Patent Publication Number: US-2023147111-A1

Title: Versatile orthopedic device

Description:
FIELD OF THE DISCLOSURE 
     The disclosure relates to a versatile orthopedic device, and more specifically to a knee brace arranged in a streamline and efficient manner for a ligament user, and configured to be converted to a knee brace for osteoarthritis treatment. 
     BACKGROUND 
     Typically, orthopedic devices include a frame that comprises at least one support member. When there are multiple support members, the device may include rotational hinges that assist and control movement of the limb. Suitable straps may maintain the brace on the limb, and other features such as pads may relieve pressure of the brace on the limb and surrounding areas. 
     A predominant orthopedic device is a knee brace. Knee braces are used to stabilize the knee by preventing excessive movement of the knee, or to facilitate movement of the knee. Many braces comprise a frame and have hinges on at least one of the lateral and medial sides of the knee joint. Straps are used to secure the brace to the leg or knee. An injured knee can be fit with an “off the shelf” brace or a “custom-fit” brace, with the selection of the brace depending on the size and shape of an individual&#39;s leg. 
     Many knee braces reduce knee instability following an injury, fatigue or to treat impairment of the knee, particularly if the knee has damaged ligaments. Braces may be recommended for walking, skiing, running, twisting, pivoting, or jumping activities. Besides providing increased stability to the knee, braces may also decrease the risk of injuring the knee or leg, or provide corrective assistance to the knee. 
     To maximize its supportive, protective and comfort aspects, it is desirable that a knee brace securely and precisely fit the leg of the wearer. While custom-fit braces are made to closely conform to the exact geometry of a leg of a wearer, it is common for the geometry of the leg to change over time requiring even a custom-fit to accommodate a variety of geometries of the leg. As for off-the-shelf braces, these braces must be configurable to accommodate a variety of leg geometries irrespective of the particular geometry of a leg. 
     In recognizing the need for effective knee braces, various knee braces have been introduced to the marketplace. Such knee braces, however, have comprised relatively heavy, bulky apparatuses that fail to provide ventilation and evenly distribute pressure from the brace on the leg of the wearer. Many contemporary braces are deficient because the braces do not consistently provide or lack adjustment features for forming a firm, comfortable and secure interface between the leg and knee of the wearer and the brace. Because of these drawbacks, many knee braces detract from the user&#39;s endeavor. 
     The features of the embodiments described are provided in recognition of the need for orthopedic braces and components for use therewith that are adjustable in both custom-fit and off-the-shelf braces to achieve superior functional performance characteristics while being comfortable to the wearer when worn. This recognition is realized with the embodiments described. 
     Knee braces are widely used to treat a variety of knee infirmities. Such braces may be configured to impart forces or leverage on the limbs surrounding the knee joint to relieve compressive forces within a portion of the knee joint, or to reduce the load on that portion of the knee. If knee ligaments are weak and infirm, a knee brace may stabilize, protect, support, unload, and/or rehabilitate the knee. 
     The knee is acknowledged as one of the weakest joints in the body, and serves as the articulating joint between the thigh and calf muscle groups. The knee is held together primarily by small but powerful ligaments. Knee instability arising out of cartilage damage, ligament strain and other causes is relatively commonplace since the knee joint is subjected to significant loads during the course of almost any physical activity requiring using the legs. 
     A healthy knee has an even distribution of pressure in both the medial and lateral compartments of the knee. It is normal for a person with a healthy knee to place a varus moment on the knee when standing so the pressure between the medial and lateral compartments is uneven but still natural. 
     One type of knee infirmity that many individuals are prone to having is compartmental osteoarthritis. Compartmental osteoarthritis may arise when there is a persistent uneven distribution of pressure in one of the medial and lateral compartments of the knee. Compartmental osteoarthritis can be caused by injury, obesity, misalignment of the knee, or due to aging of the knee. 
     A major problem resulting from osteoarthritis of the knee is that the smooth cartilage lining the inside of the knee wears away. This leads to a narrowing of the joint space with developing cysts and erosions in the bone ends. Because of the narrowing of the joint, bone comes directly in contact with bone, and an uneven distribution of pressure develops across the knee which may cause the formation of bone spurs around the joint; all ultimately lead to increasing pain and stiffness of the joint. 
     While there are no cures to osteoarthritis, there are many treatments. Individuals who have a diagnosis of isolated medial or lateral compartmental osteoarthritis of the knee are confronted with a variety of treatment options such as medications, surgery, and nonsurgical interventions. Nonsurgical interventions include using canes, lateral shoe wedges, and knee bracing. 
     Knee bracing is useful to provide compartmental pain relief by reducing the load on the affected compartment through applying an opposing external valgus or varus moment about the knee joint. Unloading knee braces have been shown to significantly reduce osteoarthritis knee pain while improving knee function. 
     While known knee braces succeed at reducing pain or at stabilizing a knee joint, many users find these braces to be bulky, difficult to don, complicated to configure, and uncomfortable to wear. Embodiments of the disclosure have streamlined features capable of providing relief for medial or lateral compartmental osteoarthritis, or functional stability of the knee while providing a configuration that has a low profile and unexpectedly provides a more conforming and supportive fit for the orthopedic device. 
     SUMMARY 
     Various embodiments described are directed to a versatile orthopedic device arranged to convert between ligament and osteoarthritis treatment, and to accommodate a variety of leg anatomies. According to the embodiments, the orthopedic device is configured as a double-upright brace indicating struts, frame component sections and associated hinges preferably intended to be along both medial and lateral sides of a wearer&#39;s leg. 
     The embodiments are arranged to be cold-formed by a clinician to conform to the individual anatomy of the wearer. Frame components are formed from a metal, such as an aluminum alloy, that will permit “cold-forming” while maintaining sufficient integrity to withstand forces exerted by the wearer. Cold-forming implies that the frame components do not require heating for reshaping, but rather can be bent by suitable means to cater to individual anatomies while retaining sufficient structural integrity while being worn by a user without yielding to various forces exerted by the wearer. 
     Different frame components and other elements may be formed from materials exhibiting different strengths and other properties enabling the clinician to custom form the device according to specific needs of a wearer. Either or both medial and lateral sides may be reinforced with struts having strength greater than a frame component to increase medial-lateral stability. 
     The ability to cold-form the frame allows the device to be sold as an off-the-shelf product without the need for fabricating each individual device for an individual anatomy. The device is versatile in the manner of accommodating a variety of anatomies and indications, and may be custom-made as well. 
     Embodiments may include slots formed on struts that allow a clinician to resize the length of the device to permit short, standard or long versions of the device, and potentially reduce hinge binding on osteoarthritis patients. 
     In addition to resizing and modifying the shape of the frame components, the device includes means for additionally accommodating anatomy of the leg. The device may include a tibia pad adapted to conform to part of the shape of the second frame component and be adjustable in location along the second frame component to correspond to the tibia of an individual wearer of the brace. As the medial side of the anterior aspect has a generally flat profile corresponding to the tibia and periosteum, and the lateral side has a rounded profile corresponding to the lateral muscle compartment, the second frame component can be contoured due to its malleability to the lower leg. It may be difficult to obtain an accurate match for an individual user along the second component, and the tibia pad can fill the void of the medial side of the second component between the leg and orthopedic device without requiring guesswork of shaping the second frame component itself. 
     The embodiments preferably have a streamlined and short profile to allow a wearer freedom of movement and reduce weight of the device. The embodiments may enable a short brace ranging from a distance from an outer peripheral edge of the first frame component to an outer peripheral edge of the second frame component when the orthopedic device is in full extension and is about or less than 45 cm. A combined thickness of the first extension and the first strut defining an upright is about or less than 10 millimeters. A thickness of the first frame component extending about a leg may be about or less than 5 millimeters. 
     A strap kit and method for installing the orthopedic device includes an osteoarthritis strap kit arranged for securing to a basic frame of the orthopedic device by a subshell system. The subshell system, which may be configured as more flexible than the basic frame, is adapted to evenly distribute pressure about a user&#39;s anatomy. 
     The orthopedic device is preferably modular in design to treat a variety of indications, including ACL (anterior-collateral ligament), MCL (medial-collateral ligament), LCL (lateral-collateral ligament) and posterior-collateral ligament (PCL), rotary and combined instabilities; mild to severe ligament laxity, sprain or deficiency; protection and stabilization of ligaments after surgical repair or reconstruction; medial or lateral compartment unloading for unicompartmental osteoarthritis or articular cartilage healing; post-operative rehabilitation and functional support plus unloading protocols requiring medial or lateral joint loads during recovery; functional support with or without varus/valgus alignment; and contact and impact activities. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The orthopedic device is described regarding the accompanying drawings which show preferred embodiments according to the device described. The device as disclosed in the accompanying drawings is illustrated for example only. The elements and combinations of elements described below and illustrated in the drawings can be arranged and organized differently to result in embodiments still within the spirit and scope of the device described. 
         FIG.  1    is a perspective view of an embodiment of an orthopedic device. 
         FIG.  2 A  is a front elevational view of a first frame component in an upper frame assembly of  FIG.  1    in a non-contoured configuration. 
         FIG.  2 B  is a front elevational view of a strut for the upper frame. 
         FIG.  3 A  is a perspective view of a first frame assembly in the embodiment of  FIG.  1   . 
         FIG.  3 B  is a schematic view of adjustment of the first frame assembly in the embodiment of  FIG.  1   . 
         FIG.  4 A  is a front elevational view of a second frame component for an embodiment of the orthopedic device in a non-contoured configuration. 
         FIG.  4 B  is a front elevational view of a variation of the second frame component in  FIG.  4 A  in a non-contoured configuration. 
         FIG.  4 C  is a side elevational view of the second frame component in  FIG.  4 C . 
         FIG.  5 A  is a side elevational view of a hinge assembly embodiment. 
         FIG.  5 B  is a rear schematic portion view of the hinge assembly of  FIG.  5 A . 
         FIG.  5 C  is a front schematic portion view of the hinge assembly of  FIG.  5 A  without various hinge components. 
         FIG.  5 D  is a perspective schematic view of a hinge assembly in  FIG.  1    and including the first frame assembly of  FIG.  2 A  and the second frame component of  FIG.  4 B . 
         FIG.  6 A  is a plan view of a first subshell for use with the first frame component of  FIG.  2 A . 
         FIG.  6 B  is an elevational view of the first subshell of  FIG.  6 A . 
         FIG.  7    is a plan view of a second subshell for use with the second frame component of  FIG.  4 B . 
         FIG.  8 A  is a perspective view of modification of the first frame assembly of  FIG.  2 A  with an osteoarthritis strap kit. 
         FIG.  8 B  is a perspective view of modification of the second frame assembly of  FIG.  4 B  with an osteoarthritis strap kit. 
         FIGS.  8 C- 8 F  are perspective views showing modification of the orthopedic device of  FIG.  1    with an osteoarthritis strap kit. 
         FIG.  9    is a schematic view showing a cross-section of a lower leg. 
         FIG.  10    is a schematic frontal view of adjustment of the tibia pad of  FIG.  9    relative to the second frame component of  FIG.  4 A . 
         FIG.  11    is a schematic top view showing the tibia pad relative to the second frame component and a liner. 
         FIG.  12 A  is a perspective view of a tibia pad for use in the orthopedic device. 
         FIG.  12 B  is an elevational view of the tibia pad of  FIG.  9   . 
         FIG.  13    is an elevational view of a tibia strap pad of the orthopedic device. 
     
    
    
     DETAILED DESCRIPTION OF THE VARIOUS EMBODIMENTS 
     A. Overview 
     A better understanding of different embodiments of the disclosure may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements. 
     While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are shown in the drawings and are described below. It should be understood, however, there is no intention to limit the disclosure to the embodiments disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, combinations, and equivalents falling within the spirit and scope of the disclosure. 
     It will be understood that, unless a term is defined in this disclosure to possess a described meaning, there is no intent to limit the meaning of such term, either expressly or indirectly, beyond its plain or ordinary meaning. 
     Any element in a claim that does not explicitly state “means for” performing a specified function, or “step for” performing a function, is not to be interpreted as a “means” or “step” clause as specified in 35 U.S.C. section 112. 
     B. Definitions 
     For ease of understanding the disclosed embodiments of an orthopedic device, the anterior and posterior portions of the orthopedic device are described independently. The anterior and posterior portions of the orthopedic device function together to support and stabilize anatomical portions of the wearer of the device. 
     For further ease of understanding the embodiments of an orthopedic device as disclosed, a description of a few terms is necessary. As used, the term “proximal” has its ordinary meaning and refers to a location next to or near the point of attachment or origin or a central point, or located toward the center of the body. Likewise, the term “distal” has its ordinary meaning and refers to a location situated away from the point of attachment or origin or a central point, or located away from the center of the body. The term “posterior” also has its ordinary meaning and refers to a location behind or to the rear of another location. The term “anterior” has its ordinary meaning and refers to a location ahead of or to the front of another location. 
     The terms “rigid,” “flexible,” “compliant,” and “resilient” may distinguish characteristics of portions of certain features of the orthopedic device. The term “rigid” should denote that an element of the device is devoid of flexibility. Within the context of frame or support members or shells that are “rigid,” it should indicate that they do not lose their overall shape when force is applied, and they may break if bent with sufficient force. The term “flexible” should denote that features are capable of repeated bending such that the features may be bent into retained shapes or the features retain no general shape, but continuously deform when force is applied. 
     The term “compliant” is used to qualify such flexible features as conforming to the shape of another object when placed in contact therewith, via any suitable natural or applied forces, such as gravitational forces, or forces applied by external mechanisms strap mechanisms. The term “resilient” is used to qualify such flexible features as returning to an initial general shape without permanent deformation. As for the term “semi-rigid,” this term is used to connote properties of support members or shells that provide support and are free-standing; however, such support members or shells may have some degree of flexibility or resiliency. 
     C. Various Embodiments of the Orthopedic Device and Components for Use Therewith 
     According to an embodiment of the disclosure illustrated in  FIG.  1   , a versatile orthopedic device  10  includes a basic frame including a first frame component  12  defining first and second extensions  24 ,  26  and a center section  28  spanning between the first and second extensions  24 ,  26  and having a center line  30 ; a second frame component  14  defining first and second extensions  36 ,  38  and a center section  40  spanning between the first and second extensions  36 ,  38 ; and a hinge assembly  400  including first and second hinges or joints  20 ,  22  connecting the first and second frame components  12 ,  14  by first and second struts. 
     The second frame component  14  may define a flattened region  32  preferably located between the center section  40  and one of the first or second extensions  36 ,  38 . The opposing side preferably does not include such flattened region. This flattened region is a solution for solving the problem of the anatomy of the medial side of the lower leg in relation to the discussion on  FIG.  9   , and as discussed in connection with another solution discussed in connection with  FIGS.  10 - 13   . Rather than including an insert, as in  FIGS.  10 - 13   , the lower frame component  14  is permanently deformed to the medial side of the lower leg. 
     The hinges may be selected from a variety of hinges found in orthopedic devices. An exemplary hinge is described in U.S. Pat. App. Pub. 2012/0059296, published Mar. 8, 2012, or U.S. Pat. No. 7,597,675, granted Oct. 6, 2009, and incorporated in its entirety by reference. 
     The basic frame forms a “double upright” brace or “cage-style” device adapted as a knee brace. While the exemplary embodiment shows the first frame component in a proximal location along an anterior side and a second frame component in a distal location also along an anterior side, the basic frame is not limited to this configuration. The first frame component can be arranged along an anterior side, while the second frame component can be arranged along a posterior side to form a “step through design.” Both the first and second frame components may be arranged along the posterior side. 
     Suitable padding may be provided along the frame portions of the orthopedic device. The padding may be constructed in a variety of types, and a preferable padding is edge bound and thermoformed. The padding preferably extends beyond the periphery of the frame components to minimize discomfort and assure the wearer&#39;s anatomy is sufficiently protected. An exemplary padding may be found in U.S. Pat. No. 8,585,623, granted Nov. 19, 2013 or U.S. Prov. App. No. 62/103,678, filed Jan. 15, 2015, incorporated herein by reference. 
     In a variation, the orthopedic device  10  has first and second struts  16 ,  17  securing to and overlapping the first and second extensions  24 ,  26  of the first frame component  12  and securing to the first and second hinges  20 ,  22 . In a variation, the orthopedic device  10  also includes first and second struts  18 ,  19  securing to and overlapping the first and second extensions  36 ,  38  of the second frame component  14 . The overlap  25  may be the entirely or substantially along the length of the extension of the first and second frame components. As it is desired to maintain a streamlined configuration, a combined thickness of the extensions and the first struts may be about or less than 10 millimeters. 
     Various removable fasteners  76 ,  78 , such as Chicago screws, are used to secure the struts to the frame components. Any of the struts  16 ,  17 ,  18 ,  19  may include an adjustment system, such as slots (as shown as  37  in  FIG.  1    or in  FIG.  5 A ) to enable lengthening or shortening the orthopedic device along length  23 . A distance  23  from an outer peripheral edge  27  of the first frame component  12  to an outer peripheral edge  29  of the second frame component  14  when the orthopedic device is in full extension (knee is in 0 degrees of flexion) is about or less than 45 cm. 
     The adjustment system may, in part, allow for correction of leg curvature by forming a lateral inward or outward angle of the upper frame in relation to the lower frame, as discussed in U.S. Pat. No. 6,875,187, granted on Apr. 5, 2005, in relation to the securable slidable engager described, and U.S. Pat. App. Pub. No. 2013/0144197, published Jun. 6, 2013, incorporated herein by reference. 
     In an exemplary embodiment, the first strut  16  defines an elongate slot at a first end (generally in the proximal direction), and the fasteners  76 ,  78  extend through openings defined by the first frame component and the slot. When the fasteners are loosened, the first strut is slidable relative to the first frame component and secured to the first frame component without movement by regulation of the first fastener. 
     The first and second frame components are preferably constructed from aluminum and may be malleable from a cold forming treatment to allow for easy customization of the frame elements to a particular leg shape. Other exemplary materials that may be used for constructing the frame include metals such as titanium, and steel, thermoset resin composite systems including glass or carbon fibers, and thermoplastics rendered rigid by way of material composition and geometry of the frame members. The first and second frame components may be formed from different materials or materials having different properties such as strength and rigidity and are not limited to be formed from the same materials. 
     The struts are preferably constructed from a malleable material such as an aluminum alloy. The struts may be constructed from an aluminum alloy stronger than an aluminum alloy forming the first frame component. The frame components may be constructed from aluminum alloys 5052 or 6061, and the struts may be formed from the same alloys or stronger alloys. The clinician can select which types of struts to use on the basis of the needs of a wearer such that the orthopedic device may be furnished as a strap kit with a selection of different struts available for the clinician to use. The struts are not limited to being selected from the same material but each strut or pairs of struts may have a material different from another depending on the indications of an individual wearer. 
     Even if the frame components and the struts are formed from the same or substantially same materials, the struts may be extended along an inner surface of the extensions and reinforce the frame components. This arrangement provides flexibility in tailoring the rigidity of the lateral and medial sides of the orthopedic device, and eliminates permanently fixing the rigidity of sides of the orthopedic device in that the struts may be removed and switched as desired. 
     Suitable straps  46 ,  58 ,  60 ,  74  may depend from the first and second frame components  12 ,  14 . D-rings or suitable means  62  may be pivotally secured by fasteners  64  to the frame components. A tibial strap  46  may extend between the first and second extensions  36 ,  38 , and include a cover or sleeve to cover any strap ends or other items forming part of or protruding from the strap  46  to provide a streamlined appearance. 
     In the embodiment of  FIG.  1   , an osteoarthritis strap kit  48  secures to the basic frame. In a variation shown in  FIG.  2 A , the strap  48  includes a hook element  54  securable to a keyhole  56  formed along the center section  28  at a first side of the first frame component  12  and spirals the first side of second frame component  14  while crossing over to the second side generally proximate the second hinge  22 . 
     A flexible subshell  66  may secure to first frame component  12 . The flexible subshell is secured to the first frame component  12 , and has a first end extending laterally beyond the first side portion to flex relative to a side portion of the first frame component. The subshell may have a contoured edge extending beyond the peripheral contour to flex relative to the frame peripheral contour. The subshell may be mounted along an interior surface of the first frame component. The strap  58  may secure to or over the subshell  66  to evenly distribute pressure over the wearer&#39;s anatomy. 
     The subshell  66  may selectively attach to the first frame component  12  and has protrusions extending through slots formed by the first frame component  12  to prevent pivoting of the subshell  66  relative to the first frame component. The fastener  64  for the D-ring  62  may extend through the subshell  66  to prevent it from slipping away from the first frame component. Subshells may be attached at any portion of the first and second frame components and the method described above is merely exemplary. 
     The osteoarthritis strap kit transforms the orthopedic device into an unloading type knee brace, under the principles described in U.S. Pat. No. 7,198,610, granted Apr. 3, 2007, and U.S. Pat. No. 5,277,698 granted Jan. 11, 1994, both incorporated in their entirety by reference. The strap may be a strap tightener assembly for a strap assembly for an orthopedic device discussed in U.S. Pat. App. Pub. No. 2013/0184628, published Jul. 18, 2013, and incorporated in its entirety by reference. 
       FIGS.  2 A- 4 B  depict alternative embodiments of the first and second frame components  111 ,  114 , respectively, in a flat condition prior to contouring, unlike in  FIG.  1   , and hence are in a non-contoured configuration, or in a contoured configuration, as noted. The first and second frame components  111 ,  114  are arranged similarly as the components in  FIG.  1   . It will be noted in the following examples that the first frame component  111  embraces both the first or upper frame, and the struts for each side of the first frame. For simplicity, a single strut is described by such strut may be oriented or adapted for both sides of the first frame  112 . 
     Referring to  FIG.  2 A , the first or upper frame  112  of the first frame component  111  defines first and second extensions  124 ,  126  and a center section  128  spanning between the first and second extensions  124 ,  126  and having a center line  130 . The center line  130  defines a location of the center section  128  having a shorter height  142  than areas outside of the center line  130 . The shorter height  142  facilitates bending of the center portion  128  by a clinician to customize the contour of the center section  128  to an individual wearer. 
     The center section  128  forms a dip or slight gradual swoop  152  toward the center line  130  from corners  132 ,  134  defined at the junction of first and second sides of the center section  128  and the first and second extensions  124 ,  126 , respectively. The dip  152  provides contouring to the anatomy of the wearer and enables a pleasing aesthetic appearance. 
     The first and second extensions  124 ,  126 , which are along the longitudinal length of a leg, are oriented at an angle less than 90 degrees in the pre-contouring condition to better approximate the anatomy of the wearer. As the orthopedic device is streamlined and minimal in size, the length of the first and second extensions  124 ,  126  are preferably short, as denoted by length  154 . The length  154  (taken from inner corners  150 ) of the extensions  124 ,  126  may be shorter than a length  153  of the center section  128  from the inner corners  150  to the center line  130 . If desired to lengthen the orthopedic device, regulation of the position of the struts (as discussed in relation to  FIG.  1   ) may be had by adjusting the slot of the struts relative to positioning holes  144  on the extensions  124 ,  126  for receiving fasteners. 
     The first frame  112  defines first and second wing sections  132 ,  134  opposite the corners  150  and extending in an opposite direction to the center section  128 . The wing sections  132 ,  134  provide extra material and area to the first frame  112  to accommodate various attachments such as D-rings for supporting straps and subshells. The wing sections  132 ,  134  extend from the inner corners  150  to outer corners  146 , and have apertures  148  for securing D-rings, slots  170  for easing bending for contouring the first frame component  111 , ventilating the frame component, and coupling to a subshell. 
     Turning to  FIG.  2 B , the strut  116  (which may comprise the shape of either strut  16  or strut  17  in the embodiment of  FIG.  1   ) includes a first end  121  contoured to fall within the width of the first and second extensions  124 ,  126 , and a second end  123  having a gear profile  125  for forming part of a hinge, as shown in  FIG.  5 D . The second end  123  also defines an extension stop  119  for limiting extending of the hinge, and an opening  122  for forming part of the hinge, as discussed in more detail in relation to  FIG.  5 D . 
     An elongate slot  118  extends downwardly from the first end  121  toward the second end  123 . The elongate slot  118  is adapted to receive fasteners, as shown in  FIGS.  3 A and  3 B , and permit sliding movement of the strut  116  relative to the extensions and affixation thereof at a desired location along the extensions. Indicia  120  are provided along the length of the slot  118  to enable a clinician understanding of relative lengths of both struts, as in the embodiment of  FIG.  1   . 
     Referring to  FIG.  3 A , a coupling part  129  is located on a first or inner side of the strut  116 , and the extensions of the first frame  112 , such that the strut  116  located between the coupling part  129  and a corresponding one of the extensions. The coupling part  129  defines a D-ring portion  131  having a slot  133  for receiving a strap. The D-ring portion  131  extends toward and/or beyond the periphery of the first frame component  112  and flexibly therefrom for receiving a strap. Both lateral and medial, or first and second sides of the first frame component  112  include coupling parts  129 , and a strap extends therebetween. 
     While a D-ring may be formed from the strut  116  material itself and be integrated therewith, the coupling part  129  is advantageous in that it can be adjusted in height according to the location of the strut relative to the extensions. This enables a floating adjustment of the D-ring and corresponding strap according to the height of the first frame component as a whole. 
     The coupling part  129  defines a head portion  137  that has a width less than a width of the strut but greater than the slot  118 . The head portion  137  defines a recessed portion  139  that may have an elongate configuration oriented generally parallel to the slot  118 . The recessed portion  139  further defines at least one aperture  141  for receiving at least one fastener  143 ,  145  that is arranged to extend through the coupling part  129 , slot  118  and the extension. The recessed portion  139  is arranged to minimize projection of the at least one fastener  143 ,  145  into or against the user of the orthopedic device. One end of the at least one fastener is retained or abuts the coupling part  129  within the recessed portion  139  and another end of the at least one fastener engages an outer side of the extension. 
     The coupling part  129  is preferably formed from a single and continuously monolithic piece to maintain stabilization as both support with the head portion  137  for the at least one fastener and height adjustment of the first frame component  111 , and for maintaining the strap between opposed sides (i.e., medial and lateral) of the first frame component even when the height of the first frame component is adjusted in height. A hinge or thinned portion  135  from the material forming the coupling part is located between the D-ring portion  132  and the head portion  137  for permitting some laxity or adjustability of the coupling part when tensioning a strap carried by coupling parts. The D-ring and the head portions  133 ,  137  may be substantially rigid, particularly the head portion  137  for securely receiving the at least one fastener, whereas the hinge portion  135  is flexible at least in part due to its thinned profile. 
       FIG.  3 B  shows that the at least one fastener  143 ,  145  is loosened by a tool T from the outer side of the extension for height adjustment of the first frame component  111 . The at least one fastener is preferably retained between the coupling part  129 , the struts  116  and the extensions  124 ,  126 . A clinician can adjust the height when the at least one fastener  143 ,  145  is loosened, and tighten at a desired setting by referring to the indicia on the strut. 
     As illustrated in  FIG.  4 A , an embodiment of the second frame component  114  defines first and second extensions  136 ,  138  and a center section  140  spanning between the first and second extensions  136 ,  138 . The second frame component  114  may have positioning holes  156  for receiving fasteners securing to struts (not shown), slots  158  for securing to subshells, and apertures  160  for securing D-rings. The second frame component  114  may be configured to include struts, as in  FIG.  2 B , adjusting the height of the second frame component, and may be similarly arranged as with the struts for the upper frame component. 
     Alternatively, the center section  128  may have a uniform height, as shown in the second component  114  by way of uniform height  162  along the center section  140 . The center section  140  of the second frame component  114 , however, may likewise have similar features as the center section  128  of the first frame component such as the variable height and dip. 
       FIG.  4 B  shows a variation of the second component  314 . The second component  314  includes first and second extensions  336 ,  338  and a center section  340  spanning therebetween. Unlike in the embodiment of  FIG.  4 A , the first and second extensions  336 ,  338  are substantially upright, generally forming a right angle relative to the center section, and do not exhibit the angled or acute angle arrangement of  FIG.  4 A . 
     A fillet  342  exists between each of the first extension  336  and the center section  340 , and the second extension  338  and the center section  340 , to provide a wider transition between the sections. As in the first component, the center section  340  tapers in height  364  toward a center point  366  of the center section  340  relative to the extension of the first and second extensions  336 ,  338 . In addition, the width  362  of the center section  340  tapers toward the center point  366  to reduce the weight of the center section and minimize extension of the center section along the leg, as it is desirable the orthopedic possesses a streamlined footprint over the leg of a wearer. The first component may likewise have its center portion adapted similarly to the second component of  FIG.  4 B . 
     To minimize the features added to the frame component, either of the frame components can have slots for receiving various straps. In the example of  FIG.  4 B , the second frame component  314  has slots  346 ,  347  adapted for receiving a tibia strap, as shown in  FIG.  1   . The second component  314  defines slots  358  for securing to subshells, and apertures  360  for securing D-rings. 
       FIGS.  4 B and  4 C  depict the second frame component  314  as having an indent  344 , preferably formed on the medial side of the orthopedic device. The indent  344  is adapted for conforming to the anatomy of the leg on the medial side as this configuration tracks the natural curvature of a medial leg. 
     The second frame component  314  may include end portions  348  at the first and second extensions  336 ,  338 , that are adapted to directly engage the hinge assembly and forms part of the hinge in a polycentric hinge arrangement as evidenced by the gear profile. The end portions  348  may include apertures  341  through which a pin of a hinge engage. The end portions  348  can be modified to receive hinge covers  406 ,  408 , as used in the hinge assembly  400  of  FIG.  5 C , such that the hinge covers  406 ,  408  are adapted for engagement. 
     In the illustrated embodiment, the end portions  348  include a gear profile  349 , and an extension stop  350 , as in the upper frame  112 . Such configuration is preferably used in the hinge variation of  FIG.  5 D . 
       FIGS.  5 A and  5 B  illustrate a hinge assembly  400  that may be used in the orthopedic device, and enables securing of the first and second frame components  112 ,  114  at various locations. The hinge assembly  400  is preferably provided on both sides of the orthopedic device. 
     The hinge assembly  400  includes first and second struts  402 ,  404  having first and second end hinge covers  406 ,  408 , respectively. The first and second struts  402 ,  404  are secured to one another by an outer plate  410  and an inner plate  412 , connecting via hinge fasteners or pins  424 ,  426 ,  428  and  430 . A rotation stop  20 , having a variety of geometries depending on the desired rotation, is insertable between the first and second hinge covers  406 ,  408 . A condyle plate  416  may secure to the inner side of the hinge assembly  400 , and a suitable pad may be secured to the condyle pad. The hinge components described above may function similarly to the hinge described in U.S. Pat. App. Publ. No. 2012/0059296, published on Mar. 8, 2012, and incorporated by reference. 
     The struts  402 ,  404  preferably form protrusions  419 ,  421  forming strap slots  420 ,  422 . In the depicted embodiment, the protrusions extend from opposing sides of the hinge assembly  400  to receive the posterior upper leg strap  74  in  FIG.  2   , and the anterior lower leg or tibial strap  46 , in  FIG.  1   . The upper leg strap  74  and the lower leg strap  46  counteract with one another to retain, at least in part, the orthopedic device on the leg of the wearer. The protrusions  419 ,  421  preferably are arranged to extend sufficiently beyond the first and second frame components so the frame components do not interfere with the straps regardless as to the height position the first and second frame components secure to the hinge assembly, and specifically the first and second struts  402 ,  404 . The protrusions  419 ,  421  eliminate the need for additional features, such as b-rings, to be assembled to the hinge assembly. 
     The first strut  402  shows how the hinge assembly  400  may be adjustably secured to the first component. The first strut  402  includes a slot  418  permitting height adjustment of the first component relative to the strut assembly  400  such that the fasteners  76 ,  78  may be adjustably secured and tightened at a preferred height for an individual user of the orthopedic device. The strut assemblies at both the lateral and medial sides of the orthopedic device may include the slot  418  for uniform, symmetric height adjustment or asymmetric height adjustment depending on the user&#39;s leg anatomy and length. The second strut  404  may likewise include a slot similar to the slot  418  for height adjustment of the second frame component relative to the hinge assembly. 
     In the event the orthopedic device is converted for use as an osteoarthritis brace, the fasteners  76 ,  78  may be loosened yet still engaging the hinge assembly and the first frame component so that they are slidable and securable against each other, as taught in U.S . Pat. No. 6,875,187. The motion enable and variable angular relationship can be modified to treat inward or outward leg curvature through correction of the knee joint orientation. Alternatively, the fasteners may be secured to maintain an angular mismatch relative to the hinge assembly on an opposite side of the leg. 
       FIG.  5 D  illustrates a hinge assembly  450  in combination with the first frame component of  FIG.  3 A  and the lower frame component of  FIG.  4 B . The hinge assembly  450  is beneficial in that it employs the frame components themselves and reduces parts for orthopedic device as a whole. The gear profiles  125 ,  349  of the first and second frame components, respectively, engage one another and are biased or enabled for rotation by rivets  472 ,  474  extending through the openings  122 ,  341 , respectively. The rivets  472 ,  474  may be received by bearing rings  462 ,  464  located within the openings  122 ,  341 , and arranged for facilitating rotation of the first and second frame components. Plates  454 ,  468  may serve as bearings or washers for stabilizing movement of the first and second frame components relative to the hinge assembly and inner and outer covers  452 ,  470  provide anchoring for the rivets  472 ,  474 . An extension or flexion stop  456  may be securable to the hinge assembly  450  and by being engaged to the plates  454 ,  468  by a fastener  453 . The extension or flexion stops can be arranged as in U.S. Pat. App. Pub. No. 2012/0059296. 
       FIG.  6 A  shows an exemplary embodiment of a subshell  166  that may be attached to the first frame  111  of  FIG.  3   , and be used to support a first end of a strap tightener assembly to eliminate the need for any key-hole or similar provisions in the frame components. The periphery or profile  192  of the subshell, at least at a rearward side, should extend beyond the corresponding frame component with the strap tightener assembly, particularly for an upper leg. 
     The subshell defines a plurality of slots  168  at a rear end to facilitate bending of the sub shell and ventilate the sub shell over the wearer&#39;s anatomy as the sub shells are preferably intended to spread over a greater area of a wearer&#39;s anatomy to evenly distribute pressure. The subshell  166  defines an aperture  182  for receiving a fastener (as discussed regarding  FIG.  2   ) to assure the subshell secures to the frame component. The subshell  166  likewise may define a key-hole  184  having a larger portion  186  for receiving a hook element (as in  FIG.  1   ) of the strap tightener assembly, and a smaller portion  188  for locking the hook element with the subshell  166 . A reinforcing edge  190  may be provided about the smaller portion  188  to reinforce the subshell  166  whereat the strap tightener assembly may pull at its greatest. 
     Referring to  FIG.  6 B , the subshell  166  may include locking elements  172  for engaging the through-extending slots  170  defined by a corresponding frame component. The locking elements  172  may include protruding necks  194  with a head portion  196  adapted to snap through and connect to the material of the frame component about the through-extending slot. While shown as being elongate, the locking elements may be formed from a variety of shapes. 
       FIG.  7    depicts a second subshell  200  for attachment to the second frame component  114  of  FIG.  4   , and has a periphery or profile  210  adapted to anatomy of a lower leg. The second subshell  200  includes a key-hole  206  similar to the first subshell, and slots  202 , locking elements  204 , and an aperture  208 . 
     A method of converting an orthopedic device from a ligament brace to an osteoarthritis brace in any of the aforementioned embodiments may include securing first and second subshells to a first side of the first component and the second component; attaching a first end of a strap to the first subshell, spiraling the strap across a second side of the first component opposite the first component and extending the strap to the second subshell; and attaching a second end of the strap to the second subshell. 
       FIGS.  8 A and  8 B  exemplify how the first and second subshells  166 ,  200  couple to the first and second frame components  111 ,  114  for coupling the osteoarthritis strap kit  48  to the orthopedic device  10  in  FIG.  1   . The strap kit  48  may have a hook element  54  that engages a keyhole  184  of the first subshell  166 . 
     Referring to  FIG.  8 A , the locking elements  172  engage the first frame  112  by the through-extending slots  170 . A fastener assembly may be arranged for securing the subshell  166  to the first frame  112 , as taught in U.S. Pat. App. Pub. 2013/0331751, published on Dec. 12, 2013. The fastener assembly includes a first cap  171  that extends through the aperture  148  to engage a second cap  173  arranged for receiving a post or male portion of the first cap  171  by a female portion of the second cap  173 . A fastener  169  secures the first and second caps  171 ,  173  to one another, and retains the subshell  166  to the first frame  112 . 
     The subshell  166  is mountable to either of first or second sides of the first frame  112 . A D-ring assembly  167  may be located on an opposed side of the first frame  112  where the subshell  166  is not located, whereas the subshell  166  includes a slot  191  for receiving a strap which may span between the subshell and the D-ring assembly. The area of the subshell having the slot  191  preferably extends beyond the first frame and the area may have some flexibility to permit better tensioning of the strap against a leg of a user. Coupling parts including D-ring portions  127 ,  129  may likewise be located below the subshell and or be formed by the aforementioned coupling parts in  FIGS.  3 A and  3 B . 
     The subshell  200  is similarly arranged as the subshell  166  and with locking elements  204  engaging or being retained by slots  358 . A corresponding D-ring assembly  181  may operate with the subshell  200  to support a strap. D-ring assemblies  177 ,  179  may be located above the subshell for securing a supplementary strap. A buckle assembly  189 , as taught in U.S. Pat. No. 7,198,610 may form part of the strap kit  48 , and engage a keyhole  206  of the subshell  200 . 
       FIGS.  8 C- 8 F  exemplify how the strap kit  48  may be arranged to treat medial or lateral compartmental osteoarthritis in the orthopedic device  10 . In  FIGS.  8 C and  8 D , the strap kit  48  is arranged to exert unloading on a first side of the orthopedic device, whereas  FIGS.  8 E and  8 F  exert unloading on a second side of the orthopedic device, when the orthopedic device is worn by a user. 
     Referring to  FIGS.  9 - 12   , the orthopedic device may include a tibial pad  230  adapted to accommodate a user&#39;s lower leg, and permit universality of the orthopedic device. The tibia pad  230  may fill in a void defined between the second frame component  114  on a side of the brace, such as the medial side for reasons discussed below due to the anatomy of a lower leg. 
       FIG.  9    shows a cross-section of a lower leg and how the anterior aspect of the lower leg defines an apex. The medial side of the anterior aspect has a generally flat profile corresponding to the tibia and periosteum, whereas the lateral side has a rounded profile corresponding to the lateral muscle compartment. The orthopedic device is generally symmetrical between the lateral and medial sides to allow for universal sizing for left and right legs, and particularly the first and second frame components. Whereas the upper leg or thigh is generally symmetrical among left and right legs, the lower leg is not, as evidenced by  FIG.  9   . The second frame component can be contoured due to its malleability to the lower leg, and it may be difficult to obtain an accurate match for an individual user. With the tibia pad  230 , the shape of the second frame component  114  can be maintained without requiring guesswork of shaping the second frame component  114  itself. 
       FIG.  10    shows how the tibia pad  230  can be moved to either side of the center section  140  of the second frame component  114 , particularly in either corner  141 ,  143  of the center section  140 . The contours of the corners  141 ,  143  are symmetrical with one another, and the contour of the profile  240  permits adjustment of the tibia pad  230  at a variety of portions at each corner  141 ,  143  for adjustment to a user&#39;s individual anatomy, and for either left or right leg use. As shown in  FIG.  10   , the tibia pad is preferably sized and configured to fit within the width  162  of the center section  140 . 
       FIG.  11    illustrates the tibia pad  230  against the inner surface  246  of the second frame component  114 , and with the profile  240  adapted to the shape of the center section  140 . A liner  244  may be placed against the tibia pad  230  and the inner surface  246  of the second frame component  114 . The liner  244  is pliable and conforms to the shape of the second frame component  114  and the tibia pad  230 . The liner  244  may comprise foam and enables a generally uniform surface against the user&#39;s leg. 
       FIG.  12 A  shows an embodiment of the tibia pad  230  adapted for both right and left legs, and is adapted in combination with the lower frame component, as shown in  FIGS.  10  and  11   . The tibial pad  230  includes a substantially flat first surface  232  bounded by first and second ends  236 ,  238  of the tibia pad  230 . A profile  242  of the first surface  232  is generally adapted to a contour of the tibia of a user. The tibia pad  230  has a rounded second surface  234  having a profile  240  generally corresponding to the inner contour of the center section  140  of the second frame component  114 . 
       FIGS.  12 A and  12 B  show the tibia pad  230  as being preferably symmetric in shape from the first and second ends  236 ,  238  so as to accommodate either direction the tibia pad  230  is placed along the second frame component. As shown in the contoured configurations of the orthopedic device, the center section of the second frame component has a curvature as it extends between the first and second sections corresponding to lateral and medial sides of the orthopedic device and leg of the user. The tibia pad is configured and dimensioned to fit at a plurality of locations along the curvature of the second frame component. 
     The first surface  232  extends from a base portion  248  which assures a substantially flat surface from which the second surface  234  rises. To relieve any stress points and minimize discomfort, the tibia pad  230  includes tapering ends  252  which meet the first and second ends  236 ,  238  and merges with the base portion  248  in a graduated manner, and filleted side haunches  250 . The tapering ends  252  and filleted side haunches  250  ease donning of the brace, and prevent interference with any clothing, skin and hair along the leg. 
     The tibia pad  230  may be formed from a variety of padding materials. The tibia pad may be formed from ethylene vinyl acetate (EVA) type foam cut to shape, and having compressible properties, yet having sufficient rigidity. The rigidity supports against the leg and accommodates the void created by the generally uniform profile of the second frame component on the medial side of the orthopedic device against the tibia, for either left or right sided applications. 
     The tibia pad  230  may be secured to the frame component permanently or temporarily, or alternatively may be secured to the liner. The tibia pad may include hook material, and the frame component or the liner may include a loop material to which the hook material secures. Alternatively, the tibia pad may adhere to the frame component with an adhesive or other known fastener means. 
       FIG.  13    depicts a strap pad  209  arranged along the tibia strap  207  in  FIG.  8   . The tibia strap  209  in  FIG.  8    should extend between the hinge assemblies and can be adjustably lengthened according to desired tension, and the strap pad  209  is preferably dimensioned and configured to fit within a distance between hinge assemblies on lateral and medial sides of the orthopedic device. 
     A first surface  254  of the strap pad  209  is substantially flat and should face the leg of the wearer. A second surface  256  of the strap pad  209  is spaced from the first surface  254 , and a curved profile  262  extends from between the first and second surfaces  254 ,  256 , and first and second ends  258 ,  260  to provide a gentle taper of the strap pad  209  and improve cushioning. The strap pad  209  may be removably mounted to tibia strap  207  depending on the level of cushioning desired by the user. 
     It is to be understood that not necessarily all objects or advantages may be achieved under any embodiment of the disclosure. Those skilled in the art will recognize that the orthopedic device may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught without achieving other objects or advantages as taught or suggested. 
     The skilled artisan will recognize the interchangeability of various disclosed features. Besides the variations described, other known equivalents for each feature can be mixed and matched by one of ordinary skill in this art to construct an orthopedic device under principles of the present disclosure. It will be understood by the skilled artisan that the features described may be adapted to other types of orthopedic devices. Hence this disclosure and the embodiments and variations thereof are not limited to knee braces, but can be utilized in any orthopedic devices. 
     Although this disclosure describes certain exemplary embodiments and examples of an orthopedic device, it therefore will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed knee brace embodiments to other alternative embodiments and/or uses of the disclosure and obvious modifications and equivalents thereof. It is intended that the present disclosure should not be limited by the particular disclosed embodiments described above, and may be extended to orthopedic devices and supports, and other applications that may employ the features described.