Abstract:
A brace for supporting the knee of the wearer. The brace has an adjustable support mechanism for accommodating a variety of leg shapes. The hinge portion of the brace is adjustable so that there is proper balanced support on opposite sides of the knee. Furthermore, the brace is universal in applicability and may be used on either the right or left leg.

Description:
CROSS-REFERENCE 
   This application claims priority from and incorporates the entire disclosure of U.S. Provisional Patent Application No. 60/361,901 filed Feb. 28, 2002. 

   BACKGROUND 
   1. Technical Field of the Invention 
   The present invention relates to orthopedic supports and, more particularly, but not by way of limitation, to an orthopedic support for a knee having a hinge that may be adjustably positioned for anatomically correct support of knees and legs of varying sizes and shapes. 
   2. History of Related Art 
   It is common in the Sports Medicine Industry to utilize orthopedic supports for various body parts subject to injury. The most common support areas include the knees, elbows, and ankles. Often injuries to these areas of the body can be treated by the utilization of the appropriate orthopedic support. In the event surgery, rehabilitation is sometimes augmented by the utilization of such supports. 
   The design of orthopedic supports has changed considerably over the past two decades. The types of material used as well as the fastening and hinging mechanisms associated with orthopedic supports have been the subject of considerable study and improvement. U.S. Pat. No. 4,986,264 to Miller, teaches a knee brace having an interior tibial shell and an interior femoral which are closely configured to the shape of the lower leg and thigh respectively and which are joined by a frame in the form of a pair of polycentric hinge joints. U.S. Pat. No. 4,856,501 to Castill et. al. teaches a knee brace having adjustable width frame pivoted to cuffs. The brace as set forth therein includes first and second frame members disposed on opposite sides of the joint to be supported, and first and second hinge members disposed substantially adjacent to joint and connected to the frame members to pivot the frame members about the joint. 
   Another example of related art is shown in U.S. Pat. No. 4,494,534 to Hudson. This patent teaches a universal leg brace system for controlling the degree of motion permitted by wearer&#39;s knee characterized by respective flexible sheets of cushioned material adapted for snugly wrapping around the wearer&#39;s thigh and calf. U.S. Pat. No. 5,554,104 to Grim likewise teaches a custom formed knee brace. This brace is taught to support weakened or injured knees by having formed components which conform to the unique configuration of an individual&#39;s leg surfaces. Other references include U.S. Pat. No. 6,066,110 to Nauert; U.S. Pat. No. 5,810,752 to Grifka; U.S. Pat. No. 5,624,389 to Zepf; U.S. Pat. No. 4,873,967 to Sutherland; U.S. Pat. No. 5,921,946 to Tillinghas; and U.S. Pat. No. 5,562,605 to Taylor. 
   As seen from the patents listed above, the aspect of joint support, flexibility, and rehabilitation have received considerable attention in prior orthopedic support design. One area of continued concern is, however, the adaptability of a single support to human body parts of varying size and shape. For example, knee braces require that the area of the thigh above the knee as well as the area of the leg beneath the knee be securely fitted within the brace. Some legs are shaped differently than others. Some individuals have larger thighs than other individuals and thus various modifications must be made to the particular brace to accommodate large and/or smaller leg portions. This is particularly true when an upper leg portion in the area of the thigh is considerably larger than the portion below the knee. When hinge structures are utilized in conjunction with orthopedic supports for such knees, the appropriate alignment of the oppositely disposed hinges becomes critical. If the hinges are not diametrically opposed one to the other, the appropriate hinge action cannot smoothly occur. In fact, various stresses can be imparted to the orthopedic support as well as the knee when misalignment is present. Such a problem is contrary to the purpose of the orthopedic support and will not maximize efficiency and healing. The alignment of the hinges should, therefore, be a primary consideration in orthopedic support design construction and fitting. The present invention addresses such design manufacturer and fitting issues by providing an orthopedic support with adjustable hinge sections to permit appropriate diametrically opposed hinge alignment therewith to accommodate a variety of a body shapes and sizes. 
   SUMMARY OF THE INVENTION 
   The present invention relates generally to orthopedic supports having hinge elements associated therewith. More particularly, one aspect of the invention includes an orthopedic support facilitating better fit for legs of varying shape, including the cone-shaped leg and the positioning of the support around the thigh. In one aspect of the present invention, hinges disposed for positioning above the patella have unique hook and pile adjustments to fit larger or smaller thighs (from child sizes to adult sizes) and allow proper balanced support on opposite sides of the knee. In another aspect a posterior elastic segment on velcro straps prevent any tourniquet effect. Moreover, the present invention may, in one embodiment, provide a universal right or left leg applicability with removable, adjustable half-horseshoe buttress. 
   Another aspect of the present invention relates to a hinged knee support utilizing adjustable hinges. The knee support is particularly adapted for individuals having larger thigh regions. Thus, the hinged knee support is adapted to open in the upper region thereof to accommodate various sizes and shapes of thigh portions and to further include means for adjustably positioning the lateral hinges so that they are oppositely disposed about knee to provide the most appropriate support, irrespective of the shape and size and 
   In another aspect of the present invention, the present invention includes a large popliteal opening for added comfort by the user. A multitude of hinges may be used including both the single axis and a polycentric type of hinge. 
   In still another aspect of the present invention, a spiral stay may be used so that as the knee is bent by a user, the stay encourages the present invention to return to a neutral position after each movement. In this manner, as the knee is returned to a neutral position such that pressure exerted on the knee neither pushes or pulls the tissues of the knee apart. 
   In yet another aspect of the present invention, hook and pile inter-engagement is used to facilitate the positioning and securement of the hinges in the most appropriate location relative to the knee. 
   And yet a further aspect of the present invention, a hinged knee support is provided with a patient friendly configuration having a closed bottom section for covering the calf of the patient and an upper region that may be open and adjusted to the appropriate size for accommodating a variation in the size of the thigh of the user. The hinged knee further incorporates the adjustable hinge feature as described above therein facilitating structural support of patients having a wide variation of certain anatomical regions thereof. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     A more complete understanding of embodiments of the present invention can be achieved by reference to the following Detailed Description when taken in conjunction with the accompanying Drawings wherein: 
       FIG. 1  is a perspective view of an orthopedic support constructed in accordance with the principles of the present invention; 
       FIG. 2  is an enlarged, side elevation, fragmentary view of the hinged attachment area of the knee support of  FIG. 1  illustrating various positioning of the hinge thereon and a means of for attachment thereto; 
       FIG. 3  is a front elevation view of the knee support of  FIG. 1  illustrating the accommodation of a relatively large thigh therein and the manner of accommodation provided in accordance with the principles of the present invention; 
       FIG. 4  is a front elevation view of the knee support of  FIG. 3  illustrating closure of the kneec thigh and the use of hook and pile closure straps for securement of the knee support to the user&#39;s leg; 
       FIG. 5  is a side elevation view of the knee support of  FIG. 1  further illustrating the construction of thereof; 
       FIG. 6  is a front elevation view of the knee support of  FIG. 1  further illustrating the construction thereof and the positioning of the medial and lateral hinges so that said hinges are anatomically correct relative to the knee of the user; and 
       FIG. 7  is a flow chart illustrating the method of using the present invention. 
   

   DETAILED DESCRIPTION 
   It has been discovered that many commercial braces do not fit certain sizes and shapes in the most appropriate manner. This is particularly true of legs with large thighs and smaller calf regions. These leg shapes are referred to herein as “cone-shaped” legs and illustrated in certain ones of the following drawings. Further, the present invention may be adapted to fit the leg shapes of both children and adults. 
   Referring now to  FIG. 1 , there is shown an adjustable hinged knee support  10  constructed in accordance with the principles of the present invention. The knee support  10  facilitates a better fit for users having large thighs or “cone-shaped” legs  12 . An adjustable upper fastener assembly  14  accommodates the various thigh sizes. As shown in  FIG. 1 , a large patella opening  16  (or alternatively, a large popliteal opening) is also provided for added comfort. On opposite sides of opening  16  are removable, adjustable half-horseshoe buttress&#39;  21  for comfort and support (see also  FIG. 2 ). As described below, the upper fastener assembly  14  and the lower fastener assembly  18  may be constructed with hook and pile portions to facilitate adjustability and ease of use by the user. Still referring to  FIG. 1 , a hinge  20  is distinctly placed along the medial portion of the knee support  10 . Hinge  20  may be either a polycentric (double axis) hinge, single axis hinge, complex hinge, or a spiral stay. Other types of hinges may also be used As will be shown in more detail below, a second hinge  20  is disposed opposite hinge  20 , and is positioned on the outside portion of the knee to balance the support about the knee. It has been observed in prior art that knee braces do not accommodate variations in size of the user&#39;s thigh, the position of the respective hinges may vary in accordance with the principles of the present invention. 
   Referring now to  FIG. 2  there is shown an enlarged fragmentary, side elevation view of an upper portion  22  of hinge  20  of the knee support  10  of  FIG. 1 . The position of the upper portion  22  of hinge  20  is shown to be positionable about a hook and pile surface  24  of the knee support  10 . A retaining strap  26  is shown in a position for securement of hinge  20 . In this manner, the position of the hinge  20  relative to the leg of the user, as shown in  FIG. 1 , may be selectively adjusted to accommodate variations in the size of the thigh of the user. In other words, the medial and lateral hinges (described below) are adjusted to allow the knee support  10  to be anatomically correct relative to the knee. 
   Referring now to  FIG. 3  there is shown the knee support  10  positioned about the leg  12  of a user. In this particular embodiment it may be seen that the thigh  30  is much larger than the calf  32  of the user. For this reason, the knee support  10  is constructed with opposing flaps  34  and  36  which as shown in  FIG. 1 , when closed comprise an upper portion  52  of the knee support  10 . In this particular illustration, it may be seen that the flaps  34  and  36  are in an open position, which permit the fitting of the knee support  10  about the leg  12  of the user. The flaps  34  and  36  are constructed with hook and pile surfaces  38  (one which is shown on flap  34 ) to facilitate securement about the leg  12  of the user. A portion of the hook and pile surface  38  comprises a portion of the adjustable upper fastener assembly  14 , illustrated in  FIG. 1 . The adjustable upper fastener assembly  14  further includes a strap  40  extending outwardly from flap  36 . Still referring to  FIG. 3 , the lower region  50  of the knee support  10 , in this particular embodiment, is of fixed size and thus is not adjustable. The lower region  50  does, however, include a support strap  52  that affords securement of the knee support  10  about the leg  12  of the user. 
   Referring now to  FIG. 4  there is shown the knee support  10  of  FIG. 3  positioned about the leg  12  of the user with the flap  38  closed and positioned over the flap  36  as described above. A region  38   a  of hook and pile material, which is not visible in  FIG. 3 , is illustrated as it appears on the outer portion of the flap  36 . It should be noted that the term “hook and pile fasteners” is a recognized structure to one skilled in the art and is often sold under the trademark Velcro®. It is also well known that the hook and pile enter and engage one another. Therefore, if surface  38 , as shown in  FIG. 3 , is a hook surface then the region  38   a  of  FIG. 4  would be a pile surface. It is to be understood that further reference herein to a “hook and pile surface” refers to either a hook or a pile surface. 
   Still referring to  FIG. 4 , it may be seen that the lower region  50  of the knee support  10  conforms about the calf  32 , with the patella opening  16  more clearly illustrated by the closure of flap  38  over flap  36 . Various stitching  54  is shown upon flap  38  as well as stitching  56  shown around the patella opening  16 . This stitching is shown for purposes of illustration only, and other stitching embodiments maybe incorporated herein. All illustrations thereof should not be deemed limited in any respect relative to the principles of the present invention. 
   Referring now to  FIG. 5  there is shown the knee support  10  with the lower strap  52  securing the lower region  50  of the knee support  10  while the upper fastener assembly  14  secures the upper region of the knee support knee  10  about the leg  12  of the user. It may be seen that the hinge  20  is positioned on the hook and pile surface  24  in a position most appropriate to support of knee of the user as will be described in more detail below. 
   Referring now to  FIG. 6 , there is shown the knee support  10  in a front elevation view. This particular view it may be seen that the hinge  20  comprises medial and lateral hinges  20 . Because the knee brace may be used on either left or right knees, it is not necessary to differentiate which hinge  20  is medial or lateral. This definition is relative to the leg of the user. The present description is intended to provide an understanding that the position of the medial and lateral hinges  20  may be adjusted so that they are anatomically correct. As described above, the ability to adjust the position of the hinges  20 , and the ability to position the upper portion  22  of the hinge  20  about the hook and pile surface  24  against which it may be secured, facilitates anatomically correct adjustment. 
   In one embodiment of the present invention, a sheet of material  60  covers the hinge  20 . The underside of the sheet  60  has a mating hook and pile surface to engage the hook and pile surface  24 , which provides securement of the upper portion  22  of hinge  20  ( FIG. 2 ) thereto. 
   In operation, the present invention accommodates various leg sizes. This is clearly shown in  FIG. 3 , where the above described upper fastener assembly  14  and strap  40  therein described allow the user to position the knee support  10  around the leg  12  of the user in a manner facilitating a wide variety of thigh sizes. Because thigh sizes will vary (especially between children and adults), the knee support  10  of the present invention may be provided in a variety of basic sizes, such as small, medium, large, and extra large, to further provide accommodation of varying leg sizes. 
   Still referring to  FIGS. 1–6  in combination,  FIG. 4  illustrates the anterior hook and pile closure “wrap around” configuration that affords ease in the use of the present invention. However, other fasteners can be used. Likewise  FIG. 5  illustrates the securement of the bottom strap  52  of the present invention around the calf  32  of the user prior to the securement of the upper fastener assembly  14 . This is the preferred method of securing the knee support  10  around the leg  12  of the user. 
   Finally,  FIG. 6  clearly illustrates the ability to adjust the medial and lateral hinges  20  in an anatomically correct configuration relative to the legs of the user. It is necessary to provide the hinges  20  on opposite sides of the user&#39;s knee, no matter the shape of the user&#39;s thigh so as to provide appropriate support about the knee. Thus, the present invention, which utilizes hook and pile adjustable “wrap around” fasteners, provides a better fit for “cone-shaped” legs than those found in the prior art. The large patella opening  16  provides additional comfort, while a posterior elastic segment on the hook and pile straps  40  and  52  ( FIG. 3 ) prevent any tourniquet effect. As described above, the adjustable, hinged knee support  10  with adjustable hinges is interchangeable for use on either the right or left leg. 
   Referring now to  FIG. 7 , the method of using the present invention allows users having different leg sizes and shapes, including a generally cone-shaped upper leg portion to be fitted with an effective knee support. The user positions the open knee support on the user&#39;s leg and adjusts the hinges as described above so as to position each hinge relative to the user&#39;s knees on opposite size thereof. The hook and pile fasteners permit the user to secure the hinge in the position that is most appropriate for the user&#39;s particular leg shape, and further secure the hinge with the straps pulled there around. It is possible to use multiple hinges, and in one aspect of the present invention four different hinges and/or stays may be used. It has been shown to the applicant that not everyone requires a heavy hinge and hinges that simply lockout at either 90 degrees or vertical are in some instances appropriate to prevent hyper extension of the user&#39;s knee. In accordance with the principles of the present invention, the use of a polycentric hinge (a double axis type of hinge) has also been found to be useful. It should be understood, however, that any type of hinge may be used. 
   One advantage of the present invention is the adjustable hinges. This is because adjustable hinges  20 , as is illustrated in  FIG. 2 , allow the user to position the hinges  20  about the hook and pile material so as to position them above the knee wherein the hinges are neither to far interior nor to far posterior prior to final securement. 
   Another advantage is in the use of a flexible spiral stay, which allows use of the knee support  10  for various injuries where it is beneficial for the knee support apparatus to return to a neutral position for proper healing. Spiral stays are made from hardened, galvanized spring steel round wire which is coiled and flattened, and is generally referred to in the trade as “spiral boning”. Such material provides support rigidity for partially immobilizing the knee, yet can be flexed, when placed under pressure, to conform to the body contours of the wearer, as illustrated in  FIG. 5 . 
   Yet another advantage is in the ample strap length provided, which allows a wide range of adjustability relative to the sizes of the user&#39;s leg. Since adjustability is a key aspect of the present invention, straps with hook and pile material are an advantage. 
   Finally, the present invention may be adapted to fit both children and adults. The present invention will be supplied in wide variety of sizes to accommodate the needs of various users. 
   Although an embodiment of the method and apparatus of the present invention has been illustrated in the accompanying Drawings and described in the foregoing Detailed Description, it will be understood that the invention is not limited to the embodiment disclosed, but is capable of numerous rearrangements, modifications and substitutions without departing from the spirit of the invention as set forth and defined herein.