured to the wearer&#39;s thigh and calf, respectively, with straps, cuffs or other suitable attachment devices. The uprights and their attachment devices thus anchor the brace to the wearer&#39;s leg and enable the brace to provide the advantages outlined below.  
         [0029]    The proximal and distal arms  22 ,  24  are sandwiched between the lateral and distal hinge plates  26 ,  28  such that the pivot aperture  58  on the proximal arm  22  is coaxial with the proximal apertures  30  of the hinge plates  26 ,  28 , and the pivot aperture on the distal arm  24  is coaxial with the distal apertures  32  of the hinge plates  26 ,  28 . The arms  22 ,  24  are preferably attached to the hinge plates  26 ,  28  with rivets or other suitable attachment members that allow the arms to pivot with respect to the hinge plates  26 ,  28 . In the embodiment of FIG. 5, a pair of lateral rivets  60  pass through the proximal and distal apertures  30 ,  32  of the lateral hinge plate  26 , through the pivot apertures of the proximal and distal arms  22 ,  24 , and through the proximal and distal apertures  30 ,  32  of the medial hinge plate  28 . Those of skill in the art will appreciate that other attachment devices and methods could be used instead of the attachment configuration shown.  
         [0030]    An optional extension stop  62  (FIG. 2) is mounted to a lateral face  64  of the medial hinge plate  28  near a center of the anterior edge  38 . The anterior shoulder  52  of each arm  22 ,  24  cooperates with the extension stop  62  to define a maximum extension angle for each arm  22 ,  24 . An optional flexion stop (not shown) is securable to the medial hinge plate  28  near a center of the posterior edge  40 . The posterior shoulder  54  of each arm cooperates with the flexion stop to define a maximum flexion angle for each arm  22 ,  24 .  
         [0031]    In the illustrated embodiment, the extension stop  62  includes proximal and distal apertures  66 ,  68  that align with corresponding apertures  70 ,  72  adjacent the anterior edge  38  of the medial hinge plate  28 . The extension stop  62  is secured to the medial hinge plate  28  with threaded fasteners, rivets, or other suitable attachment members that cooperate with the apertures  66 ,  68 ,  70 ,  72 . The optional flexion stop, if one is provided, is secured to the medial hinge plate  28  in a similar fashion. Those of skill in the art will appreciate that the stops could be secured to the hinge plates  26 ,  28  in a variety of alternate ways, such as with an adhesive. Those of skill in the art will further appreciate that neither the extension stop  62  nor the flexion stop is essential to achieving the advantages of the hinge  20 .  
         [0032]    As illustrated in FIG. 2, an axis of rotation  74  of the proximal arm  22  is parallel to, but spaced from, an axis of rotation  76  of the distal arm  24 . Such a bicentric hinge assembly more closely approximates the bending dynamics of the human knee, as is well understood in the art of orthopedic bracing. Those of skill in the art will appreciate, however, that the features and advantages of the present hinge  20  may also be achieved with a monocentric hinge.  
         [0033]    Preferably, a lateral spacer  78  separates the lateral hinge plate  26  from the arms  22 ,  24 , and a medial spacer  80  separates the medial hinge plate  28  from the arms  22 ,  24 . Each of the spacers  78 ,  80  is shaped substantially the same as the hinge plates  26 ,  28 , including a substantially oval-shaped perimeter and proximal and distal apertures  82 ,  84 . The spacers  78 ,  80  are oriented such that their proximal and distal apertures  82 ,  84  align with the proximal and distal apertures  30 ,  32 , respectively, of the hinge plates  26 ,  28 . The spacers  78 ,  80  are preferably constructed of a material having a low coefficient of friction, such as a plastic. The spacers  78 ,  80  thus enable the arms  22 ,  24  to rotate more easily within the hinge assembly. Those of skill in the art will appreciate that the spacers  78 ,  80  could be shaped much differently, or could be eliminated entirely, without departing from the spirit of the hinge  20 .  
         [0034]    A lateral/medial force application assembly  86  telescopingly engages the hinge assembly on a medial side, as shown in FIGS. 4, 5 and  7 A- 7 C. The assembly comprises a rigid loading plate  88  and a substantially rigid condyle shell  90 . For comfort, a resilient pad (not shown) may be attached to a medial surface of the shell  90 . Either the shell  90  or the optional pad applies selective pressure to the lateral side of the wearer&#39;s right knee in a manner described below.  
         [0035]    The loading plate  88  is substantially oval shaped and includes a proximal aperture  92  (FIGS. 2 and 7A) and a distal aperture  94  corresponding to the proximal and distal apertures  30 ,  32 , respectively, of the hinge plates  26 ,  28 . The condyle shell  90  is also substantially oval shaped and includes proximal and distal apertures  96 ,  98  (FIGS. 2 and 5) corresponding to the proximal and distal apertures  30 ,  32 , respectively, of the loading plate  88 . A medial surface  100  of the loading plate  88  is secured to a lateral surface  102  of the condyle shell  90 , as shown in FIG. 5. In the illustrated embodiment, the loading plate  88  is secured to the condyle shell  90  via a pair of medial rivets  104  that cooperate with the proximal and distal apertures  92 ,  94 ,  96 ,  98  on the loading plate  88  and condyle shell  90 . Those of skill in the art will appreciate that the loading plate  88  and the condyle shell  90  could be secured to one another by other appropriate methods, such as by an adhesive.  
         [0036]    Adjustment of the loading plate  88  and condyle shell  90  provides selective pressure on the wearer&#39;s knee, as described below. Thus, the loading plate  88  is preferably constructed of a rigid material such as a metal. In the illustrated embodiment, anterior and posterior edges  106 ,  108  (FIGS. 2 and 7A) of the loading plate  88  are bent away from a plane of the plate  88  in a lateral direction. The bent edges  106 ,  108  increase the bending strength of the plate  88 , enhancing the ability of the plate  88  to apply pressure to the wearer&#39;s knee. Those of skill in the art will appreciate that the bent edges  106 ,  108  are not necessary to achieve the advantages of the hinge  20 .  
         [0037]    The loading plate  88  includes an anterior slot  110  (FIGS. 2 and 7A) running in an anterior/posterior direction. The anterior slot  110  is located near a center of the loading plate  88  as measured in a proximal/distal direction. The anterior slot  110  includes a wide portion at a posterior end  114 , and a narrow portion at an anterior end  116 . The loading plate  88  also includes a posterior slot  112  that is substantially identical to the anterior slot  110 , but is a mirror image of the anterior slot  110  about a line bisecting the loading plate  88  in a proximal/distal direction.  
         [0038]    The anterior slot  110  receives a medial end  118  of an anterior loading screw  44 , illustrated in FIGS. 6 and 7B. The posterior slot  112  receives a medial end  118  of a posterior loading screw  46 . The anterior and posterior loading screws  44 ,  46  are substantially identical. As FIG. 6 illustrates, the screws  44 ,  46  include a threaded lateral portion  120  having a drive tool engagement feature, such as a female hex key  122 , on a lateral face  124 . The threaded portion  120  terminates near a medial end of the screw  44 ,  46  in a first coaxial disk  126  having a diameter larger than that of the threaded portion  120 . A second coaxial disk  128  is attached to the first disk  126  via a coaxial cylindrical portion  130  having a diameter substantially the same as the threaded portion  120 . A space between the two disks  126 ,  128  thus defines an annular gap  132 .  
         [0039]    The gap  132  on the anterior loading screw  44  engages the anterior slot  110  on the loading plate  88 , and the gap  132  on the posterior loading screw  46  engages the posterior slot  112  on the loading plate  88 , as shown in FIG. 7B. The disks  126 ,  128  at the medial ends  118  of the screws  44 ,  46  each have a smaller diameter than a width of the wide portions of the anterior and posterior slots  110 ,  112 . However, the disks  126 ,  128  each have a larger diameter than a width of the narrow portions of the anterior and posterior slots  110 ,  112 . Further, the cylindrical portions  130  of each screw  44 ,  46  between the disks  126 ,  128  have a smaller diameter than the width of the narrow portions of the anterior and posterior slots  110 ,  112 . Thus, the anterior loading screw  44  is insertable within the wide portion of the anterior slot  110  and slidable into the narrow portion of the anterior slot  110  such that the sides of the narrow portion of the anterior slot  110  are disposed between the disks  126 ,  128 . The anterior slot  110  thus fixes the anterior loading screw  44  against translation in a direction perpendicular to the loading plate  88 . The slot sides are, however, somewhat thinner than the distance between the disks  126 ,  128 , such that there is a small amount of “play” between the loading plate  88  and the screws  44 ,  46 , as shown in FIG. 7B. The posterior loading screw  46  is engageable with the posterior slot  112  in the same manner that the anterior loading screw  44  is engageable with the anterior slot  110 .  
         [0040]    The threaded portion  120  of the anterior loading screw  44  engages the anterior holes  34  in the hinge plates  26 ,  28 , as shown in FIG. 7C. The threaded portion  120  of the posterior loading screw  46  engages the posterior holes  36  in the hinge plates  26 ,  28 . Thus, the screws  44 ,  46  are selectively positionable with respect to the hinge plates  26 ,  28  in a direction perpendicular to the hinge plates  26 ,  28 . Because the screws  44 ,  46  are fixed to the loading plate  88 , adjusting the position of the screws  44 ,  46  within the apertures also adjusts the position and orientation of the loading plate  88  and condyle shell  90  with respect to the hinge plates  26 ,  28 .  
         [0041]    [0041]FIG. 7A illustrates the loading screws  44 ,  46  adjusted such that both screws  44 ,  46  extend a minimum distance in the medial direction from the hinge plates  26 ,  28 . In this configuration, the loading plate  88  and condyle shell  90  are substantially parallel to the hinge plates  26 ,  28  and spaced only slightly from the hinge plates  26 ,  28 . The condyle shell  90  (or optional pad) thus applies little or no pressure to the wearer&#39;s knee, and any pressure is applied evenly across the knee in an anterior/posterior direction.  
         [0042]    [0042]FIG. 7B illustrates the loading screws  44 ,  46  adjusted such that both screws  44 ,  46  extend a maximum distance in the medial direction from the hinge plates  26 ,  28 . In this configuration, the loading plate  88  and condyle shell  90  are substantially parallel to the hinge plates  26 ,  28  and spaced greatly from the hinge plates  26 ,  28 . The condyle shell  90  (or optional pad) thus applies maximum pressure to the wearer&#39;s knee, and the pressure is applied evenly across the knee in an anterior/posterior direction.  
         [0043]    [0043]FIG. 7C illustrates the loading screws  44 ,  46  adjusted such that the posterior loading screw  46  extends from the hinge plates  26 ,  28  in the medial direction a greater amount than the anterior loading screw  44 . In this configuration, the loading plate  88  and condyle shell  90  are oriented at an angle relative to the hinge plates  26 ,  28 . The condyle shell  90  (or optional pad) thus applies greater pressure to a posterior portion of the wearer&#39;s knee than to an anterior portion of the wearer&#39;s knee.  
         [0044]    Although not depicted, the lateral/medial force application assembly  86  is also configurable in a manner opposite from that of FIG. 7C. In this configuration the anterior loading screw  44  extends from the hinge plates  26 ,  28  in the medial direction a greater amount than the posterior loading screw  46 . The condyle shell  90  (or optional pad) thus applies greater pressure to an anterior portion of the wearer&#39;s knee than to a posterior portion of the wearer&#39;s knee.  
         [0045]    The ability of a brace including the present hinge  20  to apply differing pressures to anterior and posterior portions of a wearer&#39;s knee enables such a brace to be adapted to a wide variety of treatment situations. Every human knee is unique, and there are a wide variety of knee injuries and knee injury prevention situations. In certain situations it is advantageous for a patient to have greater pressure applied to an anterior portion of his or her knee, and in certain other situations it is advantageous for a patient to have greater pressure applied to a posterior portion of his or her knee. Current braces do not allow for such adjustable application of pressure to anterior and posterior portions of a patient&#39;s knee as does a brace including the present hinge  20 .  
         [0046]    Further, the configuration of the present hinge  20  spread loads over a greater area of the hinge plates  26 ,  28  than other current designs. For example, in the hinge of U.S. Pat. No. 5,807,294, described above, the adjustment members  74 ,  88  pass through the hinge fasteners  68 ,  82 . Thus, all loads applied to the lateral pad  26  are transmitted to the hinge fasteners, and all loads applied to the arms  34 ,  46  are also transmitted to the hinge fasteners. The hinge fasteners in turn transmit these loads to the areas of the hinge plates  58 ,  60  in which they are disposed. This configuration concentrates tremendous loads on two small areas of the hinge plates  58 ,  60 . These loads lead to rapid wear of the hinge plates  58 ,  60  and eventually failure.  
         [0047]    In the configuration of the present hinge  20 , however, loads applied to the condyle shell  90  are transmitted through the loading screws  44 ,  46  to the anterior and posterior aperture  34 ,  36  of the hinge plates  26 ,  28 . Loads applied to the arms  22 ,  24  are transmitted through the lateral rivets  60  to the proximal and distal aperture  30 ,  32  of the hinge plates  26 ,  28 . The loads are thus spread over a greater area of the hinge plates  26 ,  28 . The hinge plates  26 ,  28  are thus able to withstand more prolonged use without failure. Alternatively, the hinge plates  26 ,  28  are able to be made using less material, which results in lighter hinge plates and an overall lighter brace.  
       SCOPE OF THE INVENTION  
       [0048]    The above presents a description of the best mode contemplated for the present brace hinge with telescoping condyle pad, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this brace hinge with telescoping condyle pad. This brace hinge with telescoping condyle pad is, however, susceptible to modifications and alternate constructions from that discussed above which are fully equivalent. Consequently, it is not the intention to limit this brace hinge with telescoping condyle pad to the particular embodiments disclosed. On the contrary, the intention is to cover all modifications and alternate constructions coming within the spirit and scope of the brace hinge with telescoping condyle pad as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the brace hinge with telescoping condyle pad.

Technology Category: 1